The OncFive: Top Oncology Articles for the Week of 10/11

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 Approves Nogapendekin Alfa Inbakicept Plus BCG for High-Grade, Papillary-Only BCG-Unresponsive NMIBC

The FDA approved nogapendekin alfa inbakicept-pmln (Anktiva) plus BCG for adults with BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) with high-grade papillary-only tumors, expanding the regimen’s prior indication in BCG-unresponsive NMIBC with carcinoma in situ (CIS) with or without papillary tumors. The approval was based on cohort A of the single-arm phase 2/3 QUILT-3.032 trial (NCT03022825), in which patients treated with the combination (n = 77) achieved a complete response (CR) rate of 62% (95% CI, 51%-73%). Among patients with a CR, 58% had a duration of response (DOR) of at least 12 months, and 40% had a DOR of at least 24 months. The most common adverse effects (AEs) occurring in at least 15% of patients included increased creatinine, dysuria, hematuria, urinary frequency, micturition urgency, urinary tract infection, increased potassium, musculoskeletal pain, chills, and pyrexia. Citing overlapping clinical and nonclinical features between high-grade papillary NMIBC and NMIBC with CIS, the FDA decided that the prior demonstration of efficacy in the CIS cohort could be extrapolated to patients with BCG-unresponsive, high-grade, papillary-only NMIBC, following a May 2025 refusal-to-file letter and a resubmission that added long-term data from cohort B.

CHMP Recommends Approval of Daraxonrasib for Previously Treated Metastatic Pancreatic Cancer

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for daraxonrasib (Rasonque) monotherapy in adults with metastatic pancreatic adenocarcinoma who have received at least 1 prior systemic therapy. In the phase 3 RASolute 302 trial (NCT06625320), daraxonrasib (n = 248) produced a median overall survival (OS) of 13.2 months (95% CI, 10.0-not estimable [NE]) vs 6.7 months (95% CI, 5.8-8.0) with investigator’s choice of chemotherapy (n = 252) in the overall population (HR, 0.40; 95% CI, 0.30-0.53; P = 4.6 × 10⁻¹¹). Median progression-free survival (PFS) by blinded independent central review (BICR) was 7.2 months (95% CI, 5.7-7.5) vs 3.6 months (95% CI, 2.9-4.2), respectively (HR, 0.49; 95% CI, 0.38-0.64; P = 5.2 × 10⁻⁸), and the confirmed objective response rate (ORR) by BICR in the overall population was 31.6% vs 11.2% (P < .0001). Grade 3 or higher treatment-related adverse effects (TRAEs) occurred in 43.6% of patients in the daraxonrasib arm vs 57.5% of those in the chemotherapy arm, and TRAEs led to discontinuation in 1.2% vs 11.2%. The most common TRAEs with daraxonrasib were rash (85%), diarrhea (58%), and stomatitis (53%). The European Commission will now issue a final decision, following the August 2026 FDA approval of daraxonrasib, and the agent is being evaluated in the frontline setting in the phase 3 RASolute 303 trial (NCT07491445).

FDA Accepts BLA Resubmission for Tabelecleucel in EBV+ Post-Transplant Lymphoproliferative Disease

The FDA accepted the resubmitted biologics license application (BLA) for tabelecleucel (Ebvallo), an allogeneic, off-the-shelf, Epstein-Barr virus (EBV)–specific T-cell immunotherapy, as monotherapy for patients aged 2 years and older with EBV-positive post-transplant lymphoproliferative disease (PTLD) who have received at least 1 prior therapy, setting a Prescription Drug User Fee Act target action date of March 31, 2027. The third BLA submission includes additional patients and longer follow-up from the pivotal, single-arm phase 3 ALLELE trial (NCT03394365), following a January 2026 complete response letter (CRL) in which the FDA deemed the single-arm data insufficient and a Type A meeting at which the agency agreed that a single-arm study with an appropriate prespecified historical control could be adequate. In an updated ALLELE analysis presented at the 2024 ASH Annual Meeting and Exposition, tabelecleucel (n = 75) produced an ORR of 50.7% (95% CI, 38.9%-62.4%), including a CR rate of 28.0%, with a median DOR of 23.0 months (95% CI, 12.1-NE) and a median OS of 18.4 months (95% CI, 6.9-NE). Serious treatment-emergent adverse effects (TEAEs) occurred in 62.7% of patients, with 8.0% experiencing serious TEAEs considered related to tabelecleucel, and no cases of tumor flare, cytokine release syndrome, or immune effector cell–associated neurotoxicity syndrome were reported. Responses were similar among patients who had undergone allogeneic hematopoietic cell transplant (ORR, 50.0%; n = 26) and solid organ transplant (ORR, 51.0%; n = 49), and tabelecleucel is already authorized in the European Union, the United Kingdom, and Switzerland.

RYZ101 Meets Primary PFS End Point in Phase 3 ACTION-1 Trial for Post–Lutetium-177 GEP-NETs

RYZ101 (225Ac-DOTATATE) produced a statistically significant and clinically meaningful PFS improvement by BICR vs investigator’s choice of standard-of-care therapy in patients with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs) whose disease progressed after lutetium-177 (Lu-177)–based therapy, meeting the primary end point of the phase 3 ACTION-1 trial (NCT05477576). ACTION-1 enrolled 343 patients with inoperable, advanced, well-differentiated, grade 1 or 2 SSTR-positive GEP-NETs (Ki-67 ≤20%) who had progressed after 2 to 4 cycles of Lu-177–labeled somatostatin analogue therapy following at least 6 months of disease control. The control arm received high-dose or high-frequency long-acting octreotide or lanreotide, everolimus (Afinitor), or sunitinib (Sutent). Detailed results will be presented at a future medical meeting, and the safety profile was consistent with prior experience. RayzeBio plans to engage the FDA on a regulatory submission; RYZ101 received FDA orphan drug designation in GEP-NETs in August 2026, and patients will continue to be followed for OS.

FDA Receives NDA Resubmission for Rivoceranib Plus Camrelizumab in Frontline Unresectable or Metastatic HCC

A new drug application (NDA) seeking approval of camrelizumab plus rivoceranib for the first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) was resubmitted to the FDA on October 9, 2026, in response to a third CRL issued in July 2026. In the final analysis of the phase 3 CARES-310 trial (NCT03764293; n = 543) the combination produced a median OS of 23.8 months (95% CI, 20.6-27.2) vs 15.2 months (95% CI, 13.2-18.5) with sorafenib (Nexavar) at a median follow-up of 22.1 months (HR, 0.64; 95% CI, 0.52-0.79; P < .0001). Median PFS was 5.6 months (95% CI, 5.5-7.4) vs 3.7 months (95% CI, 3.1-3.7), respectively (HR, 0.54; 95% CI, 0.44-0.67; P < .0001). The most common grade 3 or higher TRAEs in the combination arm included hypertension (38.2%), increased aspartate aminotransferase (17.3%), increased alanine aminotransferase (14.0%), and palmar-plantar erythrodysesthesia (12.1%), and TRAEs led to discontinuation of both agents in 4.4% of patients. This is the fourth submission of the NDA, and the July 2026 CRL cited current good manufacturing practice deficiencies at a manufacturing site.