Results from the pivotal phase III MONALEESA-2 study show LEE011 (ribociclib) plus letrozole significantly extended progression-free survival (PFS), compared to a standard of care, letrozole, as a first-line treatment in postmenopausal women with hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (median PFS, 95% CI (19.3 months - not reached) vs 14.7 months (13.0 - 16.5 months); HR=0.556; p=0.00000329.
A retrospective analysis of the PEAK study in mCRC patients with RAS wild-type primary tumors of left-sided origin showed that patients receiving Vectibix plus FOLFOX6 as first-line treatment achieved 43.4 months median overall survival (OS), an increase of 11.4 months when compared to FOLFOX6 plus bevacizumab.
Updated results of the phase I CheckMate-016 trial include findings for the Opdivo (sunitinib) and Yervoy (pazopanib) combinations showed the overall response rate (ORR; secondary endpoint) was 40.4% (n=47) in both arms.
Results from the CheckMate -275 trial, in which Opdivo confirmed objective response rate (ORR), the primary endpoint, of 19.6% (95% CI 15.0 – 24.9) in platinum-refractory patients with metastatic urothelial carcinoma, said Bristol-Myers Squibb, the drug's sponsor.
In addition, Opdivo more than doubled the time to deterioration for most functional domains measured and significantly delayed the time to worsening symptoms of fatigue, dyspnea and insomnia, compared to investigator's choice of therapy, the company said.
Distant metastasis-free survival, a secondary endpoint, was also significantly improved versus placebo (HR=0.76 [95.8% CI: 0.64-0.92; p=0.002]) and had five-year DMFS rates of 48.3% and 38.9% in the Yervoy and placebo groups, respectively.
Genentech said its pivotal phase III OAK study of Tecentriq (atezolizumab) showed a median survival of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 - 0.87).
FDA has recommended against the use of ovarian cancer screening tests, regardless of risk level.
The National Cancer Institute Cancer Therapy Evaluation Program approved the following clinical research studies for August. For further information, contact the principal investigator listed.
FDA granted Breakthrough Therapy designation to LEE011 (ribociclib), in combination with letrozole, for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. LEE011 is a selective cyclin dependent kinase (CDK4/6) inhibitor.
