Afuresertib Plus Paclitaxel Fails to Improve Survival in Platinum-Resistant Ovarian Cancer Trial
• Phase 2 PROFECTA-II/GOG-3044 trial shows afuresertib plus paclitaxel did not significantly improve progression-free or overall survival compared to paclitaxel alone in platinum-resistant ovarian cancer patients.
• Biomarker analysis suggests patients with higher pAKT expression (>1) may benefit more from the combination therapy, with median PFS of 5.4 months versus 2.9 months with paclitaxel alone.
• The combination therapy demonstrated a manageable safety profile but had higher rates of diarrhea (64.6% vs 19.1%) and more frequent treatment discontinuations (20.2% vs 6.4%) compared to paclitaxel monotherapy.
Faeth Therapeutics Advances Novel Three-Pronged Approach for Metabolism-Driven Cancers with Promising Preclinical Results
• Faeth Therapeutics has published preclinical proof-of-concept data in the British Journal of Cancer supporting their multi-node PIKTOR approach, which combines dual PI3K/AKT/mTOR pathway inhibitors with an insulin-suppressing diet.
• The company's strategy targets cancer metabolism through simultaneous inhibition of multiple pathway nodes, showing tumor regression in endometrial and breast cancer models while potentially overcoming common resistance mechanisms.
• A Phase 2 trial in collaboration with The GOG Foundation is currently underway for patients with endometrial cancer, building on earlier clinical data that demonstrated an 80% objective response rate with the drug combination.
Corcept Therapeutics Submits New Drug Application for Relacorilant to Treat Cushing's Syndrome
• Corcept Therapeutics has submitted a New Drug Application to the FDA for relacorilant, a selective cortisol modulator designed to treat patients with endogenous hypercortisolism (Cushing's syndrome).
• The application is supported by positive results from multiple clinical trials, including the pivotal GRACE trial, Phase 3 GRADIENT study, and long-term extension studies, demonstrating improvements in various symptoms with an acceptable safety profile.
• Relacorilant showed no instances of serious adverse events common in current treatments, such as drug-induced adrenal insufficiency, hypokalemia, or QT prolongation, positioning it as a potential new standard of care.
KEYTRUDA Plus Chemoradiotherapy Improves Overall Survival in High-Risk Cervical Cancer
• KEYNOTE-A18 trial shows KEYTRUDA (pembrolizumab) plus chemoradiotherapy significantly improves overall survival in high-risk, locally advanced cervical cancer patients.
• The KEYTRUDA regimen reduced the risk of death by 33% compared to chemoradiotherapy alone, establishing a potential new standard of care.
• The 36-month overall survival rate was 82.6% with KEYTRUDA plus chemoradiotherapy versus 74.8% with chemoradiotherapy alone.
• The safety profile of KEYTRUDA in combination with chemoradiotherapy was consistent with previous studies, with no new safety signals identified.
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