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.
A new class of drugs called HIF-2 inhibitors is more effective and better tolerated than the standard of care drug sunitinib in treating kidney cancer, researchers with the Kidney Cancer Program at Harold C. Simmons Comprehensive Cancer Center have found.
Celsion Corp. said NIH has conducted an independent retrospective analysis of data from the intent-to-treat population of the Company's HEAT Study, a 701-patient study investigating ThermoDox, Celsion's proprietary heat-activated liposomal encapsulation of doxorubicin in combination with radiofrequency ablation in primary hepatocellular carcinoma.