Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jul 23
- 3 min read
Updated: Jul 24
22/07/2026
Ivonescimab plus chemotherapy delivers consistent overall survival gains across Western and Asian NSCLC patients, reinforcing FDA‑filed Phase III HARMONi data (Ref)
Summit Therapeutics released an updated overall survival analysis from its global Phase III HARMONi trial, showing that ivonescimab plus chemotherapy continues to outperform chemotherapy alone in EGFR-mutated NSCLC patients previously treated with a third-generation EGFR TKI. With longer follow-up, the survival benefit in western patients has now converged with the stronger results already seen in Asian patients, reinforcing the drug's global efficacy and safety profile.
Supporting data:
Consistent OS benefit: Hazard ratio improved across analyses — 0.79 (Apr 2025), 0.78 (Sept 2025), and 0.76 (June 2026) in the intention‑to‑treat population
Western subgroup alignment: Hazard ratio improved from 0.98 (Apr 2025) to 0.76 (June 2026), showing consistency with Asian patients
Median OS: 16.8 months with ivonescimab + chemo vs 14.0 months with placebo + chemo
Safety profile: Acceptable and manageable, no new signals
Upcoming milestones:
Detailed results of the study were provided in September 2025, and a Biologics License Application (BLA) was submitted to the United States Food and Drug Administration (FDA) for marketing authorization, which the FDA accepted for filing in January 2026; the goal Prescription Drug User Fee Act (PDUFA) date is November 14, 2026
US FDA grants Priority Review for talazoparib + enzalutamide in HRR‑mutated mCSPC, with a decision expected in Q4 2026 (Ref)
The US FDA has granted Priority Review for a supplemental New Drug Application (sNDA) of Pfizer’s talazoparib (TALZENNA; PARP inhibitor) + enzalutamide (XTANDI; androgen receptor pathway inhibitor) in HRR gene-mutated metastatic castration-sensitive prostate cancer (mCSPC), also known as metastatic hormone-sensitive prostate cancer (mHSPC)
A PDUFA action date is set for Q4 2026
The application is supported by data from the Phase 3 TALAPRO-3 trial
52% reduction in risk of radiographic progression or death vs placebo + XTANDI, consistent across BRCA and non-BRCA HRR alterations
The combination is already approved in the US for mCRPC (metastatic castration-resistant prostate cancer)
US FDA Accepts NDA for Daraxonrasib in Previously Treated Metastatic Pancreatic Cancer (Ref)
The US FDA accepted the New Drug Application (NDA) for Revolution Medicines' daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma (PDAC)
Daraxonrasib has Breakthrough Therapy and Orphan Drug Designations, and was selected for the FDA Commissioner’s National Priority Voucher pilot program to accelerate review
NDA supported by the Phase 3 RASolute 302 trial, which compared daraxonrasib to standard chemotherapy
Treatment with daraxonrasib led to significantly longer overall survival and progression-free survival than chemotherapy
Median OS: 13.2 months vs 6.7 months (HR: 0.40; P<0.001)
Median PFS: 7.2 months vs 3.6 months (HR: 0.49; P<0.001)
The European Medicines Agency (EMA) has begun a phased review of daraxonrasib, granting orphan medicine designation and high-priority status under its Cancer Medicines Pathfinder project
GSK's Jideytro (zidesamtinib) Gets US FDA Approval for ROS1-Positive Lung Cancer (Ref)
The US FDA approved zidesamtinib (Jideytro; ROS1 selective inhibitor) for adult patients with locally advanced or metastatic ROS1-positive NSCLC who have previously received a ROS1 kinase inhibitor
Approval granted ahead of schedule (original target date: 18 Sept 2026) and supported by Breakthrough Therapy and Orphan Drug Designations
The approval is based on results from the Phase I/II ARROS-1 clinical trial in patients with advanced or metastatic ROS1-positive NSCLC previously treated with a ROS1 inhibitor
Objective response rate (ORR): 44% (CI: 34–53%)
Duration of response (DOR): 82% at 6 months, 69% at 12 months
Responses observed even in patients with brain metastases and ROS1 resistance mutations
Common adverse events (≥15%): oedema, peripheral neuropathy, constipation, fatigue, dyspnoea
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