The OncFive: Top Oncology Articles for the Week of 6/14

Welcome to OncLive®’s OncFive!

Every week, we bring you a quick roundup of the 5 top stories from the world of oncology—ranging from pivotal regulatory decisions to key pipeline updates to expert insights on breakthroughs that are moving the needle in cancer care. This resource is designed to keep you informed on the latest updates in the space, in just a matter of minutes.

Here’s what you may have missed this week:

FDA Accepts sBLA for Subcutaneous Mosunetuzumab Plus Polatuzumab Vedotin in R/R LBCL

The FDA has accepted a supplemental biologics license application seeking approval of subcutaneous mosunetuzumab (Lunsumio Velo) paired with polatuzumab vedotin (Polivy) for use in adult patients with relapsed/refractory large B-cell lymphoma, including diffuse large B-cell lymphoma, after at least 1 previous line of systemic therapy. An FDA decision is expected by February 9, 2027. The application is supported by data from the phase 3 SUNMO trial (NCT05171647), in which mosunetuzumab plus polatuzumab vedotin (n = 138) achieved a median progression-free survival (PFS) per independent review committee (IRC) of 11.6 months (95% CI, 5.6-17.6) vs 3.8 months (95% CI, 2.9-4.1) with rituximab (Rituxan), gemcitabine, and oxaliplatin (R-GemOx; n = 70; HR, 0.41; 95% CI, 0.28-0.60); the 2-year PFS rates were 37.5% and 14.3%, respectively. The overall response rate (ORR) was 70.3% (95% CI, 61.9%-77.8%) with the combination vs 40.0% (95% CI, 28.5%–52.4%) with R-GemOx, and the median duration of response (DOR) was 18.8 months (95% CI, 11.5–not evaluable [NE]) vs 6.0 months (95% CI, 3.7–23.9), respectively.

Ozekibart BLA Is Under FDA Review in Conventional Chondrosarcoma

The FDA has accepted a biologics license application (BLA) for ozekibart (INBRX-109), a tetravalent death receptor 5 agonist antibody, for the treatment of adult patients with unresectable or metastatic conventional chondrosarcoma. A Prescription Drug User Fee Act goal date has been set for April 14, 2027. The BLA is supported by results from the registrational phase 2/3 ChonDRAgon trial (NCT04950075), in which ozekibart reduced the risk of disease progression or death by 52% vs placebo (stratified HR, 0.479; 95% CI 0.33-0.68; P < .0001), with median PFS increasing from 2.66 months with placebo to 5.52 months with ozekibart. The disease control rate (DCR) was 54% with ozekibart vs 27.5% with placebo, and the benefit was consistent across IDH wild-type and -mutant subgroups. Ozekibart previously received FDA fast track designation in January 2021 and orphan drug designation in November 2021, and is also being examined in combination with irinotecan-based regimens for Ewing sarcoma and colorectal cancer.

Fixed-Duration Pirtobrutinib Combo Drives PFS Benefit in R/R CLL

A prespecified interim analysis of the phase 3 BRUIN CLL-322 trial (NCT04965493), presented at the 2026 EHA Congress, showed that fixed-duration pirtobrutinib (Jaypirca) plus venetoclax (Venclexta) and rituximab (Rituxan; PVR) significantly improved PFS vs fixed-duration venetoclax and rituximab (VR) in patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (n = 639). At a median follow-up of 27.3 months, the median PFS per IRC assessment was NE (95% CI, 43.3-NE) with PVR (n = 321) vs 39.7 months (95% CI, 35.9-NE) with VR (n = 318; HR, 0.547; 95% CI, 0.400-0.748; P =.0001); the 24-month PFS rates were 86.9% vs 71.8%. The ORR was 88.5% (95% CI, 84.5%-91.8%) with PVR vs 83.3% (95% CI, 78.8%-87.3%) with VR (P = .0618), and undetectable measurable residual disease negativity at a 10⁻⁴ sensitivity was achieved in 86.3% of PVR-treated patients vs 60.7% with VR (P < .0001). Grade 3 or higher treatment-emergent adverse events occurred in 78.8% of patients with PVR (n = 316) vs 73.0% with VR (n = 311), with the most common being neutropenia or decreased neutrophil count; cardiovascular and tumor lysis syndrome rates remained low with no new safety signals.

Mocertatug Rezetecan Drives Rapid, Deep Responses in Platinum-Resistant Ovarian and Recurrent/Advanced Endometrial Cancer

An interim analysis of the phase 1 BEHOLD-1 study (NCT06431594), presented at the 2026 ESMO Gynaecological Cancers Congress, showed that mocertatug rezetecan (Mo-Rez), a novel B7-H4–directed antibody-drug conjugate, induced rapid and deep responses across B7-H4 expression levels in patients with platinum-resistant ovarian cancer and recurrent or advanced endometrial cancer. In the platinum-resistant ovarian cohort, the confirmed ORR at the 5.8-mg/kg dose level (n = 34) was 62% (95% CI, 44%-78%), with a median time to response of 1.4 months; confirmed ORRs at the 2.8-mg/kg (n = 35) and 4.8-mg/kg (n = 34) doses were 31% (95% CI, 17%-49%) and 53% (95% CI, 35%-70%), respectively. In the endometrial cancer cohort, the confirmed ORR at 4.8 mg/kg (n = 12) was 67% (95% CI, 35%-90%) vs 9% (95% CI, 0.2%-41%) at 2.8 mg/kg (n = 11). Based on these results, the 5.8-mg/kg and 4.8-mg/kg doses have been selected for examination in the global phase 3 BEHOLD-Ovarian01 (NCT07286266) and BEHOLD-Endometrial01 (NCT07286331) trials, respectively.

Experts Weigh in on Some of the Most Impactful Data in Melanoma From ASCO 2026

At the 2026 ASCO Annual Meeting, several melanoma datasets drew expert attention, led by primary data from the phase 3 OptimUM-02 trial (NCT05987332), in which darovasertib plus crizotinib (Xalkori) achieved a median PFS of 6.9 months (95% CI, 5.6-8.3) vs 3.1 months (95% CI, 1.8-4.2) with investigator's choice of therapy in HLA-A*02:01–negative metastatic uveal melanoma (HR, 0.42; 95% CI, 0.30-0.59; P < .0001), with experts calling it potentially practice-changing in a population with no FDA-approved options. A 5-year update of the phase 2 KEYNOTE-942 study (NCT03897881) demonstrated that intismeran autogene plus pembrolizumab (Keytruda) continued to reduce recurrence-free survival events (26.2% vs 46.0%; HR, 0.510; 95% CI, 0.294-0.887) and distant metastasis-free survival events (HR, 0.411; 95% CI, 0.200-0.843) vs pembrolizumab alone in resected high-risk melanoma. Early-phase cellular therapy data included OBX-115, which achieved a 67% objective response rate (ORR; 95% CI, 38%–88%) in checkpoint inhibitor–refractory advanced melanoma in the phase 1/2 Agni-01 study (NCT06060613), and anzutresgene autoleucel (anzu-cel), which produced a confirmed ORR of 56% in the all-melanoma population of the phase 1/2 IMA203-101 trial (NCT03686124). Sign up to read the full recap of the top presentations in melanoma from the meeting.