Oncology ·
FDA approves talazoparib with enzalutamide for HRR-mutated prostate cancer; divarasib beats KRAS G12C inhibitors; petosemtamab improves survival
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The Food and Drug Administration (FDA) on Oct. 26 approved talazoparib with enzalutamide for metastatic androgen pathway modulation-naive or -sensitive prostate cancer with homologous recombination repair gene mutations.
At the European Society for Medical Oncology (ESMO) Congress, divarasib extended progression-free survival over sotorasib or adagrasib, and Genmab said petosemtamab plus pembrolizumab improved overall survival in head and neck cancer. The American Society for Radiation Oncology (ASTRO) backed moderate hypofractionation in prostate cancer.
THE DETAILS
- FDA Oct 26, 2026The Food and Drug Administration (FDA) on Oct. 26 approved talazoparib (Talzenna, Pfizer) with enzalutamide for adults with metastatic androgen pathway modulation-naive or -sensitive prostate cancer with homologous recombination repair (HRR) gene mutations detected by an FDA-authorized test. In the TALAPRO-3 trial of 599 patients, investigator-assessed median radiographic progression-free survival, the primary end point, was not reached with talazoparib plus enzalutamide versus 45.8 months with placebo plus enzalutamide (hazard ratio 0.48, 95% CI 0.36 to 0.65; P < .0001). Interim overall survival was immature and not significant (hazard ratio 0.77; 95% CI 0.56 to 1.04; P = .09), Pfizer said.Source: FDA
- Research Oct 25, 2026In the phase 3 Krascendo 1 trial of 338 patients with pretreated KRAS G12C-mutated lung cancer, Roche's divarasib 400 mg daily lengthened median progression-free survival by blinded central review, the primary end point, to 9.8 from 5.7 months with sotorasib or adagrasib (hazard ratio 0.58, 95% CI 0.44 to 0.76). At first interim analysis, median overall survival was 17.7 versus 12 months (hazard ratio 0.56, 95% CI 0.41 to 0.78). Grade 3 or 4 treatment-related adverse events occurred in 24.6% versus 34.5%. The New England Journal of Medicine published the results, presented at the European Society for Medical Oncology Congress.
- Research Oct 28, 2026Genmab said the phase 3 LiGeR-HN1 trial of petosemtamab plus pembrolizumab versus pembrolizumab alone met both co-primary end points, overall survival and objective response rate, in first-line PD-L1-positive recurrent or metastatic head and neck squamous cell carcinoma. At the first interim analysis, the hazard ratio for overall survival was 0.50 (95% CI 0.37 to 0.67; P < .0001) and the odds ratio for objective response was 3.17 (95% CI 2.06 to 4.89), regardless of HPV status, according to the company. The company-reported topline results are not peer reviewed; Genmab said it will present full results at a future meeting.
- Research Oct 25, 2026In the phase 3 SAFFRON trial, 338 patients with EGFR-mutant non-small cell lung cancer with MET overexpression or amplification after osimertinib were assigned osimertinib-savolitinib or platinum-pemetrexed. Median progression-free survival, the primary end point, was 7.6 versus 5.4 months (hazard ratio 0.55, 95% CI 0.42 to 0.72). Median overall survival, a secondary end point, was 17.8 versus 12.9 months (hazard ratio 0.68, 95% CI 0.50 to 0.91). Grade 3 or worse adverse events occurred in 40% versus 52%. The AstraZeneca-funded study was presented at the European Society for Medical Oncology Congress and published in the New England Journal of Medicine.
- Research Oct 27, 2026In company-reported topline results, Pfizer said elranatamab monotherapy met the primary end point of progression-free survival by blinded independent central review versus investigator's choice of EloPd, PVd or Kd in relapsed or refractory multiple myeloma after one to four prior lines including an anti-CD38 antibody and lenalidomide. At the prespecified interim analysis, the estimated 18-month progression-free survival rate with elranatamab was 68%; overall survival, a key secondary end point, was immature. Grade 3 or higher infections occurred in 27.5% of patients with elranatamab versus 18.1% with investigator's choice. Pfizer plans to submit the data to regulators, OncLive said.Sources: OncLive, CancerNetwork
- Guidelines Oct 27, 2026An American Society for Radiation Oncology (ASTRO) guideline published online Oct. 27 in Practical Radiation Oncology replaces its 2018 recommendations and favors moderate hypofractionation, 60 to 62 Gy in 20 fractions or 70 Gy in 28 fractions, over conventional fractionation for all risk groups. Ultrahypofractionation is an option for intermediate-risk disease and low-risk disease when patients forgo active surveillance, and is conditional in high-risk disease; fewer than five fractions is not recommended outside a trial. Stereotactic body radiation therapy is now a standard option for many patients, said task force chair Dr. Scott C. Morgan.Sources: Practical Radiation Oncology, OncLive
- Research Oct 25, 2026In the phase 3 HARMONi-GI1 trial of 682 patients in China with previously untreated advanced biliary tract cancer, ivonescimab plus gemcitabine and cisplatin improved median overall survival, the primary end point, to 14.9 months from 12.1 months with durvalumab plus chemotherapy at an interim analysis (hazard ratio 0.75, 95% CI 0.61 to 0.92; one-sided P = .0031), according to Summit Therapeutics. The Akeso-sponsored data were presented in a Presidential Symposium at the European Society for Medical Oncology Congress. Ivonescimab is not approved in the U.S., and Summit said a registration-enabling U.S. study with ECOG-ACRIN is planned.Sources: Summit Therapeutics, Targeted Oncology
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