Your next job in oncology is just a click away! Explore positions across the cancer care industry with CancerNetwork® Oncology Career Center.

CancerNetwork® Oncology Career Center

Listen to our latest episode of ONCOLOGY on The Go with insights from expert multidisciplinary professionals across the oncology space. 

ONCOLOGY On The Go Podcast

Get comprehensive coverage for the multidisciplinary oncology community with accurate, credible, and timely news and expert insights.

Subscribe to Our eNewsletter Today!

The March issue of ONCOLOGY features a review on the transition of surgical management of the axilla in breast cancer, as well as personalized treatment strategy options for PTCL. 

March ONCOLOGY Publication

The trial was terminated early due to no statistical significance observed between durvalumab and cetuximab for patients with head and neck squamous cell carcinoma.

For patients with head and neck squamous cell carcinoma who have a contraindication to cisplatin, radiotherapy plus durvalumab (Imfinzi) did not improve survival vs radiotherapy plus cetuximab (Erbitux), according to results from the phase 2/3 NRG-HN004 trial (NCT03258554) published in 

The median follow-up was 2.3 years. The 2-year progression-free survival (PFS) was 50.6% (95% CI, 41.5%-59.8%) in the durvalumab arm vs 63.7% (95% CI, 51.3%-76.1%) in the cetuximab arm (HR, 1.33; 95% CI, 0.84-2.12; 

At the interim futility analysis, the median follow-up was 6.4 months, with 37 patients having a PFS event including 22% in the durvalumab group and 21% in the cetuximab group. The 2-year PFS for patients with p16 status and treatment group interaction were not statistically significant (

The protocol-specified analysis had a median follow-up of 1.2 years with 42% of patients in the durvalumab group having a PFS event vs 29% in the cetuximab group. The median PFS was 2.2 years (95% CI, 1.2-not reached [NR]) vs 2.7 years (95% CI, 2.7-NR) in either arm (HR, 1.47; 95% CI, 0.86-2.52; 

 = .92). The 2-year PFS estimates were 51.0% (95% CI, 40.7%-61.2%) vs 66.4% (95% CI, 52.8%-80.1%).

The HR for treatment effect was 1.05 (95% CI, 0.53-2.09) which crossed the protocol-specified boundary of 1. Because of the results with similar distribution of disease-specific events that led to the PFS end point, the NRG Oncology Data Monitoring Committee recommended permanent accrual closure. Additionally, with any additional follow-up, 69 PFS events were required for the phase 2 primary end point analysis.

The null hypothesis for this trial was that no difference in PFS would be observed between either arm.

“The trial was intended to go a lot longer than it did, and the goal was to recruit a lot more patients than it ended up recruiting. The reason that it didn’t is because it closed early, because the planned analysis of the data at that point showed that the experimental arm was not performing as well as the control arm,” study author Christina E. Henson, MD, Residency Program Director for Radiation Oncology at OU Health, said in an interview with CancerNetwork®. “What we saw [after] following the patients for 2 years after they received treatment, was that the cure rate was about 13% lower actually in the experimental arm, which is a pretty big difference.”

In the phase 2 portion of the trial that took place from March 12, 2019, to July 30, 2021, a total of 190 patients were enrolled and 186 were randomly assigned to either the durvalumab arm (n = 123) or the cetuximab arm (n = 63). The median age was 72 years old, with 59% being 70 years or older. Overall, the majority were men (84%), White (83%), and had p16-positive oropharyngeal or unknown primary disease (47%).

Contraindications to cisplatin included hearing loss (49%), renal insufficiency (28%), grade 1 or higher peripheral neuropathy (21%), and an ECOG performance status of 2 (12%). For those who did not have contraindications, they were 70 years or older with a moderate or severe comorbidity (9%), or younger than 70 years with a severe comorbidity (8%). The median number of comorbidities was 5.

During extended follow-up, 58 patients had died. The post-hoc median overall survival was not reached in either arm (HR, 1.30; 95% CI, 0.74-2.28; 

 = .82). Similar results were observed when adjusted for stratification factors, except for p16 status (

The post-hoc 2-year OS estimated were 69.3% (95% CI, 60.8%-77.8%) in the durvalumab arm vs 77.5% (95% CI, 66.7%-88.3%) in the cetuximab arm.

Locoregional failure was observed in 31% of patients in the durvalumab arm and 19% in the cetuximab arm, with 11% vs 14% having distant metastasis events. Competing mortality events between either arm were observed in 9% vs 6% of patients.

The most common grade 3/4 adverse effects (AEs) included dysphagia (22% vs 30%), lymphopenia (28% vs 33%), and oral mucositis (11% vs 18%) between the durvalumab and cetuximab arms, respectively. In the durvalumab group, 9% of patients died vs 2% in the cetuximab group due to AEs.

Treatment-related serious AEs that were most common included aspiration (3% vs 3%), dehydration (4% vs 7%), dysphagia (3% vs 7%), dyspnea (3% vs 2%), and laryngeal edema (3% vs 0%). Death from treatment-related serious AEs was noted in 3% of patients in the durvalumab group vs 2% in the cetuximab group

One year after the end of radiotherapy, 19.0% (95% CI, 12.1%-28.7%) of patients in the durvalumab group vs 16.3% (95% CI, 8.1%-30.0%) in the cetuximab group had a feeding tube (

“It’s always disappointing when we have a trial that comes out to be negative and that we didn’t find something that benefits our patients, but it also can show us the importance of a good trial design, and help us to better design future trials,” Henson concluded.

Mell LK, Torres-Saavedra PA, Wong SJ, et al. Radiotherapy with cetuximab or durvalumab for locoregionally advanced head and neck cancer in patients with a contraindication to cisplatin (NRG-HN004): an open-label, multicentre, parallel-group, randomised, phase 2/3 trial. 

. 2024;25(12):1576-1588. doi:10.1016/S1470-2045(24)00507-2

Articles

Durvalumab Is Not Statistically Significant Vs Cetuximab in HNSCC

Deborah Stephens, DO, associate professor of Medicine, director of the CLL and Richter’s Program, and physician leader of the CLL and Lymphoma Research Program at the University of North Carolina School of Medicine

Jacob D. Soumerai, MD, clinical investigator in Lymphoma and assistant professor in Medicine at Massachusetts General Hospital

In an interview with CancerNetwork®, Deborah Stephens, DO, an associate professor of Medicine, director of the CLL and Richter’s Program, and physician leader of the CLL and Lymphoma Research Program at the University of North Carolina School of Medicine; and Jacob D. Soumerai, MD, a clinical investigator in Lymphoma and assistant professor in Medicine at Massachusetts General Hospital, highlighted emergent advancements in clinical practice for patients with chronic lymphocytic leukemia (CLL) following a Lymphoma Research Foundation (LRF)–endorsed CLL working group.

Initially, challenges related to CLL were discussed, with Stephens highlighting the multiplicity of viable targeted treatment options and Soumerai describing that the subtle differences in these treatment options inspired the establishment of the CLL workshop to inform therapeutic decision-making. Furthermore, Soumerai discussed frontline treatment options for patients with asymptomatic CLL, particularly those seeking time-limited therapies. Stephens further identified treatment options in the second-line setting and beyond, touching upon BTK inhibition as well as bispecific use in this patient population.

Furthermore, Stephens and Soumerai disclosed points that resonated with them at the CLL workshop, with the former highlighting the use of minimal residual disease (MRD) and BTK resistance mutations in informing clinical practice and the latter emphasizing the importance of engaging patients in shared decision-making processes. Then, Soumerai discussed the establishment of a clinical guide intended to inform practice for clinicians managing CLL and educate patients regarding the implications of their treatment options. Stephens further expressed that the establishment of the guide was intended to provide a more comprehensive source to inform clinicians as well as give patients a sense of agency in advocating for their treatment decisions.

CancerNetwork: What are some challenges related to CLL that health care professionals are currently facing?

 There are many great things that are happening for physicians in the management of CLL because there are many [effective] targeted treatments that are available. Challenges result around trying to figure out how to sequence the therapy and pick the best treatment that comes first in line so we can still [treat] the patients in the second or third line. A part of that comes because the challenge is not having a cure for CLL yet. We are talking about sequencing treatments because there is not one treatment that the patients can receive and then complete.

Another challenge I would say that faces clinicians is that unlike a lot of other lymphoid malignancies, CAR T and transplant have been successful in helping patients, whereas with CLL, there’s a lot of morbidity associated with it. Due to the age of patients, it’s hard to get patients well enough and in remission [to be] in a good spot to go to transplant or CAR T. Those are some of the main features that are affecting physicians right now.

We are in a space where there are so many options that one of the most difficult things about treating patients with CLL is keeping up with the subtle differences in some of these therapies and the effects on the patients we are caring for. That has served as the foundation for the [CLL working group]. How do we meet that problem by giving clinicians all the information about the differences in these treatments, the differences in patients that help guide whether we should be recommending one treatment approach vs another and [making] all the different decisions that spiral after that initial treatment decision is made?

What ongoing clinical trials are currently evaluating treatments for patients with CLL?

There are many ongoing clinical trial efforts, some of which have been completed, and we are simply awaiting the data to inform clinical practice. One way to [review these trials] would be to start from diagnosis. There’s an important intergroup study, the phase 3 SWOG 1925 study [NCT04269902], which is evaluating whether we can take patients with asymptomatic CLL who do not meet current accepted standard criteria for the initiation of therapy, and identify those patients who have a higher risk for an unfavorable CLL outcome using something called the CLL-International Prognostic Index [CLL-IPI] risk tool.

 It is also testing whether, in this select group of patients, early treatment with time-limited therapy with venetoclax [Venclexta] and obinutuzumab [Gazyva] might improve their outcomes.

This is an effort that Stephens is playing a major role in leading, and it does have the potential, in the future, to inform the care of patients. Right now, the clear standard of care is to observe, without treatment, patients who are asymptomatic and do not meet these criteria. But this is an important study.

There is an important study that was presented at the 2024 American Society of Hematology [ASH] Annual Meeting called the phase 3 AMPLIFY trial [NCT03836261].

 This was a trial that compared the combination of acalabrutinib [Calquence] and venetoclax with or without obinutuzumab [vs] chemotherapy. This was a positive study––the combination of acalabrutinib/venetoclax ± obinutuzumab was superior to chemotherapy and is likely to lead to this being approved in the frontline setting for patients with CLL.

This is an interesting regimen. Patients like time-limited therapy, but there is also an interest in not receiving the infusional therapy: the obinutuzumab antibody therapy. For a patient who is more inclined towards time-limited treatment and does not want the infusion but may be a good candidate for a BTK inhibitor on the basis of their medical history and other factors, this is likely to be a compelling option.

There are other data that are ongoing. There is a regimen of a newer BCL2 inhibitor called sonrotoclax [BGB-11417], which is being combined with zanubrutinib [Brukinsa]. We saw some exciting data showing that this [combination] is associated with favorable safety outcomes but also high rates of undetectable MRD. There is an ongoing randomized trial that has completed accrual we are awaiting the results of called [the phase 3] CELESTIAL-TNCLL [NCT06073821] study, which compares this regimen against venetoclax/obinutuzumab.

This is just the beginning. There are many other trials that are ongoing and are potentially poised to change the standard of care for CLL.

 Another exciting trial, along the same lines in the frontline setting, is the phase 3 CLL17 study [NCT04608318]. That is looking at [whether we can] do time-limited therapy with venetoclax and obinutuzumab, or potentially therapy with ibrutinib [Imbruvica] and venetoclax, compared to continuous therapy with ibrutinib.

 It’s the first study that has compared this continuous therapy with the other novel targeted agents.

The study is going to be a bit of a challenge to interpret once it’s completed because when it was designed, ibrutinib was the standard BTK inhibitor that most people used. Now, with acalabrutinib and zanubrutinib, most people use these next-generation inhibitors. It’s going to be an important study because it looks at all targeted, time-limited therapies vs indefinite therapy. There are some weak spots because ibrutinib is the BTK inhibitor that was used, but it will still provide important data.

In the second-line setting, important recent studies that were presented included the phase 3 BRUIN CLL-321 study [NCT04666038], which looked at the third-generation BTK inhibitor pirtobrutinib [Jaypirca], which is currently approved in the third-line setting for patients with CLL after treatment failure of [prior] BTK inhibition and venetoclax.

 This clinical trial looked at the second-line setting. There were a fair number of patients who [had recently received] BTK inhibition, and the thought was that they will use that to apply for getting pirtobrutinib in earlier lines of therapy.

[Regarding] later lines of therapy, there are still many great novel agents that we do not quite know how to use yet but are showing great activity––things like BTK-degrading agents. Those are exciting because they work even when BTK inhibitors do not work anymore. [Investigators are] taking a different approach with the bispecific antibodies like epcoritamab-bysp [Epkinly], glofitamab-gxbm [Columvi] and mosunetuzumab-axgb [Lunsumio] by looking at their effects. Those are still fairly early studies.

Were there any points brought up while attending the CLL working group that resonated with you?

 This was a nice group of physicians from across the country that all agreed to work with the LRF to come up with some practical guidelines. It was a great collaborative group. We spent a lot of time workshopping and trying to get complete agreement and consensus between all of the experts. There were a couple of key pieces that I felt still took a lot of discussion, and there was not a clear consensus on them. That [includes] the use of MRD and how to use it in clinic. Should we be guiding therapy by it? Another piece was, should we be using BTK resistance mutations in clinical practice? Because there was not a consensus, we decided that it’s not quite ready for mainstream [practice], but there is a lot of clinical trials ongoing that hope to help address how to best use this in clinical practice.

For most patients with CLL, the primary decision-making is that choice of initial therapy. One thing that really resonated for me was the fact that we have so many factors that drive the decision-making. But at the end of the day, probably for a majority of patients, there are multiple reasonable treatment approaches. One of the key things is the importance of engaging patients. There are some interesting data that we cited in that most patients want to participate in these discussions. They want to be engaged in a shared decision-making discussion regarding their treatment decisions, yet less than half of patients actually report having this opportunity.

What material is contained within the clinical guide inspired by the CLL working group?

There are 3 main outputs of this effort. The first is a clinical guide that’s directed at clinicians. This is now published in 

 and includes information on, [for example], what is the standard workup?

 How do we approach the workup of a patient with newly diagnosed CLL or prior to any line of therapy subsequent to that? How do we make the decision to initiate therapy once we make this decision? What are the factors that influence treatment selection? Once we go down an initial line of therapy and a patient requires a change in therapy, how do we make that decision from the beginning at diagnosis all the way through a patient’s life with CLL? All that information is in this primary clinical guideline, but there are 2 additional pieces here.

The LRF is an outstanding organization that supports patients. One of the things we wanted to do was provide all the same data [and] guideline information to patients in parallel. Along with the LRF, we helped to develop a lay summary version of the guidelines. This is something that should be available soon on the LRF website and will provide patients with the same information. There are, again, 2 outputs here. One is an English version, and the other is a Spanish version. The hope is that all of this [work] will form the basis for future educational efforts targeting both clinicians and patients.

How will the integration of the guide into clinical practice enhance treatment for patients?

As a part of this workshop, we focused on trying to make these timely and intuitive guidelines for physicians. [We tried] to get beyond what is provided by other guidelines, like the NCCN guidelines, [to offer] a more candid discussion of why we would do one thing or another. If a clinician reads that, they have a good idea on what’s recommended by a large panel of experts––they have some rationale behind it. I hope that leads to better patient care over time in addition to the patient-directed materials. Patients can come into their clinic visits prepared. If they have read the guidelines, they could be prepared with intuitive questions and can help to guide their own care.

Stephens DM, Moseley A, Hill BT, et al. Randomized, phase III study of early intervention with venetoclax and obinutuzumab versus delayed therapy with venetoclax and obinutuzumab in newly diagnosed asymptomatic high-risk patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL): EVOLVE CLL/SLL study (SWOG S1925, NCT#04269902). 

 2021;39(suppl 15):TPS7567. doi:10.1200/JCO.2021.39.15_suppl.TPS7567

Brown JR, Seymour JF, Jurczak W, et al. Fixed-duration acalabrutinib plus venetoclax with or without obinutuzumab versus chemoimmunotherapy for first-line treatment of chronic lymphocytic leukemia: interim analysis of the multicenter, open-label, randomized, phase 3 AMPLIFY trial. 

2024;144(suppl 1):1009. doi:10.1182/blood-2024-200701

Shadman M, Kater AP, Woyach JA, et al. CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL. 

 2024;42(16):TPS7087. doi:10.1200/JCO.2024.42.16_suppl.TPS7087

Ibrutinib monotherapy versus fixed-duration venetoclax plus obinutuzumab versus fixed-duration ibrutinib plus venetoclax in patients with previously untreated chronic lymphocytic leukaemia (CLL) (CLL17). ClinicalTrials.gov. Updated December 31, 2024. Accessed March 7, 2025. https://tinyurl.com/bdf4dsn3

Sharman JP, Munir T, Grosicki S, et al. BRUIN CLL-321: randomized phase III trial of pirtobrutinib versus idelalisib plus rituximab (IdelaR) or bendamustine plus rituximab (BR) in btk inhibitor pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma. 

2024;144(suppl 1):886. doi:10.1182/blood-2024-198147

FDA grants accelerated approval to pirtobrutinib for chronic lymphocytic leukemia and small lymphocytic lymphoma. News release. FDA. December 1, 2023. Accessed March 7, 2025. https://bit.ly/48011OO

Soumerai JD, Barrientos JC, Ahn IE, et al. Consensus recommendations from the 2024 Lymphoma Research Foundation Workshop on treatment selection and sequencing in CLL or SLL. 

 Published online November 19, 2024. doi:10.1182/bloodadvances.2024014474

Clinical guidelines aimed at both clinicians and patients seek to educate and include both parties in clinical decision-making processes.

Highlighting Developments and Informing Treatment Planning in CLL Care

One presentation will highlight updated overall survival (OS) findings from the phase 3 MIRASOL trial (NCT04209855) assessing mirvetuximab soravtansine-gynx vs chemotherapy for patients with folate receptor alpha (FRα)–positive platinum-resistant epithelial ovarian cancer.

Tomorrow, experts in gynecologic oncology will convene in Seattle, Washington to present key developments and research efforts in the field as part of the 

2025 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer (SGO).

 The meeting will feature a variety of multidisciplinary oncology professionals who are geared to detail findings that may impact the management of ovarian cancer, cervical cancer, endometrial cancer, and other gynecologic malignancies.

Here are some of the topics and sessions that may inform treatment planning for patients with different gynecologic cancers:

(ENCORE) Avutometinib + defactinib in recurrent low grade serous ovarian cancer (ENGOT-OV60/GOG-3052/RAMP 201): dose-intensity and subgroup analysis

This year’s SGO meeting will feature an encore of subgroup analysis data from the phase 2 RAMP 201 trial (NCT04625270) evaluating the RAF/MEK inhibitor avutometinib in combination with the FAK inhibitor defactinib for adults with recurrent low-grade serous ovarian cancer. These findings related to dose intensities and patient subgroups may build upon prior outcomes achieved with the avutometinib regimen and have regulatory implications.

FDA previously accepted a new drug application for avutometinib/defactinib

 as a treatment for this patient population, specifically those with 

-mutated disease and who received at least 1 prior line of treatment, in December 2024 based on findings from the RAMP 201 trial.

If approved, the avutometinib combination would become the first commercially available treatment for patients with recurrent 

-mutated low-grade serous ovarian cancer.

Investigators previously presented primary analysis data from the trial at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting.

 Data from the primary analysis showed a confirmed overall response rate (ORR) of 31% (n = 34/109; 95% CI, 23%-41%) after a follow-up of approximately 12 months and a data cutoff date of June 30, 2024. Additionally, the ORR was 44% (n = 25/57; 95% CI, 31%-58%) in patients with 

mutant disease and 17% (n = 9/52; 95% CI, 8%-30%) in those with 

Final overall survival analysis among patients with folate receptor alpha-positive, platinum-resistant ovarian cancer treated with mirvetuximab soravtansine versus investigator's choice chemotherapy in phase II MIRASOL (GOG-3045/ENGOT-ov55) study

One presentation will highlight updated overall survival (OS) findings from the phase 3 MIRASOL trial (NCT04209855) assessing mirvetuximab soravtansine-gynx (Elahere) vs chemotherapy for patients with folate receptor alpha (FRα)–positive platinum-resistant epithelial ovarian cancer. Data from this final analysis may affirm the benefits observed with earlier reports of mirvetuximab soravtansine that led to the 

 for previously treated FRα–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in March 2024.

Additionally, in a poster presentation at the 

2024 European Society for Medical Oncology (ESMO) Congress,

 investigators highlighted OS findings after a median follow-up of 20.3 months (range, 19.3-21.4).

 At the time of this analysis, the median OS was 16.46 months (95% CI, 14.36-19.88) with mirvetuximab vs 13.34 months (95% CI, 11.37-15.44) with chemotherapy (HR, 0.67; 95% CI, 0.53-0.86; 

Pembrolizumab plus chemoradiotherapy for high-risk locally advanced cervical cancer: overall survival and progression-free survival 2 results from the randomized, double-blind, phase III ENGOT-cx11/GOG-3047/KEYNOTE-A18 study

In another plenary session, additional OS and progression-free survival (PFS)-2 data from the 

 trial will be detailed. As part of this randomized, placebo-controlled trial, investigators assessed pembrolizumab (Keytruda) in combination with chemoradiotherapy (CRT) vs placebo/CRT among patients with newly diagnosed, previously untreated, high-risk, locally advanced cervical cancer.

Prior findings presented at the 2024 ESMO Congress showed that the OS rate at 36 months was 82.6% (95% CI, 78.4%-86.1%) in the pembrolizumab arm vs 74.8% (95% CI, 70.1%-78.8%) in the placebo arm.

 The median OS was not reached (NR) in both arms at the time of analysis (HR, 0.67; 95% CI, 0.50-0.90; 

FDA approved pembrolizumab plus external beam radiotherapy, concurrent chemotherapy, and brachytherapy

 for patients with FIGO stage III to IVA cervical cancer based on findings from the KEYNOTE-A18 trial.

Durvalumab plus carboplatin/paclitaxel followed by durvalumab with/without olaparib in endometrial cancer: Biomarkers, histological heterogeneity, baseline circulating tumor DNA and efficacy in the DUO-E mismatch repair proficient subpopulation

Another late-breaking abstract presentation will offer a closer look at outcomes achieved with a durvalumab (Imfinzi)-based regimen in a subgroup of patients with mismatch repair proficient (pMMR) advanced or recurrent endometrial cancer enrolled in the 

These findings may build upon data presented at the 2024 SGO Annual Meeting, in which durvalumab plus carboplatin/paclitaxel followed by maintenance durvalumab with or without olaparib (Lynparza) improved PFS vs chemotherapy alone regardless of mismatch repair status.

Across the intent-to-treat population, the median PFS was 9.6 months (95% CI, 9.0-9.9) with chemotherapy alone vs 10.2 months (95% CI, 9.7-14.7) with chemotherapy/durvalumab (HR, 0.71; 95% CI, 0.57-0.89; 

 = .003). With the addition of maintenance olaparib to durvalumab/chemotherapy, the median PFS was 15.1 months (95% CI, 12.6-20.7), reducing the risk of progression or death vs chemotherapy alone (HR, 0.55; 95% CI, 0.43-0.69; 

 <.0001) and chemotherapy/durvalumab (HR, 0.71; 95% CI, 0.57-0.89; 

the FDA approved durvalumab plus chemotherapy followed by durvalumab maintenance

 for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) in June 2024 based on prior findings from the DUO-E trial.

According to a press release issued by SGO, this study “underscores the importance of biomarker-driven treatment” and shows that “by identifying which patients are most likely to benefit from combination therapy, providers can better tailor treatments and improve outcomes.”

Chemotherapy with or without pembrolizumab followed by maintenance with olaparib or placebo for first-line treatment of advanced BRCA non-mutated epithelial ovarian cancer: results from the randomized phase 3 ENGOT-OV43/GOG-3036/KEYLYNK-001 study

Another plenary session will reveal detailed outcomes from the double-blind phase 3 KEYLYNK-001 study (NCT03740165) investigating pembrolizumab plus chemotherapy followed by pembrolizumab and maintenance olaparib with or without bevacizumab (Avastin) as frontline therapy for 

 non-mutated advanced epithelial ovarian cancer.

According to a press release in December 2024, a prior analysis conducted by an independent data monitoring committee showed that pembrolizumab-based treatment elicited a statistically significant and clinically meaningful improvement in the primary end point of PFS.

 The secondary end point of OS was not reached at the time of this analysis.

The press release stated that investigators intend to discuss findings from the KEYLYNK-001 study with regulatory authorities. Specific data highlighted at the 2025 SGO Meeting may support a regulatory pathway for the pembrolizumab-based regimen in this epithelial ovarian cancer population.

Verastem Oncology announces FDA acceptance and priority review of new drug application for avutometinib in combination with defactinib for the treatment of recurrent KRAS mutant low-grade serous ovarian cancer. News release. Verastem Oncology. December 30, 2024. Accessed March 11, 2025. https://tinyurl.com/57brbv3n

Verastem Oncology presents positive updated RAMP 201 data for avutometinib and defactinib combination in recurrent low-grade serous ovarian cancer at the International Gynecologic Cancer Society (IGCS) 2024 Annual Meeting. News release. Verastem Oncology. October 17, 2024. Accessed March 11, 2025. https://tinyurl.com/zuxdeuwh

FDA approves mirvetuximab soravtansine-gynx for FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. News release. FDA. March 22, 2024. Accessed March 11, 2025. https://tinyurl.com/2apx6e5s

Coffman LG, You B, Hamilton EP, et al. 746P Phase III MIRASOL trial: updated overall survival results of mirvetuximab soravtansine (MIRV) vs. investigator’s choice chemotherapy (ICC) in patients (pts) with platinum-resistant ovarian cancer (PROC) and high folate receptor-alpha (FRα) expression. 

2024;35(suppl 2):S566. doi:10.1016/j.annonc.2024.08.807

Lorusso D, Xiang Y, Hasegawa K, et al. Pembrolizumab or placebo with chemoradiotherapy followed by pembrolizumab or placebo for newly diagnosed, high-risk, locally advanced cervical cancer (ENGOT-cx11/GOG-3047/KEYNOTE-A18): overall survival results from a randomised, double-blind, placebo-controlled, phase 3 trial. 

. Published online September 14, 2024. doi:10.1016/S0140-6736(24)01808-7

FDA approves pembrolizumab with chemoradiotherapy for FIGO 2014 stage III-IVA cervical cancer. News release. FDA. January 12, 2024. Accessed March 11, 2025. https://shorturl.at/pswHW

Chon HS, Thomas-Pepin J, Sundborg MJ, et al. Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for endometrial cancer (DUO-E/GOG-3041/ENGOT-EN10): objective response rate and duration of response by mismatch repair status. Presented at: SGO 2024 Annual Meeting on Women’s Cancer; March 16-18, 2024; San Diego, CA.

FDA approves durvalumab with chemotherapy for mismatch repair deficient primary advanced or recurrent endometrial cancer. News release. FDA. June 14, 2024. Accessed March 11, 2025. https://tinyurl.com/mvhx997f

Press release 6: personalized approaches to endometrial cancer detection and treatment. News release. SGO. Accessed March 12, 2025. https://tinyurl.com/mrypjtjn

Merck announces phase 3 KEYLYNK-001 trial met primary endpoint of progression-free survival (PFS) in patients with advanced epithelial ovarian cancer. News release. Merck. December 9, 2024. Accessed March 11, 2025. https://tinyurl.com/yty2r89a

The 2025 SGO meeting will feature readouts of potentially impactful trial data in ovarian cancer, cervical cancer, and other gynecologic malignancies.

A Glimpse at Practice-Shifting Presentations at The 2025 SGO Annual Meeting

Based on positive safety data from the third cohort, a safety review committee approved the opening of a fourth cohort as well as more enrollment into the third cohort.

A fourth cohort will be opening in the phase 1/2 trial (NCT06260774) evaluating the safety and tolerability of TTX-MC138, a first-in-class therapeutic candidate targeting microRNA-10b, as a treatment in patients with advanced solid tumors, according to a press release from the developer, TransCode Therapeutics.

The safety review committee that was monitoring the trial unanimously approved the addition of the extra cohort after a favorable review of the third cohort’s safety data. The committee also approved the enrollment of more patients into cohort 3. Patients are currently being evaluated for eligibility in cohort 4.

Pharmacokinetic and pharmacodynamic data from patients in cohort 1 and cohort 2 were consistent with what was observed in the phase 0 trial (NCT05908773). Of the 9 patients enrolled in the first 3 cohorts, 6 remain on treatment due to the absence of dose limiting toxicities and disease progression. No significant safety or dose limiting toxicities were reported in cohorts 1, 2, and 3.

Early results from a pharmacokinetic analysis demonstrated that the dose levels from cohorts 1 and 2, 0.8 mg/kg to 1.6 mg/kg, represent an efficacious range.

“The [safety review committee] approval to open the fourth cohort and expand enrollment in cohort 3 is an important advancement for the clinical trial. It will provide an opportunity to obtain additional safety and [pharmacokinetic/pharmacodynamic] data, inform the dose expansion stage of the clinical trial and may allow us to obtain initial evidence of clinical activity,” Sue Duggan, senior vice president of Operations at TransCode stated in the press release.

 “Enrollment into the study continues based on the cumulative safety data review. Eligible subjects may now be screened and scheduled in cohort 4 for treatment with the next dose level of TTX-MC138 while preliminary data analysis continues.”

The multicenter, open-label, dose-escalation and expansion trial has currently treated 9 patients who have a variety of metastatic solid cancers with TTX-MC138; there was an initial dose-escalation stage followed by a dose-expansion stage. Dosage was increased incrementally in cohorts subsequent to the first to find the maximum tolerated dose.

Patients in cohort 1 received 0.4 mg/kg of TTX-MC138, patients in cohort 2 received 0.8 mg/kg, and patients in cohort 3 received 3.2 mg/kg.

 Treatment cycles were 28 days long and patients received 1 dose of TTC-MC138 via intravenous infusion on day 1 of every cycle.

Eligible patients were 18 years or older and had a histologically or cytologically confirmed diagnosis of relapsed or refractory metastatic or locally advanced solid tumor where no standard therapy exists, standard therapy has failed, and standard therapies have no known clinical benefit. Additionally, patients had measurable or evaluable disease per RECIST v1.1, an ECOG performance status from 0 to 2, a life expectancy of 3 months or greater, and adequate organ function.

Those who had history of a second malignancy that required active therapy in the past year, received anticancer therapy within 14 days or 5 half-lives of study drug administration, had central nervous system metastases, required treatment with traditional/herbal medicines, had any severe or uncontrolled systemic disease or condition, had a history of acute ischemic stroke, had a clinical diagnosis of hemochromatosis or secondary iron overload, and have any unresolved clinically relevant toxicities from prior therapies were excluded from participating in the trial.

The trial’s end points in the dose escalation phase were adverse effects defined as the safety and tolerability of escalating dose levels to determine the incidence of treatment-emergent adverse events and overall response rate defined as the proportion of patients to achieve complete response, partial response, or stable disease for at least 8 weeks per RECIST v1.1.

In the abstract of a presentation given on the phase 0 trial of TTX-MC138 at the 

2024 American Society of Clinical Oncology (ASCO) Annual Meeting

, lead study author Zdravka Medarova, PhD, an associate professor of Radiology at Harvard Medical School, and coauthors, wrote that the therapy “represents a first step towards developing effective nucleic-acid based therapeutics against cancer.”

TransCode Therapeutics announces safety review committee approval to open fourth cohort in phase I/II clinical trial. News release. TransCode Therapeutics, Inc. March 13, 2025. Accessed March 13, 2025. https://tinyurl.com/2zrxdxad

Study of TTX-MC138 in subjects with advanced solid tumors. ClinicalTrials.gov. Updated January 27, 2025. Accessed March 13, 2025. https://tinyurl.com/4mrbdn7u

Medarova Z, Robertson N, Ghosh S, et al. Initial clinical experience with the first-in-class anti-metastasis therapeutic TTXMC138.

. 2024;42(supp_16):e15072. doi:10.1200/JCO.2024.42.16_suppl.e15072

New Cohort Approved in Phase 1/2 Trial of TTX-MC138 in Solid Cancers

multidisciplinary oncology professionals takeaways from the covid-19 pandemic 

In March 2020, the COVID-19 pandemic altered day-to-day life in the US and the world. Specifically, patients who had cancer and were receiving treatment were one of the most vulnerable populations because of their weakened immune systems. Overnight, the health care industry had to adapt to new protocols and find ways to safely treat these patients without exposing them to additional life-threatening circumstances.

Now, 5 years after the pandemic began, CancerNetwork and clinicians in the multidisciplinary space are taking a look back to see what changes were implemented and whether they impacted the oncology field for better or for worse. During this time, institutions across the country, societies, and nonprofit organizations have created resources regarding the COVID-19
pandemic and how to best move forward.

Studies have been conducted during the past 5 years regarding the impact the pandemic had on cancer care. Most importantly, they looked at populations and access to care.

The American Cancer Society (ACS) has created a comprehensive guide regarding questions patients or clinicians may have about COVID-19 and cancer care.

 The Memorial Sloan Kettering (MSK) Cancer Center library discusses the use of COVID-19 treatment for patients with cancer as well.

 They noted that patients with cancer have a higher rate of progressing with COVID-19 and, therefore, should receive anti–SARS-CoV-2 therapies in the outpatient setting.

MSK also highlighted that for patients who need supplemental oxygen or mechanical ventilation, the use of dexamethasone has been shown to lower mortality. For patients with severe or critical COVID-19 who have respiratory decompression, dexamethasone plus tocilizumab (Actemra) and baricitinib (Olumiant) are recommended.

One of the resources on the ACS platform directs clinicians to the COVID-19 and Cancer Consortium (CCC19), which is currently evaluating 126 institutions and looking into the effects of the pandemic on the institutions as a whole, specific patient populations, and by disease type.

One such study looked at racial disparities in COVID-19 outcomes among patients who are Black or White with cancer.

 The study found that of the 3506 patients, patients who were Black had worse illness and worse COVID-19 severity than those who were White (unweighted OR, 1.34; 95% CI, 1.15-1.58; weighted OR, 1.21; 95% CI, 1.11-1.33).

“What came out of the pandemic was this recognition of the importance of these upstream structural and social drivers of health, as we recognize that there were populations right here in our country that were more impacted than others in terms of being infected, as well as outcomes following infection. The pandemic has helped to pave recognition of the importance of upstream factors,” Scarlett Lin Gomez, PhD, MPH, professor in the Department of Epidemiology and Biostatistics and coleader of the Cancer Control Program at the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, said during an interview with CancerNetwork.

The Joint Research Centre, which is part of the European Commission, conducted a survey and published the results in February 2023.

 Researchers looked at European cancer registries between March and May 2020 to better understand how the first wave of the pandemic impacted cancer screenings.

Overall, about 90% of patients reported an interruption or slowdown of population-based screening for breast, cervical, and colorectal cancers. Additionally, surgery was disrupted in 51% of respondents, chemotherapy in 43%, immunotherapy in 44%, and radiotherapy in 40%.

“[COVID-19] did affect the care of screening. Many patients fell off as far as getting their colonoscopies, which probably meant an increased incidence of more advanced disease because, for a few years, some patients didn’t get their mammography or colonoscopy, etc. Now we’re playing catch-up in that situation,” Marwan G. Fakih, MD, professor in the Department of Medical Oncology and Therapeutics Research, associate director for Clinical Sciences, medical director of the Briskin Center for Clinical Research, division chief of Gastrointestinal Medical Oncology, and codirector of the Gastrointestinal Cancer Program at City of Hope, said during an interview.

A major consensus across all clinicians was the use of telehealth and its positive impact on the health care space. A systematic review published in 2024 assessed the effectiveness of telehealth compared with in-person care during the pandemic. Differences in health care utilization were noted as small and/or not clinically meaningful.

 For process outcomes, there were lower rates of missed visits and changes in therapy or medication, with higher rates of adherence for those who had initial telehealth visits. The rates of laboratory results or paraclinical assessment were found to be lower among those with initial telehealth visits.

In 2024, the House Ways and Means Committee passed the Preserving Telehealth, Hospital and Ambulance Access Act.

 This was to further expand the regulatory flexibility to telehealth put in place during the COVID-19 pandemic, but coverage was set to expire in 2024. At the beginning of the pandemic, the Centers for Medicare & Medicaid Services had enabled widespread use of telehealth, such as virtual visits across state lines, audio-only care, and waiving in-person requirements for prescriptions.

 In December 2024, an extension was made through March 31, 2025, which allowed Medicare and hospital-at-home services, like telehealth, to continue to be covered.

“The role of telehealth and for patients to do visits remotely has been a good thing. We’ve been able to provide patients care, be able to connect with them, and get the information that we need. The only limitation is the inability to do the physical examination and vitals. [Telehealth] has enhanced care,” Ritu Salani, MD, MBA, director of gynecologic oncology at UCLA Health and editorial advisory board member for 

Over the past 5 years, countless research articles have come out not just in the cancer space but in health care in general regarding the pandemic. The public health emergency was ended in May 2023, but questions remain about the impact of COVID-19 and cancer care.

The European Commission highlighted key points on what to expect after the pandemic, including a lower reported number of cancer incident cases from 2020, higher stage at diagnosis, and a negative impact on survival.

Organizations like CCC19 are still looking at and compiling data regarding the pandemic. Long-term follow-up is occurring, and it will be important to look at these results and analyze how future pandemics may impact patients with cancer.

“The COVID-19 pandemic showed how resilient not only patients can be but medicine as a field, that if we’re up against something, we find ways to adapt or try to make things better, to adjust to the pandemic,” Frances Elaine Chow, MD, a neuro-oncologist at USC Norris Comprehensive Cancer Center, concluded. “Hopefully, we won’t run into other pandemics or world-changing conditions, but we will continue to evolve and develop as a field to make things easier for our patients.”

Questions about COVID-19 and cancer. American Cancer Society. March 25, 2024. Accessed February 5, 2025. https://shorturl.at/RwwNP

COVID-19. Memorial Sloan Kettering Library. Updated February 5, 2025. Accessed February 5, 2025. https://shorturl.at/SiHL4

The COVID-19 and Cancer Consortium. Accessed February 5, 2025. https://shorturl.at/xlOnV

Fu J, Reid SA, French B, et al. Racial disparities in COVID-19 outcomes among Black and White patients with cancer. 

 2022;5(3):e224304. doi:10.1001/jamanetworkopen.2022.4304

Cancer care in times of COVID-19: lessons for future pandemics. EU Science Hub. February 28, 2023. Accessed February 5, 2025. https://shorturl.at/79Wsj

Hatef E, Wilson RF, Zhang A, et al. Effectiveness of telehealth versus in-person care during the COVID-19 pandemic: a systematic review. 

. 2024;7(1):157. doi:10.1038/s41746-024-01152-2

Henry TA. Bill to extend telehealth flexibilities clears House committee. American Medical Association. August 15, 2024. Accessed February 5, 2025. https://shorturl.at/oczue

Seegert L. Congress extends more telehealth care just before the 2024 holidays. Penn Leonard Davis Institute of Health Economics. January 14, 2025. Accessed February 5, 2025. https://shorturl.at/wS2k9

WHO chief declares end to COVID-19 as a global health emergency. UN News. May 5, 2023. Accessed February 5, 2025. https://shorturl.at/TeSOt

Leading multidisciplinary oncology professionals look back at how the COVID-19 pandemic changed cancer care. 

Five-Year Impact of the COVID-19 Pandemic on the Oncology Community 

Strong Collaboration is Essential for Radiation Oncologists and Other Experts

As an expert in genitourinary cancers, he spoke about working with urologists as they are often the main “proceduralists” for diagnosing cancer, and medical oncologists as they would be the next step for the patient, after radiation fails them. When it comes to research, as Yu has a specific interest in that aspect of work, he collaborates with radiologists, pathologists, physicists, and health services researchers. All of this comes along with working with patients.

As Yu, professor in the Department of Radiation Oncology and Applied Sciences, leader of the Genitourinary Radiation Oncology Program at Dartmouth Hitchcock Medical Center, and radiation oncology editorial advisory board member of the Journal 

, stated, “radiation oncologists are at the end of the referral stream, so if you can’t collaborate with people or respond to referring physicians, then you’re not going to do very well in radiation oncology.”

As a radiation oncologist, James B. Yu, MD, MHS, FASTRO, works with urologists, medical oncologists, radiologists, pathologists, physicists, and health services researchers.