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CHMP Offers Positive Opinion for Perioperative Nivolumab Plus Chemo in Resectable PD-L1+ NSCLC

Frontline Fulzerasib Plus Cetuximab Elicits Deep, Durable Responses in KRAS G12C–Mutated NSCLC
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Pembrolizumab combination gets full approval in select HER2+ gastric/GEJ cancer, PSMA PET imaging agent is cleared for prostate cancer, and more from OncLive.

The FDA approved pembrolizumab, trastuzumab, and chemotherapy for HER2-positive, PD-L1–positive gastric/GEJ adenocarcinoma.

Treatment with pembrolizumab monotherapy was effective and well tolerated in pretreated patients with advanced clear cell gynecologic cancers.

The γδ T-cell agent INB-100 demonstrated a 100% relapse-free survival rate in patients with AML.

Nivolumab plus ipilimumab was approved by the European Commission for first-line, unresectable or advanced HCC.

Versamune HPV plus PDS01ADC and bintrafusp alfa demonstrated clinical benefit in locally advanced or metastatic HPV-associated cancers.

Thierry André, MD, discusses findings from the phase 3 CheckMate 8HW trial of nivolumab plus ipilimumab in MSI-H/dMMR mCRC.

The CHMP has recommended the approval of perioperative durvalumab plus neoadjuvant chemotherapy for patients with resectable NSCLC.

The top 5 videos of the week cover insights in ovarian cancer, NSCLC, CSCC, follicular lymphoma, and CLL.

Perioperative pembrolizumab sBLA gets priority review in HNSCC, nivolumab/ipilimumab sBLA in MSI-H/dMMR CRC is under review, and more from OncLive this week.

The FDA has granted priority review to the sBLA for perioperative pembrolizumab plus adjuvant radiotherapy in resectable locally advanced HNSCC.

FDA grants priority review to zongertinib in HER2-mutant NSCLC and dordaviprone for recurrent H3K27M+ diffuse glioma, and more from OncLive this week.

Petosemtamab/pembrolizumab received FDA breakthrough therapy designation for PD-L1–positive recurrent/metastatic head and neck squamous cell carcinoma.

Detalimogene voraplasmid generated complete responses in BCG-unresponsive non–muscle-invasive bladder cancer with carcinoma in situ.

CBM588 plus cabozantinib and nivolumab shows early efficacy in metastatic renal cell carcinoma.

Nivolumab plus relatlimab did not improve recurrence-free survival vs nivolumab in resected stage III/IV melanoma.

Experts highlight the top presentations to watch for at the 2025 Genitourinary Cancers Symposium.

Pembrolizumab Provides Clinical Benefit in Previously Treated Advanced Clear Cell Gynecologic Cancer
Pembrolizumab warrants further evaluation in patients with previously treated advanced clear cell gynecologic cancer in a randomized clinical trial.

The FDA granted RMAT designation to gemogenovatucel-T for maintenance treatment after frontline chemotherapy in advanced HRP ovarian cancer.

The EMA’s CHMP has adopted a positive opinion regarding frontline nivolumab plus ipilimumab in unresectable or advanced hepatocellular carcinoma.

Marcia Cruz-Correa, MD, PhD, AGAF, FASGE, discusses the FDA approval of tislelizumab with chemotherapy for advanced gastric or GEJ adenocarcinoma.

Treosulfan wins FDA approval for allHCT conditioning in AML and MDS, RP1/nivolumab gets priority review in melanoma, and more this week from OncLive.

OS was not improved with pembrolizumab plus lenvatinib and chemotherapy vs chemotherapy alone in advanced HER2-negative gastroesophageal adenocarcinoma.

The FDA granted priority review to the BLA for RP1 plus nivolumab in advanced melanoma following progression on an anti–PD-1 agent.

Sotorasib doublet gets approved for KRAS G12C–mutated CRC, acalabrutinib triplet is cleared for previously untreated MCL, and more from OncLive.





















































































