Head and Neck Cancers

Opdivo Extends OS in Phase III Squamous Cell Carcinoma Trial

A phase III trial of PD-1 inhibitor Opdivo showed significant survival benefit at one year—compared to investigator’s choice of methotrexate, docetaxel or cetuximab—in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

Patients treated with Opdivo (nivolumab) experienced a 30 percent reduction in the risk of death, with a median overall survival of 7.5 months (95% CI: 5.5-9.1) compared to 5.1 months (95% CI: 4.0-6.0) for investigator’s choice (HR=0.70 [97.73% CI: 0.51-0.96] p=0.0101).

The one-year survival rate for Opdivo was 36 percent compared to 16.6 percent for investigator’s choice. The safety profile of Opdivo in CheckMate-141 was consistent with prior studies, with no new safety signals identified.

Melanoma

Opdivo-Yervoy Combination Demonstrates Two-Year Survival Rate of 69 Percent

Overall survival data from CheckMate-069, a phase II trial of a Opdivo and Yervoy combination regimen in patients with previously untreated advanced melanoma, demonstrated a two-year overall survival rate of 69 percent compared to 53 percent for Yervoy alone (HR=0.58 [95% CI: 0.31-1.08]) in patients with BRAF wild-type advanced melanoma.

CheckMate-069 evaluated 142 patients with previously untreated unresectable or metastatic melanoma who received either the Opdivo and Yervoy combination regimen (n=95) or Yervoy alone (n=47). The trial included patients with BRAF wild-type and BRAF V600 mutation-positive melanoma, and randomization was stratified by BRAF mutation status.

Drugs and Targets

FDA Grants Accelerated Approval To Venclexta Tablets in CLL

FDA granted accelerated approval to Venclexta tablets (venetoclax) for patients diagnosed with chronic lymphocytic leukemia with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.

The indication was approved based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Also:

• Approvals of Gilotrif and two-dose Gardasil 9, an FDA draft guidance for biosimilars, and more 

Ovarian Cancer

• Phase III Farletuzumab Trial Fails to Meet Survival Endpoints

• Array BioPharma Stops Phase III MILO Trial in Serous Ovarian Cancer

Prostate Cancer

Study: SBRT Delivers 98.6% Cure Rate at Five-Year Followup

Soft Tissue Sarcoma

Researchers: Radiation After Surgery Benefits Older Patients More than Younger Patients

NCI CTEP-Approved Trials for the Month of April

Letter to the Editor

GOG Foundation Sends Rebuttal Letter to Oncolytics Biotech