The OncFive: Top Oncology Articles for the Week of 8/2

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 Grants Accelerated Approval to RP1 Plus Nivolumab for Advanced Melanoma After Anti–PD-1 Therapy

The FDA has granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev; RP1), an oncolytic immunotherapy, in combination with nivolumab (Opdivo) for adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a PD-1–blocking antibody–based regimen. The decision followed a lengthy regulatory history—two prior complete response letters and a third biologics license application accepted in June 2026; this culminated in a 10-to-3 vote by the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee that the efficacy results from the phase 1/2 IGNYTE trial (NCT03767348) were evaluable and clinically meaningful. In the efficacy-evaluable population (n = 91), RP1 plus nivolumab elicited an objective response rate (ORR) of 24.2% (95% CI, 15.8%-34.3%), with a median duration of response (DOR) of 14.1 months (95% CI, 10.7-not reached). The most common non-laboratory adverse effects (AEs) reported in at least 10% of safety-evaluable patients (n = 140) included fatigue, pyrexia, infections, chills, and musculoskeletal pain.

NCCN Guidelines Add Gedatolisib-Based Regimens for Pretreated PIK3CA Wild-Type Advanced Breast Cancer

Gedatolisib (Revtorpyk) in combination with fulvestrant (Faslodex), with or without palbociclib (Ibrance), has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology for breast cancer as a preferred category 1 regimen for the second-line or subsequent-line treatment of patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation. This followed the FDA approval of the regimens on July 14, 2026. The inclusion was based on the PIK3CA wild-type cohort of the phase 3 VIKTORIA-1 trial (NCT05501886), in which the gedatolisib triplet (n = 131) led to a median progression-free survival (PFS) of 9.3 months (95% CI, 7.2-16.6) vs 2.0 months (95% CI, 1.8-2.3) with fulvestrant alone (n = 131; HR, 0.24; 95% CI, 0.17-0.35; P < .0001). The triplet elicited an ORR of 31.5% vs 1.0% with fulvestrant alone and a median DOR of 17.5 months (95% CI, 8.8-not evaluable [NE]); the gedatolisib doublet (n = 130) produced a median PFS of 7.4 months (95% CI, 5.5-9.9; HR, 0.33; 95% CI, 0.24-0.48; P < .0001). The prescribing information includes warnings for stomatitis, dermatologic AEs, hyperglycemia, and embryo-fetal toxicity, with stomatitis occurring in 72% of triplet-treated patients (grade 3/4, 22%).

FDA Grants Breakthrough Therapy Designation to Olomorasib in KRAS G12C+ Pancreatic Cancer

The FDA has granted breakthrough therapy designation to olomorasib, a next-generation KRAS G12C inhibitor, as monotherapy for patients with advanced pancreatic cancer harboring a KRAS G12C mutation who have received at least 1 previous systemic therapy, marking the agent’s second such designation. The decision was based on preliminary data from the phase 1/2 LOXO-RAS-20001 trial (NCT04956640) examining olomorasib in patients with KRAS G12C–mutant advanced solid tumors, including pancreatic cancer. In the previously reported non–small cell lung cancer (NSCLC) cohort, olomorasib plus pembrolizumab (Keytruda; n = 46) yielded an ORR of 74% (95% CI, 59.8%-85.7%) and a disease control rate (DCR) of 91% (95% CI, 79.2%-97.6%), rising to a 90% ORR (95% CI, 68.3%-98.8%) in those with PD-L1 expression of at least 50% (n = 20). The first breakthrough therapy designation, granted in September 2025, was for olomorasib plus pembrolizumab in first-line KRAS G12C–mutant NSCLC.

FDA Grants Fast Track Designation to BI-1808 Plus Pembrolizumab in Ovarian Cancer

The FDA has granted fast track designation to BI-1808, a first-in-class anti–tumor necrosis factor receptor 2 monoclonal antibody, in combination with pembrolizumab for patients with ovarian cancer. The decision was supported by interim results from the combination cohort of an ongoing phase 2a study (NCT04752826) presented at the 2026 ASCO Annual Meeting. In heavily pretreated patients with advanced platinum-resistant ovarian cancer, BI-1808 plus pembrolizumab induced a confirmed ORR of 24% and a DCR of 56% with a median PFS of 10.3 months. Responses were observed across both high-grade serous and clear cell subtypes. Across 74 patients with solid tumors who received the combination, it was well tolerated, with manageable immune-related AEs, a low rate of grade 3 or higher AEs, and a treatment-related discontinuation rate of less than 5%. Cohort expansion focusing on the high-grade serous and clear cell subtypes is underway, with an additional data readout expected in the second half of 2026.

FDA Approves Rituximab Biosimilar for Hematologic Malignancies

The FDA has approved a rituximab biosimilar (Reditux), developed by Dr. Reddy’s Laboratories and referencing Rituxan (rituximab), for the treatment of select patients with hematologic malignancies. The decision was supported by a body of analytical, nonclinical, and clinical evidence showcasing that the biosimilar is highly similar to the reference product, with no clinically meaningful differences in safety, purity, and potency; this followed a pre-license inspection at the company’s biologics manufacturing facility in Hyderabad, India. The reference product is approved across several oncology indications, including relapsed or refractory low-grade or follicular CD20-positive B-cell non-Hodgkin lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and previously treated CD20-positive chronic lymphocytic leukemia. The biosimilar has already been commercialized in India, the European Union, the United Kingdom, and more than 25 emerging markets, and has received marketing approval in Switzerland and Canada.