Two Pembrolizumab Trials in Head and Neck Cancer Yield Divergent Results
Two first-line trials involving pembrolizumab (Keytruda)-based combinations for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) delivered mixed results. While first-line pembrolizumab plus lenvatinib (Lenvima) significantly improved progression-free survival (PFS) and overall response rate (ORR) compared with pembrolizumab alone in patients with recurrent or metastatic HNSCC with PD-L1 combined positive […]
A Win and A Loss for Adjuvant ICIs in Clear Cell Renal Cell Carcinoma
SAN FRANCISCO — The use of adjuvant pembrolizumab (Keytruda) boosted overall survival (OS) in post-surgical patients with clear cell renal cell carcinoma (RCC) at risk for recurrence, according to KEYNOTE-564 findings. Patients treated with the immune checkpoint inhibitor (ICI) had a 38% reduced risk of death compared to patients on placebo, reported Tony Choueiri, MD, […]
Pembrolizumab in First-Line Boosts PFS in HER2-Positive Stomach Cancer
MADRID — Including pembrolizumab (Keytruda) in the first-line treatment of metastatic HER2-positive gastric or gastroesophageal cancer improved progression-free survival (PFS), but potential harm was seen in PD-L1-negative patients, the randomized KEYNOTE-811 trial showed. In patients receiving standard chemotherapy plus trastuzumab, median PFS improved from 8.1 months with placebo to 10.0 months with pembrolizumab (HR 0.73, […]
New Data in NSCLC Bolster Support for Perioperative Immunotherapy
CHICAGO — A randomized trial testing the addition of perioperative pembrolizumab (Keytruda) to chemotherapy in operable non-small cell lung cancer (NSCLC) hit one of its two primary endpoints in an interim analysis, with a favorable trend for the other. All patients in the study received cisplatin-based neoadjuvant chemotherapy, and at 2 years, the event-free survival […]
‘Fantastic,’ ‘Terrific’ Results With Oncolytic Virus Combo for Bladder Cancer
CHICAGO — An oncolytic virus therapy combined with pembrolizumab (Keytruda) produced complete responses (CRs) in 85% of patients with bacillus Calmette-Guérin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC), a small phase II trial showed. The results showed CRs in 29 of 34 patients with detectable carcinoma in situ (CIS) treated with cretostimogene grenadenorepvec (CG0070) and the PD-1 […]
FDA Greenlights New First-Line Regimen in Bladder Cancer
The FDA gave accelerated approval to enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) as first-line treatment for certain patients with locally advanced or metastatic urothelial cancer, the agency announced on Monday. Specifically, the combination is indicated for those who are ineligible for cisplatin-containing chemotherapy, and the approval marks the first anti-PD-1/antibody-drug conjugate combination for this patient […]
Pembrolizumab Active in BCG-Unresponsive Papillary High-Risk Bladder Cancer
SAN FRANCISCO — Pembrolizumab (Keytruda) monotherapy showed encouraging antitumor activity in patients with papillary high-risk non-muscle-invasive bladder cancer (HR NMIBC) that was unresponsive to Bacillus Calmette-Guerin (BCG) treatment. In a cohort of patients in the KEYNOTE-057 study who had 45 months of follow-up, those treated with pembrolizumab (n=32) had an estimated 12-month disease-free survival (DFS) […]
Modest Survival Gain in Gastric/GEJ Cancer With Chemo Plus Pembrolizumab
Adding pembrolizumab (Keytruda) to chemotherapy modestly improved survival in unresectable/metastatic gastric or gastroesophageal junction (GEJ) cancer, a randomized trial showed. Median overall survival (OS) improved from 11.5 months with chemotherapy alone to 12.9 months with the addition of the immune checkpoint inhibitor. Median progression-free survival (PFS) improved from 5.6 months to 6.9 months. Landmark survival […]
Three Adjuvant Immunotherapy Trials Flop in Renal Cell Carcinoma
PARIS — While pembrolizumab (Keytruda) has been approved as an adjuvant treatment for patients with high-risk renal cell carcinoma (RCC), three phase III studies presented at the European Society for Medical Oncology (ESMO) annual congress here failed to support the immune checkpoint inhibitor in this setting. In Part A of the CheckMate-914 trial, the median […]
Keytruda Plus T-VEC Falls Short in Unresectable Melanoma
Pembrolizumab (Keytruda) plus intratumoral talimogene laherparepvec (T-VEC, Imlygic) did not significantly improve survival in unresectable melanoma as compared with pembrolizumab alone, an international phase III trial showed. Although the combination improved median progression-free survival (PFS) by almost 6 months (14.3 vs 8.5 months), the difference did not achieve statistical significance (P=0.13). Median overall survival (OS) […]