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The April issue of ONCOLOGY features a review on the use of AI in cancer care, plus a review on salivary antioxidants in oral cancer. 

April ONCOLOGY Publication

“The findings show that access to clinical trials alone is insufficient to overcome the inferior survival outcomes experienced by Black and Hispanic children with cancer,” according to lead study author Puja Umaretiya, MD, MS.

Despite uniformly planned treatment across frontline Children’s Oncology Group (COG) clinical trials, pediatric patients who were Black and Hispanic with high-risk neuroblastoma experienced worse overall survival (OS) outcomes, according to findings from a retrospective cohort study published in 

Among patients who were included in induction/consolidation trials, the 5-year OS rate was 47.2% and 61.3% for patients who were Hispanic and White, respectively (HR, 1.55; 95% CI, 1.11-2.15; 

 = .047). Per multivariate analysis adjusting for factors including 

amplification, tumor histology, and International Neuroblastoma Staging System (INSS) stage, investigators noted worse OS outcomes for Hispanic populations compared with those who were White (HR, 1.78; 95% CI, 1.25-2.53; 

Regarding patients who participated in post-consolidation setting trials, univariate analysis revealed significantly worse event-free survival (EFS) outcomes (

 = .01) for patients who were non-Hispanic Black (HR, 1.37; 95% CI, 1.05-1.79) and Hispanic (HR, 1.56; 95% CI, 1.14-2.15) compared with those who were White. When adjusting for tumor histology, INSS stage, and end-of-induction (EOI) disease response, multivariate analysis showed significantly worse EFS outcomes for patients who were Hispanic than those who were White (HR, 1.68; 95% CI, 1.14-2.47; 

Five-year OS rates were 67.7% for patients who were Black, 62.2% for patients who were Hispanic, and 75.7% for patients who were White. Compared with White populations, data showed significantly worse OS outcomes per univariate analysis (

 <.001) for patients who were Black (HR, 1.65; 95% CI, 1.23-2.22) and Hispanic (HR, 1.73; 95% CI, 1.21-2.47). Additionally, multivariate analysis adjusting for stage and EOI response revealed significantly shorter OS (

 = .009) for Black (HR, 1.54; 95% CI, 1.13-2.11) and Hispanic populations (HR, 1.63; 95% CI, 1.09-2.43) compared with patients who were White.

“The findings show that access to clinical trials alone is insufficient to overcome the inferior survival outcomes experienced by Black and Hispanic children with cancer,” lead study author Puja Umaretiya, MD, MS, assistant professor of Pediatrics in the Division of Hematology and Oncology and a member of the Harold C. Simmons Comprehensive Cancer Center at UT Southwestern Medical Center, stated in a press release on these findings.

 “While further work is needed to understand disparate survival outcomes, any efforts to improve outcomes for children with cancer will likely need to focus on health-related social needs, which are highly prevalent and may contribute to worse outcomes in Black and Hispanic children.”

Investigators of this retrospective study collected data from COG high-risk neuroblastoma trials conducted between January 1, 2007, and December 31, 2016; a data freeze occurred on June 30, 2021. The study included 2 patient cohorts: those who participated in an induction or consolidation setting trial, and those who participated in a post-consolidation setting trial.

The primary exposures of interest were race and ethnicity, with investigators categorizing patients as Hispanic; non-Hispanic Black; non-Hispanic other, which included those who were American Indian or Alaska Native, Asian, and Native Hawaiian or other Pacific Islander; and non-Hispanic White. The study’s primary end points were EFS and OS. Secondary end points were care delivery points believed to have mechanically impacted disparate survival outcomes, which included factors like induction delay, early trial withdrawal, relapse or progression as first event, and early phase trial enrollment among those experiencing relapse or progression.

The induction/consolidation cohort included 696 patients who were mostly White (n = 481) followed by Black (n = 109), Hispanic (n = 79), and other races (n = 27). Disproportionate household poverty exposure (

 <.001) was noted in patients who were Hispanic (58.2%) and Black (50.5%) compared with those who were White (25.2%).

Investigators included 935 patients in the post-consolidation cohort, with most being White (n = 662) followed by Black (n = 145), Hispanic (n = 87), and other races (n = 41). Correlations between race and ethnicity and poverty and rurality measures in the post-consolidation cohort mirrored those in the induction/consolidation cohort.

No significant differences in induction therapy duration or early trial withdrawal by race and ethnicity occurred. Additionally, investigators observed no significant differences by race and ethnicity for relapse and progression across the induction/consolidation and post-consolidation trials.

The 5-year cumulative incidence of death in induction/consolidation trials was 5.9%, 4.6%, 9.5%, and 16.2% for patients who were White, Black, Hispanic, and other races, respectively, which revealed significant differences by race and ethnicity (

 = .049). Across the post-consolidation trials, the 5-year cumulative incidence of death was 0.8%, 5.9%, 2.5%, and 2.4% in each racial and ethnic population (

OS from time of first relapse showed significant differences across racial and ethnic populations (

 = .04). No significant differences by race and ethnicity were noted for the characteristics of patients who relapsed or for enrollment on early phase trials after relapse.

“These data identify the need for studies focused in 2 areas. First, we need to be thoughtful about the data we collect on clinical trials to understand why marginalized groups do not experience the same outcomes,” Umaretiya stated.

 “Collecting more specific data, such as social determinants of health, may provide insight into the underlying causes. Simultaneously, we need to embed supportive care interventions for groups at risk for worse outcomes despite standardized therapies.”

Umaretiya PJ, Naranjo A, Zhang FF, et al. Racial and ethnic survival disparities among children with high-risk neuroblastoma: a Children’s Oncology Group report. 

. 2025;8(2):e2458531. doi:10.1001/jamanetworkopen.2024.58531

Differences in survival persist despite access to cancer clinical trials. News release. UT Southwestern Medical Center. April 29, 2025. Accessed May 1, 2025. https://tinyurl.com/2jyj9932

Articles

Clinical trial access alone appears to be insufficient in overcoming the worse survival outcomes observed in Black and Hispanic pediatric populations.

Data Show Racial/Ethnic Disparities in Pediatric Brain Cancer Survival

74 Lessons Learned From a Breast Surgery ERAS Program in an Oncologic Ambulatory Center

Enhanced Recovery After Surgery (ERAS) protocols have revolutionized surgical care, aiming to optimize patient outcomes and reduce recovery time. In the realm of breast surgery, ERAS implementation in an ambulatory setting presents unique challenges and opportunities. Key components of the ERAS protocol included multimodal pain management, early mobilization, postoperative nausea and vomiting (PONV) prophylaxis, and optimized fluid management. Several elements were updated over the years. This study aims to share our experiences and lessons learned from implementing an ERAS program for breast surgery in a high-volume ambulatory center.

We retrospectively reviewed 8721 patients who underwent breast surgery between January 2016 and December 2023. The cases were performed with an ERAS protocol. We collected data on surgical volume, intraoperative and postoperative opioids measured in morphine milligram equivalents (MME), length of stay, PONV, and postoperative complications, which included transfers to main hospital and 30-day urgent care center visits.

The volume increased 47% between 2016 and 2023. The implementation of the ERAS protocol resulted in significant reductions in intraoperative and postoperative opioid requirement (29% and 19%), PONV (41%), transfer (49%), 30-day urgent care center visits (43%), and 30-day readmissions (37%). There were no significant changes to length of stay.

The ERAS protocol implementation and improvement was associated with reduction in adverse outcomes despite substantial increase in the volume of cases. ERAS implementation in an ambulatory setting for breast surgery is feasible and can lead to substantial benefits for patients. However, challenges such as education, adherence to preoperative fasting guidelines, and managing unexpected complications remain. By addressing the unique challenges and tailoring the protocol to the ambulatory setting, optimal outcomes can be achieved. Future research should focus on further refining ERAS protocols and exploring innovative strategies to enhance patient outcomes.

The FDA refuses to file the sBLA for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with papillary disease without carcinoma in situ.

The FDA sent a refusal to file (RTF) letter to ImmunityBio regarding the 

supplemental biologics license application (sBLA)

 submitted in April 2025 for nogapendekin alfa inbakicept-pmln (Anktiva) in combination with Bacillus Calmette-Guérin (BCG) in the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with papillary disease without carcinoma in situ (CIS), according to a press release from the developer, ImmunityBio.

The RTF letter was received on May 2, 2025, and has been deemed “inconsistent” by the developer. The letter only impacts patients with papillary disease without CIS; the letter does not impact the 

 in patients with BCG-unresponsive NMIBC with papillary disease with CIS.

The developer claimed that leadership of the FDA gave unanimous guidance and encouragement to submit the sBLA at an in-person meeting in January 2025; the FDA’s Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, and Oncology Center of Excellence were all part of the meeting and similarly encouraged the submission of the sBLA.

An urgent meeting has already been requested by the developer to “resolve the inconsistencies between the directives provided at the January meeting and receipt of the RTF letter.”

“We are fully determined to work with the FDA as quickly as possible, including having already requested a Type A meeting, to explore the best path forward. We would also welcome an FDA Advisory Committee meeting as part of the regulatory process going forward,” said Patrick Soon-Shiong, MD, founder, executive chairman, and global chief scientific and medical officer at ImmunityBio, in the press release.

 “We presented our data at the recent 2025 American Urological Association (AUA) meeting and [nogapendekin alfa inbakicept plus] BCG was considered best in class and best in disease by the thought leaders in attendance, when compared to all the therapies currently approved or in development.”

Results supporting nogapendekin alfa inbakicept came from the single-arm, open-label, phase 2/3 QUILT-3.032 trial (NCT03022825), which evaluated the agent in combination with BCG in patients with BCG-unresponsive NMIBC.

At 36 months, more than 82% of patients with papillary disease without CIS and 84% of patients with papillary disease and CIS had cystectomy avoidance. In patients without CIS and patients with CIS, disease-specific survival was 99% and 100%, respectively, at 12 months, and 96% and 99%, respectively, at 36 months.

Additionally, the median disease-free survival among those without CIS was 19.3 months (95% CI, 7.4-not reached).

 The progression-free survival rate at 12 months was 97.1% (95% CI, 88.8%-99.3%); at 18 months, it was 94.8% (95% CI, 84.3%-98.3%); and at 24 months, it was 88.8% (95% CI. 74.1%-95.4%). The overall survival rate at 12 months was 98.6% (95% CI, 90.2%-99.8%); at 18 months, it was 94.3% (95% CI, 82.9%-98.1%); and at 24 months, it was 91.7% (95% CI, 79.0%-96.9%).

Rachel Sherman, MD, MPH, the former FDA principal deputy commissioner, added in the press release, “I actively participated in the January 2025 meeting at which the leadership of the agency present at that meeting unanimously supported and encouraged ImmunityBio to submit results from the single arm trial, QUILT 3.032, as an sBLA because of the high risk of progression and metastasis these patients with BCG unresponsiveness [have]. The consensus was reached by all present, including me, because of the lack of satisfactory alternatives in this desperately ill population at high-risk of losing their bladder—a life-threatening and life-changing procedure.”

Sherman also added, “Furthermore, it is incomprehensible to me that the FDA refuses to file a [sBLA], stating the study is not sufficient to support a regulatory review, when it has already approved a product based on that very same study in essentially the same indication and population….These patients [have] a disease with a high risk of morbidity and mortality in the very short term; no delay should be tolerated.”

Cohort B, the cohort of patients with papillary disease without CIS, included a total of 80 patients. All patients in the cohort received nogapendekin alfa inbakicept plus BCG via a urinary catheter for 6 consecutive weeks in the initial induction treatment period.

 After the first assessment, patients received either a 3-week maintenance course or a 6-week re-induction course at month 3. Those who were eligible received maintenance treatment at months 6, 9, 12, and 18, and then those who were eligible had the option to receive maintenance treatment at months 24, 30, and 36.

Eligible patients in the trial were 18 years or older with histologic confirmation of NMIBC of the transitional cell carcinoma high-grade subtype and histologic confirmation of presence of BCG-unresponsive CIS or BCG-unresponsive high-grade Ta or T1 disease.

 BCG-unresponsive disease was defined as persistent or recurrent CIS with or without Ta/T1 disease within 12 months of receiving adequate BCG; recurrent high-grade Ta/T1 disease within 6 months of completing adequate BCG; or T1 high-grade disease at first evaluation following induction BCG alone.

Cohort B’s primary end point was the disease-free rate at 12 months. Secondary end points included disease-free survival, disease-specific survival, time to cystectomy, and safety.

In cohorts A and B combined, 86% of patients experienced at least 1 treatment-emergent adverse event (TEAE) of grade 1 or 2; of grade 3 TEAEs, 20% experienced at least 1.

 The most common grade 1/2 TEAEs were dysuria (30%), pollakiuria (25%), and hematuria (25%).

“The agency must explain the confounding inconsistency of approving [nogapendekin alfa inbakicept plus] BCG for patients with papillary with CIS disease, while refusing to file the sBLA for patients with papillary without CIS disease—even though both groups were part of the same trial, in the same high-risk population of BCG-unresponsive [NMIBC],” Soon-Shiong concluded.

 “On behalf of patients facing a potential loss of a vital organ and high risk of progression of disease, I urge the agency to reconsider and act now.”

ImmunityBio requests an urgent meeting with FDA to address the change in the agency’s unambiguous guidance on Jan 2025 to submit a sBLA for NMIBC BCG unresponsive papillary disease, following an inconsistent refusal to file letter on May 2, 2025. News release. ImmunityBio. May 5, 2025. Accessed May 5, 2025. https://tinyurl.com/mrxe54vp

ImmunityBio announces FDA submissions of supplemental BLA for NMIBC papillary disease and for expanded access of ANKTIVA® to treat lymphopenia. News release. ImmunityBio. April 15, 2025. Accessed May 5, 2025. https://tinyurl.com/4atzxwjv

FDA approves nogapendekin alfa inbakicept-pmln for BCG-unresponsive non-muscle invasive bladder cancer. News release. FDA. April 22, 2024. Accessed May 5, 2025. https://tinyurl.com/b8d9672c

Chamie K, Chang SS, Kramolowsky E, et al. IL-15 superagonist NAI in BCG-unresponsive non–muscle-invasive bladder cancer. 

QUILT-3.032: A multicenter clinical trial of intravesical Bacillus Calmette-Guerin (BCG) in combination with ALT-803 (N-803) in patients With BCG unresponsive high grade non-muscle invasive bladder cancer. ClinicalTrials.gov. Updated April 13, 2025. Accessed May 5, 2025. https://tinyurl.com/5a5vetsz

The FDA refuses to file the sBLA for nogapendekin alfa inbakicept plus BCG in BCG-unresponsive NMIBC with papillary disease without carcinoma in situ. 

FDA Issues Refusal to File Letter for Nogapendekin Alfa Inbakicept in NMIBC

Eric Winer, MD, the director of the Yale Cancer Center, chair of the association board for the ASCO, and an investigator on the survey. 

 published a survey that revealed a 14% increase in the rate of oncologists who experienced workplace burnout, from 2013 to 2023 (

 While there are certainly a great deal of global issues that could have contributed to this, such as the COVID-19 pandemic or changes in technology, there were also many contributing factors that are much smaller in scale.

CancerNetwork® spoke with Eric Winer, MD, one of the authors of the study, about the current state of oncologist burnout, what can be done to fix it, and how it currently affects the workforce.

Among the causes identified in the paper were the use of electronic health records, staffing levels, payer authorizations, hours worked, and age. Beyond that, there was also a correlation between being a caregiver to someone at home and workplace burnout (

<.05). Winer also emphasized that many oncologists have to do tasks, such as administrative ones, that take away from the patient care aspect, which may lead to increased feelings of burnout or fatigue.


Winer is the director of the Yale Cancer Center, president and physician-in-chief at Smilow Cancer Hospital, deputy dean for Cancer Research, Alfred Gilman Professor of Pharmacology, professor of medicine at Yale School of Medicine, and chair of the association board for the American Society of Clinical Oncology (ASCO).

CancerNetwork: What is workplace burnout?

 Workplace burnout is something that is not unique to the medical profession, and there’s a [lot of] literature on burnout in a variety of different situations. When we talk about burnout related to medicine and related to oncology, we’re talking about a syndrome that involves fatigue, some element of depersonalization, a lack of interest in continuing to pursue work, feeling stressed, feeling emotionally exhausted, and oftentimes feeling a lack of empathy for the people one takes care of, with increasingly negative attitudes about work in general.

People could suspect that oncology would be an area where there would be a lot of burnout. For many oncologists, there’s less burnout, and what keeps many of us from being burnt out is the mission-driven nature of the work. I don’t have to go home and worry about whether I gave enough to the world today. There are professions where people don’t have that luxury, and the work I do feels very meaningful.

Why might oncologist burnout have increased from 2013 to 2024?

There are a number of factors. [First], since I referred to burnout across the board and in society, some of this is a little bit of a societal issue because you hear more and more people talking about burnout. You hear more people talking about wanting to achieve a work-life balance, and maybe that’s a little more difficult in medicine than in [other] places, which can lead to burnout. The COVID-19 pandemic was stressful. While, on the one hand, early in the pandemic, everyone felt extraordinarily mission-driven as if they were in a battleground, and while that tends to bring people together, there’s fatigue associated with that. A lot of [clinicians] felt that they couldn’t practice [medicine] the way they would like to practice; they had to make decisions, particularly early on, about treatments that needed to be delayed or not given.

Although telehealth is a great thing when used properly, telehealth also puts a barrier between the doctor and the patient. I will confess to you that I don’t like telehealth. I’m willing to do it occasionally, but I like sitting face-to-face with a patient, and without that, it’s a different interaction. Finally, in the last 10 to 12 years, we’ve seen this proliferation of tasks that many physicians never thought they would have to do: excessive documentation, [spending] all this time in front of screens instead of in front of patients, and insurance authorizations. There are just a lot of pieces of our jobs that don’t feel like they’re mission driven.

The survey also found that 20% of oncologists planned to reduce their hours. How might that affect the workforce?

We have a workforce problem, which is part of the reason why we need to embrace [nurse practitioners] and [physician assistants], or [advanced practice providers]. We need to incorporate them into the care model. There are more oncologists who are nearing retirement age; I’m told, based on ASCO [research], that 23% of oncologists say they’re nearing retirement age, whereas only 14% are under the age of 40.

 Now, I don’t know that those 2 groups are equal, so there may be people in their late 50s who are going to work for another decade who say they’re nearing retirement age. We are concerned about the fact that, if anything, the oncology workforce needs to expand, because people are living longer with active cancer, and they need care—there’s that much more we can do for people. There’s not necessarily an increase in the number of people going into oncology.

When I was a young breast cancer doctor, we didn’t have a lot of treatments. Everything was much simpler because there were only a few choices, and because we only had a few choices, people didn’t live as long when they had incurable cancer. Now, there are people who live for 5, 10, 15, and 20 years with active cancer. Our practices get filled up, not by new patients, but by all the people who need care and that we’re taking care of.

Some of the leading stressors have to do with administrative tasks. How can oncologists better deal with them?

This is where the health system you work in is critical because there needs to be people in the system who are attending to a lot of these issues [such as staffing levels or payer authorizations] so that it doesn’t all fall to the doctor. I cannot overestimate how important this is. We need to have people in place. We need to restructure our teams to make sure that they’re efficient. It’s possible to get rid of a lot of those stressors by having the right team put into place.

I don’t think that’s something that is necessarily entirely under the control of the oncologist. Very few oncologists these days are in [1 to 4] person practices. Most people are either at an academic center, or they’re in a site affiliated with an academic center, or they’re in very large oncology groups. It’s the system that has to work on behalf of the oncologist.

How have you dealt with/managed the times you’ve felt burnout?

Everybody’s different, but I don’t feel like I’ve ever been particularly burnt out for a long period of time, meaning more than about a day. To this day, patients and clinical care drive everything that I do, and that helps me. Everybody’s got to find their own sweet spot, and I don’t pretend to think that what makes me run well, what makes me tick, is what’s good for someone else. The one thing that doesn’t work is when people aren’t comfortable with who they are and what they’re doing. You have to ultimately be comfortable with the mix of work you do during the week.

The administrative burdens of clinical practice are crushing, and we have to take significant steps to make sure that those burdens do not overwhelm all of us. I’ve been protected from a lot of them for a long time, but I see those burdens as [increasing].

What should other oncologists take away from this conversation?

[Oncology] is great for just so many reasons, and it’s greater than it ever was. The patient care is extraordinary; there are wonderful things you can do for patients. Even when we’re not successful in saving someone’s life, the way we take care of people matters. As a part of the job, that’s also something that can be very fulfilling. The other piece of this is that you get to see science in action. Most of the treatments we have today didn’t exist—even in anyone’s imagination—30 years ago. We’ve seen this steady improvement over time, and I don’t know that there are too many other fields like that. Certainly, HIV, which went from being an almost uniformly fatal condition to one that’s treatable and that people can live completely normal lives with, is a good example. I hope people take from this the fact that [oncology is] a great field.

Schenkel C, Levit LA, Kirkwood K, et al. State of professional well-being, satisfaction, and career plans among US oncologists in 2023. 

Published online January 29, 2025. doi:10.1200/OA.24.00010

2023 snapshot: state of the oncology workforce in America. 

. 2025;21(3):438. doi:10.1200/OP.24.00262

A recent survey showed that 20% of oncologists planned to reduce their hours in the next 12 months, as workplace burnout among them has increased.  

Workplace Burnout Among Oncologists Has Risen: What Can be Done?

A median local progression-free survival of 13.3 months was observed following completion of radiation in patients with locally advanced or borderline resectable pancreatic cancer.

JNJ-1900 (NBTXR3) demonstrated favorable safety, feasibility, and early efficacy outcomes in a small cohort of patients with locally advanced or borderline resectable pancreatic ductal adenocarcinoma (PDAC), according to a news release from the drug’s developer, Nanobiotix.

Data from a phase 1 trial (NCT04484909) presented at the 2025 Annual Meeting of the European Society of Radiation Oncology revealed that JNJ-1900 showed injection feasibility in 22 patients treated with the agent for locally advanced or borderline resectable pancreatic cancer. Additionally, efficacy results showed that the median overall survival (OS) among this patient population was 23 months from diagnosis (95% CI, 17-not reached [NR]). A historical review of 144 patients with locally advanced pancreatic cancer at The University of Texas MD Anderson Cancer Center revealed that this group experienced a median OS of 19.2 months after receiving treatment with induction chemotherapy followed by radiotherapy with or without maintenance chemotherapy, the standard of care (SOC).

Further data showed that a median local progression-free survival (PFS) of 13.3 months was observed following completion of radiation. Notably, 2 patients with locally advanced pancreatic cancer achieved an R0 surgical resection.

“Patients with locally advanced or borderline resectable pancreatic cancer [have] a particularly urgent unmet need for therapeutic innovation that can provide a meaningful survival benefit with an acceptable safety profile,” Eugene J. Koay, MD, PhD, associate professor of Gastrointestinal Radiation Oncology at MD Anderson, said in the news release.

 “We are encouraged by the results from the completed cohorts and look forward to the continued evaluation of JNJ-1900 in combination with standard-of-care chemoradiation after induction chemotherapy.”

Patients in the phase 1 study with either locally advanced (n = 20) or borderline resectable (n = 2) pancreatic cancer were treated with intratumoral NBTXR3 on day 1 of treatment following induction chemotherapy. Between days 15 and 43 of treatment and in the absence of progressive disease or unacceptable toxicity, patients underwent 15 fractions of radiation therapy.

The primary end point of the phase 1 study was to find the recommended phase 2 dose of radiotherapy-activated NBTXR3. Secondary end points included safety, injection feasibility, anti-tumor responses, and time-to-event outcomes. Exploratory end points included pharmacokinetics, resectability conversion rates, surgical outcomes, and biomarkers of response.

Exploratory biomarker analyses data showed that among 20 patients who had available circulating tumor mutational burden (TMB) data, 40% exhibited increased TMB. An association between increased circulating TMB and improved local PFS and OS was observed. Furthermore, normalization of CA19-9, a surrogate for OS benefit, was observed in 59% of patients. A historical review of 243 patients with locally advanced pancreatic cancer at MD Anderson revealed that normalization of CA19-9 was observed in 17% of patients treated with the standard-of-care treatment.

“Our collaboration with MD Anderson has always been driven by a shared commitment to exploring bold new approaches for patients with high unmet need,” Louis Kayitalire, MD, chief medical officer at Nanobiotix, expressed in the news release.

 “Given the poor survival rates in [locally advanced] and [borderline resectable pancreatic cancer], the results from this phase 1 study give us confidence in the potential of JNJ-1900 to serve as a meaningful addition to the treatment landscape.”

JNJ-1900 was developed as an oncologic agent composed of functionalized hafnium oxide nanoparticles injected intratumorally and activated by radiotherapy. Its mechanism of action is designed to induce tumor cell death when activated by radiotherapy, triggering adaptive immune response and long-term anti-cancer memory.

The FDA granted clearance for an expanded study that includes a new cohort combining JNJ-1900 with the standard-of-care concurrent chemoradiation following induction chemotherapy. The study has begun treatment for its first patient in the new cohort, and recruitment is currently ongoing.

Nanobiotix announces full results from completed phase 1 study evaluating JNJ-1900 (NBTXR3) in pancreatic cancer. News release. NANOBIOTIX. May 5, 2025. Accessed May 5, 2025. https://tinyurl.com/4rjst9bk

NBTXR3 activated by radiation therapy for the treatment of locally advanced or borderline-resectable pancreatic cancer. ClinicalTrials.gov. Updated April 9, 2025. Accessed May 5, 2025. https://tinyurl.com/4xymfmpc

Among 20 patients with advanced pancreatic cancer and available circulating tumor mutational burden data, 40% exhibited increased tumor mutational burden.

JNJ-1900 Demonstrates Safety, Feasibility in Advanced Pancreatic Cancer

Divarasib Combo Appears “Promising” in Pretreated KRAS G12C+ NSCLC

Luo AACR 1

2025 American Association for Cancer Research Annual Meeting,

 Jia Luo, MD, spoke about her phase 1 study (NCT04449874) assessing the novel KRAS G12C inhibitor divarasib (GDC-6036) in combination with the SHP2 inhibitor migoprotafib (GDC-1971) for patients with 

G12C–positive non–small cell lung cancer (NSCLC).

According to Luo, a thoracic oncologist at Dana-Farber Cancer Institute and an instructor in medicine at Harvard Medical School, the divarasib combination particularly demonstrated “promising” activity in a cohort of patients who received prior KRAS G12C inhibitors vs those who had no previous exposure to these agents. Additionally, future research will focus on the biomarkers associated with the pretreated cohort to further elucidate the outcomes of patients who respond to divarasib/migoprotafib.

In terms of safety, we did see that the SHP2 inhibitor, even though it had better preclinical properties, still had some challenges with tolerability. We reported the 400 mg of divarasib, which is the dose carried forward for the pivotal study, and various doses of the SHP2 inhibitor: 20 mg and 40 mg. The 40-mg [dose] was a little more difficult to handle, and there were some dose holds, decreases, and pauses with that drug in terms of efficacy. There were 2 cohorts. There were individuals who’d never seen a KRAS G12C inhibitor and had [NSCLC. They] received first-line treatment, progressed, and then were assigned to this arm of the trial. Then there was another cohort where individuals had prior [treatment with] mostly sotorasib [Lumakras], adagrasib [Krazati], [JDQ443], as well as divarasib. [These were] prior KRAS G12C inhibitor–experienced patients.

In the cohort of individuals who’d never seen a KRAS G12C inhibitor, the initial objective response rate was around the same as what we see for divarasib [monotherapy]. It was less clear, in this early look at 40-some patients, that there was an obvious signal to move this forward. However, in the individuals who had a prior KRAS G12C inhibitor, we did see some interesting responses. It’s early to say what the contribution of components is, but it is promising that, even though they had a prior KRAS G12C inhibitor and have progressed before being assigned to this clinical trial, we see some activity in this combination.

Future work will be interrogating the biomarkers of these patients who had experienced KRAS G12C inhibitors in the past and are now responding to this combination. We have some early circulating tumor DNA [ctDNA] data that suggest good outcomes, but [there is] much more to come. All patients had samples, including ctDNA, that were sent for a large panel that remains to be analyzed.

Luo J, Sacher A, Santoro A, et al. Divarasib plus migoprotafib combination treatment in patients with KRAS G12C-positive non-small cell lung cancer (NSCLC). Abstract presented at: 2025 American Association for Cancer Research Annual Meeting; April 25-30, 2025; Chicago, IL. Abstract CT022.

Videos

Ongoing ctDNA analysis may elucidate outcomes associated with divarasib plus migoprotafib for those with KRAS G12C–positive NSCLC.