The FDA granted breakthrough therapy designation to subcutaneous amivantamab for recurrent or metastatic HPV-unrelated HNSCC after progression on platinum-based chemotherapy and a PD-1/PD-L1 inhibitor. The decision was supported by OrigAMI-4 cohort 1 data showing a 45% ORR and 76% clinical benefit rate.
AstraZeneca reported strong Q1 2026 results with 8% revenue growth and 12% operating profit growth, driven by its oncology portfolio and pipeline progress. The company also saw unusual options activity and maintained full-year guidance. Key oncology brands including Imfinzi and Enhertu showed double-digit growth.
Relay Therapeutics reported Q4/FY 2025 results, outlined 2026 milestones for zovegalisib, and held ~$555M in cash. Initial vascular anomaly data and breast cancer triplet data are expected in 2026.
A phase 3 trial of azacitidine and chidamide plus CHOP in untreated PTCL showed a significant overall survival improvement but no significant gains in response rate or progression-free survival. The study suggests molecular profiling could guide future therapies.
Nuvation Bio reported updated Phase 2 data for safusidenib in IDH1-mutant glioma with a 52% ORR and 79% 36-month PFS rate. The company is expanding its clinical program with two new studies and expanding the SIGMA trial to a pivotal Phase 3, aiming to address broader patient populations.
Six-year SEQUOIA trial data show zanubrutinib sustains a progression-free survival advantage (74% vs 32%) over bendamustine-rituximab in CLL without del(17p). Benefit extends to high-risk del(17p) patients.
The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
A phase 2 trial showed neoadjuvant pembrolizumab achieved a 71% pathological complete response rate in resectable desmoplastic melanoma. A real-world study found ipilimumab monotherapy after anti-PD-1 progression yielded an ORR of 10.8% and median OS of 7.6 months in advanced melanoma.
Epcoritamab plus lenalidomide cut progression risk by 60% in R/R DLBCL in a phase 3 trial. Five-year AUGMENT follow-up supports R2 in indolent NHL; a phase 2 penpulimab-lenalidomide-R-GemOx trial showed activity in DLBCL.
Pfizer reported positive topline PFS results for encorafenib plus cetuximab and FOLFIRI in BRAF V600E-mutant mCRC from BREAKWATER cohort 3. The regimen showed significant PFS improvement and clinically meaningful OS benefit, with no new safety signals.
