Jason M. Broderick

FDA cleared pegfilgrastim-pccg for the same indications as pegfilgrastim, including chemotherapy-associated febrile neutropenia prophylaxis and survival benefit after myelosuppressive radiation exposure causing Hematopoietic Subsyndrome of ARS.

KEYNOTE-C93 demonstrated BICR-assessed PFS superiority for pembrolizumab monotherapy over platinum doublet chemotherapy in frontline dMMR advanced/recurrent endometrial cancer. Overall survival trended positively with pembrolizumab, but immature data preclude definitive conclusions regarding survival advantage vs chemotherapy.

INVINCIBLE-4 randomizes operable TNBC to INT230-6 pre-treatment followed by KEYNOTE-522–like neoadjuvant pembrolizumab/chemotherapy versus standard therapy alone, with pCR in breast and nodes as primary endpoint. Accrual restarted after protocol amendments addressing cutaneous irritation by reducing drug-to-tumor volume ratio and switching to a single intratumoral injection, with enrollment planned across Switzerland and France.

Systemic responses were observed across both Alpha DaRT-treated and untreated lesions per RECIST v1.1, supporting a potential abscopal/immune-amplifying interaction with PD-1 blockade. Median OS 18.2 months and PFS 5.4 months compared favorably with KEYNOTE-048 pembrolizumab monotherapy historical outcomes, acknowledging substantial cross-trial design and population differences.

FDA accepted an NDA for daraxonrasib in previously treated metastatic PDAC, supported by RASolute 302 and prior breakthrough therapy and orphan drug designations. Phase 3 RASolute 302 showed OS nearly doubled versus chemotherapy in RAS G12 tumors (13.2 vs 6.6 months; HR 0.40) and was consistent in the overall population.

CLARITY-Gastric01 met dual OS primary end points, showing statistically significant, clinically meaningful benefit for Sone‑Ve over chemotherapy in third-line+ and overall second-line+ cohorts. Blinded independent central review demonstrated only a PFS improvement trend in second-line+ disease, failing to reach statistical significance despite OS gains.

Priority review positions subcutaneous amivantamab as a potential first-in-class EGFR/MET-targeted option after platinum and PD-1/PD-L1 failure in HPV-unrelated R/M HNSCC. Blinded central review showed 42% ORR with 15% CR; 56% of responses persisted ≥6 months and 63% were ongoing at analysis.

"Although I am disappointed that the PFS improvement was not statistically significant, I look forward to continuing to follow these results," Robert Coleman, MD.

KEYNOTE-689 demonstrated superior EFS with neoadjuvant plus adjuvant pembrolizumab (median 51.8 vs 30.4 months; HR 0.73), establishing clinical benefit for perioperative immunotherapy in resectable HNSCC. Partitioned survival modeling estimated CPS >10 gains of ~1.35 QALYs at ~$181,900 incremental cost, producing an ICER of ~$134,700, consistent with US $150,000 willingness-to-pay benchmarks.

ERAS-0015 is being tested in AURORAS-1, an open-label study enrolling patients with RAS-mutant solid tumors.