The OncFive: Top Oncology Articles for the Week of 9/14/2026

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 Clears sNDA for Taletrectinib With Updated DOR Data in ROS1+ NSCLC

The FDA has cleared a supplemental new drug application (sNDA) for taletrectinib (Ibtrozi) to update the label with new duration of response (DOR) data in TKI-naive patients with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC), a decision that came 4 months ahead of the Prescription Drug User Fee Act date. The decision incorporates an additional 14 months of follow-up from the phase 2 TRUST-I (NCT04395677) and TRUST-II (NCT04919811) trials, with the label now reporting a median DOR of 49.7 months (95% CI, 41.3-not reached [NR]) among TKI-naive patients in TRUST-I (n = 103) at a median follow-up of 51 months. In TKI-naive patients, the overall response rate (ORR) was 90% (95% CI, 83%-95%) in TRUST-I and 85% (95% CI, 73%-93%) in TRUST-II (n = 54), 72% and 59% of TRUST-I responders remained in response at 12 and 24 months, respectively. The median DOR in TRUST-II was NR (95% CI, 20.6-NR). Adverse effects (AEs) were serious in 31% of the pooled TRUST-I and TRUST-II population (n = 337) and fatal in 5%, with dose reductions, interruptions, and discontinuations due to AEs in 29%, 41%, and 7% of patients, respectively. The most common any-grade AEs were diarrhea (64%), nausea (47%), and vomiting (43%), and the most frequent laboratory abnormalities were increased aspartate aminotransferase (87%) and alanine aminotransferase (85%). The update follows the June 2025 approval of taletrectinib, when ORRs in ROS1 TKI-pretreated patients were 52% (95% CI, 39%-64%) in TRUST-I (n = 66) and 62% (95% CI, 46%-75%) in TRUST-II (n = 47); according to sponsor Nuvation Bio, the 49.7-month median DOR is the longest reported for an FDA-approved ROS1 TKI.

FDA Approves Imlunestrant Plus Abemaciclib for ER+, HER2–, ESR1-Mutated Metastatic Breast Cancer

The FDA approved imlunestrant (Inluriyo) plus abemaciclib (Verzenio) for adults with estrogen receptor (ER)–positive, HER2–negative, ESR1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, whose disease progressed after 1 or more lines of endocrine therapy. The approval was supported by an exploratory subgroup analysis of patients with ESR1-mutated disease (n = 159) from the phase 3 EMBER-3 trial (NCT04975308), in which imlunestrant plus abemaciclib (n = 67) yielded a median progression-free survival (PFS) of 11.1 months (95% CI, 7.4-13.7) vs 5.5 months (95% CI, 3.8-7.2) with imlunestrant monotherapy (n = 92; estimated HR, 0.53; 95% CI, 0.35-0.80). The ORR was 35% (95% CI, 22%-48%) with the combination vs 15% (95% CI, 7%-23%) with monotherapy, with complete response (CR) rates of 1.9% vs 1.4% and partial response rates of 33% vs 14%. While overall survival (OS) data were immature at the interim analysis, with a death rate of 35% in the ESR1-mutated population. Among safety-evaluable patients who received the combination (n = 208), the most common grade 3/4 AEs were diarrhea (9%), infections (7%), and fatigue (5%), and worsening laboratory abnormalities included decreased neutrophil counts (21%) and decreased hemoglobin levels (9%). The FDA simultaneously approved the Guardant360 CDx assay as a companion diagnostic for identifying patients with ESR1 mutations; of note, imlunestrant monotherapy did not show a PFS benefit vs investigator's choice of endocrine therapy in the overall EMBER-3 population (n = 874) or in those without detected ESR1 mutations.

FDA Approves Aminolevulinic Acid Hydrochloride Plus PDT for Basal Cell Carcinoma

The FDA approved aminolevulinic acid hydrochloride (Ameluz) topical gel in combination with photodynamic therapy (PDT) using the BF-RhodoLED lamp series for adults with superficial basal cell carcinoma, which sponsor Biofrontera describes as the first and only PDT approved in the US for a skin cancer. The approval was based on a multicenter, randomized, double-blind, vehicle-controlled phase 3 trial (NCT03573401) in which 66% of patients treated with aminolevulinic acid hydrochloride plus PDT (n = 145) achieved both clinical and histologic CR of the main target lesion 12 weeks after the start of the last PDT cycle vs 5% with vehicle plus PDT (n = 45). Histologic clearance of the main target lesion was 76% with aminolevulinic acid hydrochloride plus PDT vs 19% with vehicle plus PDT, and complete clinical clearance of all target lesions was 83% vs 21%, respectively. All patients in the aminolevulinic acid hydrochloride arm had at least 1 application-site AE, with the most common any-grade AEs being pain (aminolevulinic acid hydrochloride plus PDT, 95%; vehicle plus PDT, 29%), erythema (69%; 36%), and pruritus (50%; 26%). Each PDT cycle comprised 2 sessions 7 to 14 days apart, with the lesion covered in gel or placebo for 3 hours before illumination, and M. Shane Chapman, MD, MBA, of the Dartmouth Hitchcock Medical Center and the Dartmouth Geisel School of Medicinenoted that the approval gives dermatologists a non-surgical, in-office option, particularly for patients with multiple lesions, lesions in cosmetically sensitive locations, or for whom surgery is not preferred.

FDA Withdraws Indication for Adagrasib Plus Cetuximab in Previously Treated, KRAS G12C–Mutated mCRC

On September 1, 2026, the FDA removed the accelerated approval indication for adagrasib (Krazati) plus cetuximab (Erbitux) in patients with KRAS G12C–mutated locally advanced or metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The action followed the final readout of the phase 3 KRYSTAL-10 trial (NCT04793958), presented at the 2026 European Society for Medical Oncology Gastrointestinal Cancers Annual Congress, which did not meet either dual primary end point of OS or PFS for adagrasib plus cetuximab vs chemotherapy. At a minimum follow-up of 26.4 months, median OS was 21.6 months (95% CI, 18.4-25.5) with adagrasib plus cetuximab (n = 231) vs 21.7 months (95% CI, 18.0-24.8) with chemotherapy (n = 230; HR, 0.83; 95% CI, 0.67-1.03; P = .0938). At a minimum follow-up of 16.4 months, median PFS was 7.5 months (95% CI, 6.3-9.2) vs 8.1 months (95% CI, 7.3-9.2; HR, 0.89; 95% CI, 0.71-1.13; P = .3241). The ORR with the combination was 47% (95% CI, 40%-53%) vs 16% (95% CI, 11%-21%) with chemotherapy and median DOR was 9.2 months (95% CI, 7.4-11.1) vs 9.4 months (95% CI, 5.6-11.8). Grade 3 to 5 treatment-related treatment-emergent AEs (TEAEs) occurred in 46% of safety-evaluable patients in the combination arm (n =230) vs 55% in the chemotherapy arm (n = 206), treatment-related TEAEs led to discontinuation in 3% vs 2%, and one treatment-related death (sepsis) occurred in the chemotherapy arm. Accelerated approval was granted June 21, 2024, based on the phase 1/2 KRYSTAL-1 trial (NCT03785249), in which adagrasib plus cetuximab produced a confirmed ORR of 34% (95% CI, 25%-45%), all partial responses, and a median DOR of 5.8 months (95% CI, 4.2-7.6).

FDA Approves Lutetium Lu 177 Dotatate Injection for SSTR+ GEP-NETs

The FDA approved lutetium Lu 177 dotatate injection (Bexlutry) for adults with somatostatin receptor (SSTR)–positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut tumors. This radioligand therapy delivers targeted radiation by binding to SSTRs commonly expressed on these tumors, and its approval was supported by data showing a biological and chemical profile similar to the previously approved lutetium Lu 177 dotatate (Lutathera). Efficacy data came from the single-site ERASMUS study (n = 1214), a protocol written after initiation that allowed retrospective data collection, in which 360 patients had GEP-NETs with long-term follow-up and investigator-assessed ORR served as the primary end point. The investigator-assessed ORR was 17% (95% CI, 13%-21%), including 3 CRs, in an analysis requiring responders to undergo prospective response assessments per RECIST critera, and the median DOR among responders (n = 60) was 35 months (95% CI, 17-38). Patients received 7.4 GBq (200 mCi) every 6 to 13 weeks for a maximum of 4 doses with an amino acid solution.