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 […]
Cabozantinib Plus Atezolizumab Delays Progression in mCRPC
SAN FRANCISCO — In patients with metastatic castration-resistant prostate cancer (mCRPC) whose disease progressed on a novel hormonal therapy, the combination of cabozantinib (Cabometyx) plus atezolizumab (Tecentriq) improved radiographic progression-free survival (rPFS) versus a switch to a second hormonal agent, a phase III trial showed. The so-called CONTACT-02 study included patients with extrapelvic nodal or […]
Combination Shows Promise in Metastatic ESR1-Mutant Breast Cancer
A novel drug combination led to clinically meaningful antitumor activity in metastatic ESR1-mutated, estrogen receptor-positive (ER+)/HER2-negative breast cancer that had progressed on CDK4/6 inhibition, a small prospective study showed. Adding the selective estrogen receptor modulator (SERM) lasofoxifene to abemaciclib (Verzenio) resulted in a median progression-free survival (PFS) of 56 weeks, and a 24-week clinical benefit […]
FDA Approves New First-Line Standard of Care in Bladder Cancer
Patients with locally advanced or metastatic bladder cancer have a permanent new first-line standard of care after the FDA granted full approval to the combination of enfortumab vedotin (Padcev) and pembrolizumab (Keytruda) regardless of cisplatin eligibility. The action finalized the approval process for the combination, which received accelerated approval earlier this year, at the time […]
Clinical Challenges: Sequencing in Metastatic, HER2-Positive Breast Cancer
In the last few years there has been tremendous progress in the treatment of metastatic HER2-positive breast cancer. “We are getting a lot of therapeutic options coming into this space,” said Shridar Ganesan, MD, PhD, a physician-scientist at the Rutgers Cancer Institute of New Jersey. “Trastuzumab [Herceptin] was the first, but we now have a […]
Radionuclide Therapy Tops AR-Pathway Inhibitor Switch for mCRPC
MADRID — Radiographic progression-free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) doubled when patients received a radionuclide ligand targeting prostate-specific membrane antigen (PSMA) instead of switching to another androgen receptor pathway inhibitor (ARPI), a randomized trial showed. In patients with prior progression on an ARPI, median rPFS increased from 5.9 months with another ARPI […]
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, […]
Adding Regorafenib in First-Line ‘Promising’ in Gastric Cancer
Adding regorafenib (Stivarga) to a standard first-line chemoimmunotherapy regimen for HER2-negative metastatic esophagogastric cancer demonstrated “promising” activity in a single-arm phase II study, according to researchers. Among 35 evaluable patients treated with the tyrosine kinase inhibitor (TKI) plus nivolumab (Opdivo) and FOLFOX chemotherapy, 25 (71%, 95% CI 54-85) remained progression free at 6 months, thus […]
FDA Staff Not Sold on Broad Olaparib Indication in Metastatic CRPC
Olaparib (Lynparza) plus abiraterone (Zytiga) as initial treatment for metastatic castration-resistant prostate cancer (CRPC) is only clearly effective in patients with BRCA mutations, FDA staff contended in a briefing document released ahead of an advisory committee meeting. On Friday, the FDA is asking its Oncologic Drugs Advisory Committee (ODAC) to weigh in on whether a […]
KRAS Mutations in Metastatic CRC Predict Survival Benefit of Chemo Combo
Codon-specific KRAS mutations are predictive of an overall survival (OS) benefit for metastatic colorectal cancer (mCRC) patients treated with trifluridine-tipiracil (FTD/TPI; Lonsurf), according to a genomics-based analysis. After identifying biomarkers of resistance and validating the findings in a real-world dataset, researchers showed that patients with KRAS G12-mutant tumors in the phase III RECOURSE trial achieved […]