Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- 10 minutes ago
- 2 min read
24/08/2026
EC Expands Trodelvy + Keytruda Approval to First-Line Metastatic TNBC Across PD-L1 Status (Ref)
European Commission’s expanded approval of Gilead’s Trodelvy (sacituzumab govitecan-hziy; Trop-2–directed ADC) in combination with Keytruda (pembrolizumab; anti-PD-1) for first-line treatment of PD-L1–positive metastatic triple-negative breast cancer (TNBC)
Regulatory milestone: Trodelvy becomes the first ADC approved in first-line metastatic TNBC across PD-L1 status in the EU, Norway, Iceland, and Liechtenstein
Clinical evidence: Approval is based on the Phase 3 ASCENT-04/KEYNOTE-D19 trial, which showed a 35% reduction in risk of progression or death compared to chemotherapy + Keytruda, with significant progression-free survival benefit
US FDA accepts Jemperli for priority review in dMMR/MSI-H rectal cancer (Ref)
The US FDA has accepted GSK’s supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab; anti-PD-1), granting priority review for use in previously untreated stage II and III dMMR/MSI-H locally advanced rectal cancer. The FDA’s decision date (PDUFA) is set for February 2027
Clinical evidence: The Phase II AZUR-1 trial (154 patients) demonstrated sustained clinical complete response at 12 months, with many patients showing no detectable cancer for at least a year. Safety was consistent with prior data
Jemperli has Fast Track and Breakthrough Therapy Designations in this setting. The application is also part of Project Orbis, enabling coordinated international reviews
US FDA Fast Track designation granted for ERAS-0015 in metastatic pancreatic cancer; Phase 3 trial planned (Ref)
Erasca announced that the US FDA has granted Fast Track Designation to ERAS-0015, its oral pan-RAS molecular glue, for patients with metastatic pancreatic adenocarcinoma
In the ongoing AURORAS-1 Phase 1 trial, ERAS-0015 demonstrated a 57% overall response rate at 8 weeks in KRAS G12X pancreatic cancer patients, with favorable tolerability. Responding patients remained on treatment at cutoff
Erasca plans to initiate a Phase 3 pancreatic cancer trial and two potentially registration-enabling lung cancer studies. Additional monotherapy and combination data (including panitumumab) are expected in 1H 2027
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