The OncFive: Top Oncology Articles for the Week of 1/11

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 Issues CRL for Tabelecleucel in EBV+ Post-Transplant Lymphoproliferative Disease

The FDA issued a complete response letter (CRL) to the biologics license application (BLA) seeking approval of tabelecleucel (Ebvallo) for Epstein-Barr virus (EBV)–positive post-transplant lymphoproliferative disease following progression on standard therapy. The BLA was supported by findings from the phase 3 ALLELE trial (NCT03394365), which examined tabelecleucel in patients with relapsed or refractory disease after solid organ transplant or hematopoietic stem cell transplant. Although the regulatory agency acknowledged that previously cited third-party manufacturing issues were resolved and raised no safety concerns, the agency stated that the single-arm ALLELE study was no longer sufficient to support accelerated approval of the drug and requested a new study. Updated ALLELE findings shared at the 2024 ASH Annual Meeting showed that tabelecleucel (n = 75) elicited an overall response rate (ORR) of 50.7%, with a median duration of response (DOR) of 23 months and a median overall survival of 18.4 months. Tabelecleucel continues to be examined in a phase 2 multicohort label-expansion study (NCT04554914) across EBV-associated diseases.

FDA Receives BLA for Ivonescimab Plus Chemo in Second-Line or Later EGFR-Mutant NSCLC

A BLA was submitted to the FDA seeking approval of ivonescimab for use in combination with carboplatin and pemetrexed in patients with EGFR-mutated locally advanced or metastatic nonsquamous non–small cell lung cancer in the second line or later. The application is supported by findings from the phase 3 HARMONi trial (NCT06396065), which met its primary end point of progression-free survival (PFS). At a median follow-up of 22.3 months, median PFS was 6.8 months with ivonescimab plus chemotherapy (n = 172) vs 4.4 months with placebo plus chemotherapy (n = 173; HR, 0.52; 95% CI, 0.41-0.66; P < .0001). A positive trend toward improved overall survival (OS) was also observed; in the respective arms, the median OS was 16.8 months and 14.0 months, respectively (HR, 0.79; 95% CI, 0.62-1.01; P = .0570). Summit Therapeutics anticipates an FDA decision by the fourth quarter of 2026 if the application is accepted.

Pimicotinib NDA in Tenosynovial Giant Cell Tumor Is Under FDA Review

The FDA accepted a new drug application seeking approval of pimicotinib (ABSK021) for the systemic treatment of patients with tenosynovial giant cell tumor. The application is supported by data from the phase 3 MANEUVER trial (NCT05804045), which showed that at a median follow-up of 14.3 months, the selective CSF-1R inhibitor (n = 63) induced a blinded independent review committee–assessed ORR of 76.2% (95% CI, 63.8%-86.0%) per RECIST 1.1 criteria. Best responses included complete responses in 6.3% and partial responses in 69.8% of patients, with a 12-month DOR rate of 92% (95% CI, 70%-98%). The most frequently reported treatment-emergent adverse effects linked with pimicotinib included pruritus, facial edema, periorbital edema, fatigue, nausea, and headache.

FDA Accepts sBLA for Ropeginterferon-Alfa-2b for Essential Thrombocythemia

The FDA accepted a supplemental biologics license application (sBLA) seeking approval of ropeginterferon alfa-2b-njft (Besremi) for use in adult patients with essential thrombocythemia and set a Prescription Drug User Fee Act target action date of August 30, 2026. The submission was supported by data from the phase 3 SURPASS-ET trial (NCT04285086) and the phase 2b EXCEED-ET trial (NCT05482971). In SURPASS-ET, ropeginterferon alfa-2b (n = 91) achieved a significantly higher durable modified European LeukemiaNet response rate at 9 and 12 months vs anagrelide (42.9% vs 6.0%; P = .0001). Treatment was also linked with reductions in JAK2 V617F allele burden and lower rates of major thromboembolic events at 12 months vs anagrelide. Ropeginterferon alfa-2b is currently approved for polycythemia vera, and the sBLA seeks to expand its label to include essential thrombocythemia.

Teclistamab Monotherapy Improves OS and PFS Over SOC in Relapsed/Refractory Multiple Myeloma

Teclistamab-cqyv (Tecvayli) monotherapy significantly improved PFS and OS vs standard-of-care therapy in patients with relapsed or refractory multiple myeloma, according to topline data from the phase 3 MajesTEC-9 trial (NCT05572515). Teclistamab reduced the risk of disease progression or death by 71% (HR, 0.29; 95% CI, 0.23-0.38) and the risk of death by 40% (HR, 0.60; 95% CI, 0.43-0.83), with benefit observed as early as the second-line setting. The majority of enrolled patients were refractory to anti-CD38 therapy and lenalidomide (Revlimid). The toxicity profile of single-agent teclistamab was consistent with what has been observed in previous studies; no new safety signals were observed. These data build on what was reported from the phase 3 MajesTEC-3 study (NCT05083169), which evaluated teclistamab in combination with daratumumab and hyaluronidase-fihj (Darzalex Faspro).