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The September issue of ONCOLOGY features a rare case study on glioblastoma, discussions on end-of-life care, and insights into the field of pediatric oncology. 

September ONCOLOGY Publication

Data support the use of radioligand therapy in combination with androgen receptor pathway inhibitors to optimize prostate cancer outcomes.

Fitting Radioligands Into the Metastatic Prostate Cancer Treatment Paradigm

For Praful Ravi, MB, BChir, MRCP, radioligand therapies (RLTs) are chess pieces on a treatment chessboard that includes androgen receptor pathway inhibitors (ARPIs) and taxane-based chemotherapy.

In an interview with CancerNetwork®, Ravi, medical oncologist at the Lank Center for Genitourinary Oncology at the Dana-Farber Cancer Institute, discussed how his team integrates RLTs into clinical practice for metastatic prostate cancer, as well as any evidence supporting their use in combination therapies for the disease.

He began by outlining the current landscape for prostate cancer treatment, which is comprised of RLTs, ARPIs, and taxane-based chemotherapy. For patients with hormone-sensitive disease, first-line care primarily consists of androgen deprivation therapy (ADT) with ARPIs with or without chemotherapy doublet or triplet therapy, with RLTs considered in the second-line setting. Furthermore, he explained that multiple features affect whether he uses an RLT alone or as part of a combination, including disease avidity, intensity, and expression.

Ravi highlighted post-hoc findings from the phase 3 VISION trial (NCT03511664), which revealed that patients with metastatic prostate cancer who were treated with an ARPI in combination with 

Lu-PSMA-617, an RLT, had comparatively better outcomes vs 

 Data from the phase 2 ENZA-p trial (NCT04419402) further displayed that ARPIs might upregulate PSMA expression among these patients, although the data were weak.

In his own practice, Ravi continues the use of ARPIs when he initiates RLT use to improve outcomes in the absence of adverse effects or financial toxicity. He concluded by saying that ongoing clinical trials are evaluating RLT-based combinations for prostate cancer, including at Dana-Farber, to bolster outcomes for these patients.

I view radioligand therapy as a chess piece on the chessboard. I tell patients that, for prostate cancer, we have 3 therapy buckets. We have the hormonal agents—ARPIs; we have taxanes—chemotherapy; and then we have the RLTs. We think about what the right time is to use each one. Right now, in the hormone-sensitive setting, there is no approved indication for RLT. That space is really ADT plus ARPI, or ADT plus ARPI plus chemotherapy—the doublet or triplet approach. Generally, in that progression after first-line therapy for hormone-sensitive diseases is when I start thinking about RLT. I use features such as the extent of avid disease, whether the patient's symptomatic or not, how high the expression is, and how intense the target is––those types of features decide if now is the right time, post-ARPI or post-triplet, to use RLT vs another agent or to think about a clinical trial, in terms of combinations.

Lu-PSMA-617, at least––was studied, it was done in the [phase 3] VISION trial, either alone or patients could be on an ARPI with it, and in [the phase 3 PSMAfore trial [NCT04689828], it was done alone. Generally speaking, we tend to prescribe it alone, but there is increasing data that [using] it in combination with an ARPI might improve the outcomes further. There are some weak data that an ARPI might upregulate [prostate-specific membrane antigen (PSMA)] expression and therefore enhance the response to PSMA-targeted therapy, or PSMA RLT. This was seen in the ENZA-p study. There's also post-hoc analysis from the VISION trial showing that patients who had a concurrent ARPI with [

Lu-PSMA-617] did slightly better than those who did not.

In general, if I have a patient who is on an ARPI already, and I am thinking about moving to [

Lu-PSMA-617], I think about continuing that, just in case it might improve the outcomes, as long as it's not causing extra [adverse] effects [or] is not financially toxic to the patient. We start thinking about combinations. There's increasing interest and study of combinations with RLT, ongoing clinical trials, including things that we are doing at our own institution, to look at this, and to see how we can optimize 

Armstrong AJ, Sartor O, de Bono J, et al. Association of declining prostate-specific antigen levels with clinical outcomes in patients with metastatic castration-resistant prostate cancer receiving [

Lu]Lu-PSMA-617 in the phase 3 VISION trial. 

 2024;86(6):552-562. doi:10.1016/j.eururo.2024.08.021

Emmett L, Subramaniam S, Crumbaker M, et al. [177Lu]Lu-PSMA-617 plus enzalutamide in patients with metastatic castration-resistant prostate cancer (ENZA-p): an open-label, multicentre, randomised, phase 2 trial. 

 2024;25(5):563-571. doi:10.1016/S1470-2045(24)00135-9

Videos

SC Mosunetuzumab Will Be Accessible for MZL Care in Community Settings

Society of Hematologic Oncology 2025 Annual Meeting

, updated results from the phase 2 MorningSun trial (NCT02500407) showed that subcutaneous single-agent mosunetuzumab-axgb (Lunsumio) achieved meaningful, durable responses and was tolerable for patients with previously untreated marginal zone lymphoma (MZL).

As a basket trial, MorningSun was born after subcutaneous mosunetuzumab was proven to be noninferior to the intravenous formulation. Of the various disease types included in the trial, there is an unmet need for patients with MZL, as chemoimmunotherapy combinations are the current standard, and researchers seek more improvements.

Notably, mosunetuzumab is FDA-approved as an intravenous formulation in the third-line treatment of patients with relapsed/refractory follicular lymphoma.

Tara M. Graff, DO, MS, the presenting author and director of Clinical Research at Mission Cancer and Blood, spoke with CancerNetwork® about these results and their implications on the MZL treatment paradigm.

What was the rationale for evaluating mosunetuzumab in MZL?

The rationale backing up the MorningSun trial is that, currently, mosunetuzumab is a CD3/CD20 bispecific antibody approved in relapsed/refractory follicular lymphoma in the third-line setting, and it’s approved in an [intravenous (IV)] formulation—there was a trial done that looked at studying mosunetuzumab in a [subcutaneous] formulation compared with IV to make sure that it was not inferior, and it proved not to be.

 Then, with that, the MorningSun trial was born.

The MorningSun trial is basket trial looking at the mosunetuzumab subcutaneous formulation across a number of different disease subtypes, [including] follicular lymphoma, both low tumor burden and high tumor burden; you have MZL and all subtypes of MZL; and you have diffuse large B-cell lymphoma for the elderly unfit population. Those are all frontline treatments, so none of those patients have seen any therapy before.

You also have patients with relapsed/refractory mantle cell lymphoma, transformed lymphoma, and then Richter’s transformation. Specifically, there’s an unmet need for our patients with frontline [MZL]. Typically, we use a combination of chemoimmunotherapy, but we want to improve on that in the same way we are improving on other types of lymphoma. That [informed] that cohort in MorningSun.

What are the immediate clinical implications of these findings?

[Mosunetuzumab offers] a chemotherapy-free option for these patients. Nobody wants chemotherapy, and I’m not saying that chemotherapy is bad, but it’s just that we’ve advanced. We’ve advanced in diffuse large B-cell lymphoma and follicular lymphoma, and we’re making advancements all the time to be chemotherapy-free or use the least amount of chemotherapy as possible. [MZL], in terms of the indolent lymphomas, gets forgotten about sometimes. This is offering those patients a tolerable and efficacious [therapy], and it’s a finite amount of therapy; it’s 17 cycles, and then it’s done. They’re not on treatment consistently or constantly; it’s not “treat to progression”. It is 17 cycles, and then you’re done. They can stay home. They don’t have to go to the hospital. They don’t have to travel to another center. This was able to be done as an outpatient in community sites.

What will happen when it gets approved? Not every community site is going to be doing bispecific [antibodies]. We’re trying to get more availability of bispecific [antibodies] in the community. Hopefully, this therapy will make its way into as many sites as safely as possible, so we’ll see how it turns out.

Burke JM, Tun AM, Villasboas J, et al. MorningSun: open-label phase II trial of the efficacy and safety of subcutaneous mosunetuzumab as frontline treatment in symptomatic patients with marginal zone lymphoma. Presented at the Society of Hematologic Oncology 2025 Annual Meeting; September 3-6, 2025; Houston, TX. Abstract IBCL-1494.

FDA grants accelerated approval to mosunetuzumab-axgb for relapsed or refractory follicular lymphoma. FDA. December 22, 2022. Accessed September 17, 2025. https://tinyurl.com/4munzr95

The subcutaneous formulation of mosunetuzumab will require 17 cycles of therapy, without any maintenance, and can be done in outpatient settings. 

D-VRd had a 72% chance of providing superior PFS outcomes vs isatuximab plus VRd in patients with transplant-ineligible NDMM.

Daratumumab (Darzalex; D) plus bortezomib (Velcade; V), lenalidomide (Revlimid; R), and dexamethasone (d; D-VRd) demonstrated the highest probability of attaining the best progression-free survival (PFS), overall survival (OS), and minimal residual disease (MRD)-negative complete response (CR) rate outcomes compared with other standard of care regimens reflected in clinical guidelines for patients with transplant-ineligible newly-diagnosed multiple myeloma. These results were presented in a systematic literature review and network meta-analysis shared in a poster at the 

When comparing D-VRd with other regimens for PFS, there was a 72% chance it was superior vs isatuximab (Sarclisa) plus VRd (Isa-VRD; HR, 0.85), an 88% chance it was superior vs DRd (HR, 0.71), and a 91% chance it was greater than daratumumab, bortezomib, melphalan (Alkeran), and prednisone (DVMP; HR, 0.63). There was a 100% probability that D-VRd was favorable vs the remaining 8 combinations, ranging from VRd (HR, 0.51) to melphalan and prednisone (HR, 0.15). PFS heterogeneity was moderate (I

, 45.8%; 95% credible intervals [CrIs0, 0.0%-82.0%).

When conducting a similar comparison for OS, there was a 66% chance D-VRd was favorable vs Isa-VRd (HR, 0.85), a 79% chance it was superior vs DRd (HR, 0.77), a 97% chance it was superior vs VRd (HR, 0.66), an 85% chance it was superior vs DVMP (HR, 0.58), and a 99% chance it was superior vs continuous Rd (HR, 0.51). There was a 100% probability that D plus VRd was favorable vs the remaining 5 combinations, which ranged from melphalan, prednisone, and thalidomide (HR, 0.39) to melphalan and prednisone (HR, 0.26). OS heterogeneity was low (I

In the analysis comparing D-VRd with other regimens for MRD-negative CR rate, there was an 81% probability that it was favorable vs Isa-VRd (OR, 1.31), and a 100% probability that it was favorable vs VRd (OR, 2.37).

“These comparative efficacy data may inform treatment selection for maximum benefit in the [transplant-ineligible newly diagnosed multiple myeloma] population; findings should be considered alongside differences in trial timing and baseline characteristics,” wrote lead study author Saad Z. Usmani, MD, MBA, FACP, FASCO, chief of Myeloma Service at Memorial Sloan Kettering Cancer Center, with coauthors in the presentation.

From November 30, 2020, to August 6, 2024, a systematic literature review was conducted to identify large randomized controlled trials that published efficacy and safety outcomes in the transplant-ineligible newly diagnosed multiple myeloma population. When trials that used both transplant-eligible and transplant-ineligible patients were included, subgroup data for patients who were transplant-eligible were used, if available.

The regimens included in the analysis were endorsed by the American Society of Clinical Oncology/Clinical Care Options, NCCN, European Hematology Association/European Society of Medical Oncology, or European Myeloma Network.

Specifically, the regimens included in the network meta-analysis base case were: cyclophosphamide, thalidomide, and dexamethasone; D plus Rd; DVMP; Isa-VRd; carfilzomib (Kyprolis) plus Rd; melphalan and prednisone; melphalan, prednisone, and thalidomide; Rd; Vd; VMP; and VRd.

A total of 134 records were used for 95 unique studies; 90 were from databases, 43 were from other sources, and 1 was results from the phase 3 CEPHEUS trial (NCT03652064). Of note, 14 randomized controlled trials were included in the final PFS/OS evidence networks, and 14 each reported OS and PFS.

The analyzed outcomes included PFS, OS, and MRD negativity with CR.

Regarding limitations, comparability may have been limited by differences in trial timing, as some regimens reflected outdated clinical practice. Further, some guideline-recommended regimens were excluded from the network due to insufficient connectivity.

Usmani SV, Facon T, Hungria V, et al. Daratumumab-bortezomib-lenalidomide-dexamethasone vs contemporary treatment alternatives in transplant-ineligible patients with newly diagnosed multiple myeloma: results of a systematic literature review and network meta-analysis. Presented at the Society of Hematologic Oncology 2025 Annual Meeting; September 2-5, 2025; Houston, TX. Poster MM-1193.

Articles

Which Therapy Has the Best Efficacy in Transplant-Ineligible NDMM?

Twice-Daily Chemoradiotherapy Boosts Survival in Limited-Stage SCLC

Gui 2

 about key efficacy and safety findings from a meta-analysis of prospective trials assessing twice-daily and once-daily chemoradiotherapy (CRT) among patients with limited-stage small cell lung cancer (LS-SCLC). He and colleagues presented results from this analysis in a poster session at the 

2025 American Society of Radiation Oncology (ASTRO) Annual Meeting.

Across 8 trials including approximately 3000 patients, Gui, resident physician in the Department of Radiation Medicine at Northwell Health Cancer Institute, noted that survival improved with a twice-daily radiotherapy schedule, even when combining CRT with immunotherapy. Furthermore, there appeared to be no differences in high-grade toxicities of interest when comparing the twice-daily and once-daily regimens.

Data from the poster revealed a 13% improvement in 2-year overall survival (OS) with twice-daily CRT vs a once-daily regimen (RR, 1.13; 95% CI, 1.06-1.21). Additionally, in 3 trials evaluating immunotherapy plus CRT, the 2-year OS rate improved by 25% with the twice-daily schedule (RR, 1.25; 95% CI, 1.13-1.39).

Additional data highlighted that significantly less leukocyte depletion (OR, 0.70; 95% CI, 0.52-0.94) and lymphocyte depletion (OR, 0.39; 95% CI, 0.19-0.78) occurred with twice-daily CRT vs once-daily treatment. Across all evaluable studies, investigators observed no differences in grade 3 or higher esophagitis or pneumonitis with the use of twice-daily or once-daily CRT. Looking ahead, Gui and co-authors noted a need for head-to-head randomized trials comparing once-daily and twice-daily CRT with consolidation immune checkpoint inhibitors to validate these findings.

Eight trials comprising nearly 3000 patients were included for this meta-analysis.We found that twice-daily radiotherapy significantly improved 2-year OS by 13% compared to the once-daily regimen. More importantly, in the subgroup analysis of 3 trials incorporating immunotherapy, 2-year OS was 25% higher with twice-daily radiotherapy.

Across all trials, there were no differences in grade 3 or higher esophagitis or pneumonitis. Also, in the 2 trials that reported lymphocyte counts, twice-daily thoracic radiotherapy was associated with significantly less leukocyte depletion and lymphocyte depletion.

Gui B, Akerman M, Sekari J, Plann-Curley B, Parashar B. Should we return to old school in a new era? A meta-analysis of twice daily vs. once daily concurrent chemoradiotherapy for limited-stage small cell lung cancer. Presented at the 2025 American Society of Radiation Oncology (ASTRO) Annual Meeting; September 27 – October 1, 2025; San Francisco, CA.

Twice-daily thoracic radiotherapy appeared to confer less leukocyte and lymphocyte depletion compared with once-daily radiation in LS-SCLC.

Supporting data for the BLA came from the phase 1/2 CADENZA trial (NCT03386513), in which investigators evaluated treatment with pivekimab sunirine monotherapy for patients with CD123-positive hematologic malignancies, including BPDCN.

Developers at AbbVie have submitted a biologics license application (BLA) to the FDA seeking the approval of pivekimab sunirine as a treatment for patients with blastic plasmacytoid dendritic cell neoplasms (BPDCN), according to a press release from the developers.

BPDCN is a rare, aggressive blood cancer with features that bear resemblance to lymphoma and leukemia. Those who have BPDCN typically present with skin lesions, with disease often spreading to the bone marrow, central nervous system, and lymph nodes. According to the developers, frontline therapeutic options for this population include intensive chemotherapy followed by stem cell transplant, necessitating additional treatment strategies for patients with newly diagnosed and relapsed/refractory disease.

Developers engineered pivekimab sunirine as an investigational CD123-directed antibody drug conjugate (ADC) for use in BPDCN and other hematologic malignancies like acute myeloid leukemia. Given the overexpression of CD123 in BPDCN, developers hypothesized that the protein would be an ideal therapeutic target in this population.

“Meaningful innovations in cancer research and treatment are happening every day. It is important that these innovations reach patients who desperately need them, including those with rare cancers who have limited options,” Roopal Thakkar, executive vice president of Research and Development and chief scientific officer at AbbVie, stated in the press release.

 “We look forward to next steps in the regulatory process for our latest ADC, our first ADC in blood cancer, and how it may advance treatment for those living with BPDCN.”

Supporting data for the BLA came from the phase 1/2 CADENZA trial (NCT03386513), in which investigators evaluated treatment with pivekimab sunirine monotherapy for patients with CD123-positive hematologic malignancies, including BPDCN. Investigators previously presented data from the CADENZA trial at the 

2025 American Society of Clinical Oncology (ASCO) Annual Meeting

Treatment with pivekimab sunirine produced a complete response (CR) and CR with minimal skin abnormality (CRc) rate of 75% (95% CI, 50.9%-91.3%) and an overall response rate (ORR) of 80% (95% CI, 56.3%-94.3%) among patients with frontline de novo BPDCN (n = 20). The respective rates were 70% (95% CI, 51.3%-84.4%) and 85% (95% CI, 68.1%-94.9%) for all patients in the frontline setting (n = 33), as well as 14% (95% CI, 5.7%-26.3%) and 35% (95% CI, 22.4%-49.9%) for those with relapsed/refractory disease (n = 51).

The median overall survival (OS) was 16.6 months (95% CI, 7.2-not reached [NR]) among patients with first-line de novo disease and 16.6 months (95% CI, 11.4-NR) among all patients in the first-line setting. Among those with relapsed/refractory disease, the study treatment produced a median OS of 5.8 months (95% CI, 3.9-8.4).

In the open-label, multicenter phase 1/2 CADENZA trial, investigators assessed 2 groups of patients with CD123-positive BPDCN. One group included those with no prior exposure to systemic therapy, which was comprised of those with de novo BPDCN in the primary analysis population and those with BPDCN and prior or concomitant hematologic malignancies. The second patient group included those with relapsed/refractory disease following 1 to 3 prior lines of systemic treatment.

All patients enrolled on the trial received pivekimab sunirine at the recommended phase 2 dose of 0.045 mg/kg on day 1 of each 21-day cycle.

The trial’s primary end point was the CRc rate among patients with first-line de novo disease. A key secondary end point was the duration of CR plus CRc in the frontline de novo group. Other secondary end points included the CR plus CRc rate, time to CR plus CRc rate, ORR, OS, and frequency and severity of adverse effects (AEs).

The most common hematologic AEs in the frontline de novo, entire first-line, and relapsed/refractory groups, respectively, included anemia (15%, 27%, 14%), neutropenia (0%, 15%, 18%), and thrombocytopenia (20%, 36%, 31%). AEs associated with dose delays, dose reductions, and treatment discontinuations occurred in 25.0%, 4.8%, and 13.1% of patients, respectively.

AbbVie submits biologics license application (BLA) to U.S. FDA for pivekimab sunirine (PVEK) - an investigational antibody-drug conjugate (ADC) to treat rare cancer with limited treatment options. News release. AbbVie. September 30, 2025. Accessed September 30, 2025. https://tinyurl.com/ykzujenf

Pemmaraju N, Marconi G, Montesinos P, et al. Efficacy and safety of pivekimab sunirine (PVEK) in patients (pts) with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the CADENZA study. 

2025;43(suppl 16):6502. doi:10.1200/JCO.2025.43.16_suppl.6502

Data from the CADENZA trial support the application for pivekimab sunirine as a treatment for those with blastic plasmacytoid dendritic cell neoplasms.

FDA Receives BLA for Pivekimab Sunirine in Rare Hematologic Malignancy

A phase 1 trial is evaluating UB-VV111 with and without rapamycin as treatment for patients with CLL and LBCL who received at least 2 prior therapies.

The FDA has granted fast track designation to UB-VV111, an investigational, off-the-shelf CD-19-directed CAR T cell in vivo product, as a treatment for patients with relapsed/refractory large B-cell lymphoma (LBCL) and relapsed/refractory chronic lymphocytic leukemia (CLL) following 2 or more lines of therapy, according to a press release from the developer, Umoja Biopharma.

Previously, in July 2024, the developer announced that the FDA had cleared UB-VV111’s investigational new drug application.

 At the time of the release, the first patient was expected to be dosed by the end of 2024.

The dose-escalation and dose-confirmation phase 1 INVICTA-1 trial (NCT06528301) is currently evaluating the safety and antitumor activity of UB-VV111 with and without rapamycin in patients with LBCL and CLL. Details about the trial were shared in a poster at the 

It was found in nonclinical in vitro and in vivo pharmacology studies that UB-VV111 selectively binded, activated, and transduced T cells through the MDF protein to generate CAR T cells expressing an anti–CD19 CAR and the rapamycin-activated cytokine receptor system; that UB-VV111–generated CAR T cells mediated antigen-specific toxicity, cytokine secretion, and proliferation; and that CAR T-cell generation and activity were observed with and without rapamycin, but treatment with rapamycin selectively enriched and expanded CAR T cells.

Further, a 13-week Good Laboratory Practice toxicity study demonstrated that UB-VV111 was well-tolerated in CD34-humanized mice, with no UB-VV111–related mortalities or effects on body weight, clinical observations, human cytokine expression, hematology, chemistry, or gross pathology. The agent also achieved a favorable pharmacodynamic profile.

“This fast track designation marks a key milestone in the advancement of in vivo CAR T cell therapies,” stated Luke Walker, MD, chief medical officer of Umoja Biopharma, in the press release.

 “UB-VV111 continues to lead the in vivo CAR T cell field in the US, and today’s announcement further reinforces its potential to address unmet needs in the treatment of those living with relapsed/refractory B-cell malignancies. This achievement is a testament to the dedication of our clinical trial sites and to the patients who inspire our mission every day.”

The study was designed to assess the intranodal and intravenous routes of administration in patients with relapsed/refractory CLL or LBCL who are either CAR T cell-exposed or CAR T cell-naïve. In the dose-finding portion of the trial, the Bayesian optimal interval design was used to identify the maximum tolerated/administered doses of UB-VV111 with and without rapamycin. In the dose-expansion portion of the trial, patients were randomly assigned to dose levels demonstrating safety and activity to further optimize phase 2 dosing, with dosing potentially performed on a single route of administration or within a single patient group.

Enrolled patients were 18 years or older with relapsed or refractory LBCL or CLL after 2 prior lines of therapy who had measurable disease per Lugano 2014 criteria or International Workshop on CLL 2018 criteria, an ECOG performance status of 0 or 1, and adequate organ function. Additionally, those who previously received CD19-directed therapy must have had biopsy confirming CD19 expression following completion of prior CD19-directed therapy.

Exclusion criteria included current isolated central nervous system (CNS) involvement, history of or active HIV, ongoing CNS disease that precludes neurologic assessment, and current receipt of treatment in another interventional clinical trial. Patients also could not have received prior allogeneic bone marrow transplantation, gene therapy, or adoptive cell transfer, and could not have systemic autoimmune or immunodeficiency diseases.

The primary end points of the trial were determining the safety profile of UB-VV111 with and without rapamycin, and determining the maximum tolerated dose, maximum administered dose, and recommended phase 2 dose of UB-VV111. The secondary end point was preliminary efficacy, including overall response rate; exploratory end points were the pharmacokinetics and immunogenicity of UB-VV111 particles and CAR T cells, the translational correlation of biomarkers and observed safety and efficacy, and further preliminary efficacy data.

Umoja Biopharma announces that UB-VV111 receives FDA fast track designation for relapsed/refractory B-cell malignancies. News release. Umoja Biopharma. September 30, 2025. Accessed October 1, 2025. https://tinyurl.com/76zybhzn

Umoja Biopharma announces FDA clearance of IND application for UB-VV111, a CD19 directed in situ CAR T for hematologic malignancies. News release. Umoja Biopharma. July 31, 2024. Accessed October 1, 2025. https://tinyurl.com/4w26r8xw

Garcia J, Dehner C, Teoh J, Brandes A, Wallis W. A phase I, multicenter, open-label study of UB-VV111 in combination with rapamycin in relapsed/refractory CD19+ B-cell malignancies. 

. 2025;53(suppl 16):TPS2681. doi:10.1200/JCO.2025.43.16_suppl.TPS2681