Jordyn Sava is an editor for Targeted Oncology.
OnPrime Study of Olvi-Vec, Platinum-Doublet, and Bevacizumab Initiates in Ovarian Cancer
September 26th 2022Based on preclinical studies which have shown the clinical benefit of Olvi-Vec, a phase 3 trial evaluating the agent in combination with platinum-doublet chemotherapy and bevacizumab has commenced in patients with platinum-resistant/refractory ovarian cancer.
ODAC Votes Against Melphalan Flufenamide in R/R Multiple Myeloma
September 22nd 2022Due to the potential detriment in overall survival, its failure to demonstrate a progression-free survival benefit, and the lack of a known appropriate dose, ODAC has voted that melphalan flufenamide is not favorable in relapsed/refractory multiple myeloma.
Phase 1b Expansion Study of PY159 Doses First Patient With Ovarian Cancer
September 21st 2022Enrollment has begun in the phase 1b trial examining PY159 alone and in combination with pembrolizumab in patients with unresectable and/or metastatic solid tumors that are refractory or relapsed to standard of care.
Study of DZD9008 Meets Primary End Point of ORR in EGFR Exon20Ins-Positive NSCLC
September 14th 2022Topline data presented at ESMO 2022 showed DZD9008 met its primary end point of objective response rate and had a benign safety profile in non–small cell lung cancer with EGFR exon 20 insertion mutations.
FDA Clears Phase 1/2 Study of ABT-101 in Non–Small Cell Lung Cancer
September 14th 2022The FDA has granted approval for an investigational new drug protocol amendment for ABT-101, a mutant selective tyrosine kinase inhibitor which has shown superior selectivity against HER2 exon 20 mutations in NSCLC in preclinical studies.
Darovasertib/Crizotinib Demonstrates Efficacy in Metastatic Uveal Melanoma
September 13th 2022With an overall response rate of 50% and greater than 5 months median progression-free survival in patients with first-line metastatic uveal melanoma, darovasertib and crizotinib shows a compelling clinical efficacy profile.
sNDA Submitted to the FDA for Rucaparib in Advanced Ovarian Cancer
September 13th 2022Data from the monotherapy analysis of the phase 3 ATHENA trial has led to the submission of a supplemental new drug application to the FDA and EMA for rucaparib as treatment for patients with advanced ovarian cancer.
Abemaciclib Plus Aromatase Inhibitors Shows Improved OS in HR+/HER2- Breast Cancer
September 9th 2022Updated findings of the MONARCH 3 trial of abemaciclib added to a nonsteroidal aromatase inhibitor presented at ESMO 2022 revealed prolonged overall survival in hormone receptor-positive, HER2-negative breast cancer.
Sintilimab Plus Chemotherapy Elicits PFS Benefit in EGFR-mutated Non-Squamous NSCLC
September 8th 2022Findings from the phase 3 ORIENT-31 study shows improved progression-free survival with sintilimab with or without bevacizumab biosimilar injection and chemotherapy in EGFR-mutated non-squamous non-small cell lung-cancer.