From the Watchtower · Page 2
Oncology intelligence, in the open.
Briefings 25–31 of 31, newest first.
Replimune's own filing shows the RP1 melanoma pivotal was a single-arm cohort — the randomized answer is dated 2030
Replimune's 8-K exhibit describes the melanoma registrational study as a 125-patient anti-PD-1-failed cohort, and the randomized Phase 3 IGNYTE-3 carries a primary completion date of 30 September 2030 — while FDA reviewers, per Endpoints News on 28 July 2026, told an advisory committee the pivotal design cannot show that RP1 works.
Sonesitatug vedotin won overall survival in CLARITY-Gastric01 and missed its PFS co-primary — and moved the CLDN18.2 bar to 25%
AstraZeneca's 27 July release names the trial and describes the caveat precisely — the PFS co-primary showed a trend but did not reach statistical significance. The competitive move is in the eligibility criterion: CLDN18.2 on at least 25% of tumour cells at any intensity, against the 75% moderate-to-strong that zolbetuximab's US label requires.
Daraxonrasib's NDA is accepted with a National Priority Voucher — which puts an FDA decision in weeks, not mid-2027
Revolution Medicines' 22 July release confirms the FDA accepted the daraxonrasib NDA in previously treated metastatic pancreatic cancer, and that the asset sits in the Commissioner's National Priority Voucher pilot — a programme the FDA targets at 1–2 months against 6+. No action date is published, but the voucher, not the acceptance, is the number a competitor should be planning against.
Ivonescimab's Western OS hazard ratio falls to 0.76 — Summit hasn't yet disclosed the number the FDA said it requires
Summit's July 22 HARMONi update shows the Western overall-survival HR converging on the ITT 0.76 as follow-up doubles — but with no median, CI or p-value disclosed, the FDA's statistical-significance requirement stays unresolved before the Nov 14 PDUFA.
AstraZeneca's NCT06764875 pits a rilvegostomig–Enhertu regimen against the pembrolizumab comparator in first-line HER2+ gastric cancer
A three-arm, 840-patient Phase 3 — recruiting now, primary completion estimated April 2029 — tests AstraZeneca's largely owned rilvegostomig-plus-Enhertu combination against trastuzumab + chemotherapy + pembrolizumab.
Elicio's KRAS vaccine missed its Phase 2 primary endpoint. It's staking a Phase 3 on the subgroup that worked.
ELI-002 7P failed disease-free survival in the AMPLIFY-7P intent-to-treat population — and Elicio is pressing into a larger, R0-enriched Phase 3 on a post-hoc result and a runway that ends in Q4 2026.
Spectrum Exits the Poziotinib Exon 20 Program: Four Trials Halted, Stated Reasons Explicitly Exclude Safety
Four terminated or suspended studies, zero Phase 3 enrollees, active FDA redesign talks: stated reasons across all Spectrum-sponsored poziotinib terminations explicitly exclude safety — the regulatory and strategic picture is the story.