Oncology

Suvemcitug plus chemotherapy prolongs survival in platinum-resistant recurrent ovarian cancer

Women with platinum-resistant recurrent ovarian cancer were randomized 2:1 to suvemcitug plus chemotherapy or placebo plus chemotherapy. Median PFS improved from 2.7 to 5.5 months with suvemcitug (HR 0.46, 95% CI 0.35-0.60; P < 0.001). Median OS increased from 14.0 to 15.3 months (HR 0.77, 95% CI 0.60-0.99; P = 0.03). Almost half of patients had prior antiangiogenic and PARP inhibitor exposure, supporting benefit in heavily pretreated populations. Grade ≥3 neutropenia and leukopenia were the most common toxicities; no suvemcitug-related grade 5 events occurred. 1

Tucatinib plus trastuzumab shows durable benefit in HER2+, RAS WT metastatic colorectal cancer

The phase 2 MOUNTAINEER trial evaluated tucatinib plus trastuzumab in chemotherapy-refractory, HER2+, RAS wild-type metastatic colorectal cancer. Among 84 treated patients, the confirmed objective response rate was 39.3%, with a median response duration of 15.2 months. Median PFS and OS were 8.1 and 23.9 months, respectively, supporting this chemotherapy-free regimen as a late-line option. Responses were observed across central HER2 testing methods and heterogeneous biomarker backgrounds, easing selection logistics. Few patients discontinued for toxicity, and no treatment-emergent deaths occurred, indicating favorable tolerability in this setting. 2

First-line osimertinib plus savolitinib enhances responses in EGFR-mutant, MET-aberrant NSCLC

The randomized phase 2 FLOWERS trial compared first-line osimertinib alone versus osimertinib plus savolitinib in EGFR-mutant NSCLC with de novo MET aberrations. Among 44 patients, ORR was 60.9% with osimertinib monotherapy versus 90.5% with the combination. Disease control exceeded 87% in both arms, favoring the combination numerically. Grade ≥3 treatment-related adverse events occurred in 8.7% with monotherapy versus 57.1% with combination therapy. These data support strong antitumor activity of dual EGFR–MET inhibition but highlight substantially increased toxicity. 3

Linavonkibart plus pembrolizumab shows activity in PD-1–resistant solid tumors

The DRAGON phase 1 trial evaluated linavonkibart, a selective anti-latent TGFβ1 antibody, alone and with pembrolizumab in advanced solid tumors. Dose escalation showed no dose-limiting toxicities and no grade 4-5 treatment-related events up to high intermittent doses. In part B, patients progressing on prior anti–PD-1 therapy received linavonkibart plus pembrolizumab across several tumor types. Confirmed ORR was 20.0% in clear cell RCC and 18.2% in melanoma, with 9.1% in head and neck and urothelial cancers. Safety was generally consistent with pembrolizumab monotherapy, with added dermatologic toxicity and no cytokine release or infusion interruptions. Biomarker analyses support on-target TGFβ1 modulation and suggest a selection strategy in clear cell RCC. 4