Immuno-Oncology

Clonal neoantigen load was significantly associated with promising responses to PD-1/PD-L1 and CTLA-4 combination therapy in RCC.

Here is your Q2 2025 preview spotlighting 7 FDA decisions to watch, including upcoming PDUFAs for nivolumab/ipilimumab, belzutifan, UGN-102, avutometinib/defactinib, and more.

Durvalumab has received perioperative approval in the European Union in patients with resectable non–small cell lung cancer based on data from AEGEAN.

Here is your snapshot for all therapeutic options that were approved by the FDA in March 2025 spanning tumor types.

Tisotumab vedotin was granted approval by the EU for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

María-Victoria Mateos, MD, PhD, discusses long-term OS data from the CARTITUDE-4 trial of cilta-cel in lenalidomide-refractory multiple myeloma.

Updated KEYNOTE-799 data continued to show robust activity with pembrolizumab plus concurrent chemoradiation in unresectable stage III NSCLC.

The FDA cleared therapeutic options in pNETs/epNETs, MIBC, and mCRPC; experts highlight top abstracts ahead of 2025 EBMT; and more from OncLive.

The FDA approved perioperative durvalumab plus chemotherapy for muscle-invasive bladder cancer.

The EMA’s CHMP has recommended the approval of perioperative nivolumab plus chemotherapy in resectable PD-L1–positive non–small cell lung cancer.

Fulzerasib plus cetuximab elicited deep efficacy in patients with KRAS G12C–mutated NSCLC enrolled in the phase 2 KROCUS study.

Adagrasib plus pembrolizumab continued to show promising efficacy in patients with KRAS G12C–mutated NSCLC and PD-L1 TPS of 50% or higher.

The development of nemvaleukin in platinum-resistant ovarian cancer will be discontinued based on interim OS data from the phase 3 ARTISTRY-7 trial.

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.