Cancer Drug Findings

Bristol-Myers Squibb (New York, NY) announced in early September 2017 a successful phase 3 study of a combination therapy to improve overall survival in kidney cancer.

The company tested a combination of its drugs Opdivo (nivolumab) and Yervoy (ipilimumab), which demonstrated better overall survival rates than a standard-of-care drug (Pfizer’s SUTENT (sunitinib malate) in previously untreated patients with advanced or metatstatic renal cell carcinoma.

Bristol-Myers Squibb said the study was stopped early after a reduction in tumor size was noted in patients as part of a planned interim analysis. The combination treatment did not improve progression-free survival, but the trial did reduce tumor size in patients. Analysts from Barclays, quoted by Reuters, said the trial “provides perhaps the most explicit evidence to date that progression-free survival may not be the best yardstick to measure the benefit of immunology-oncology drugs.”

The cancer drug bosutinib (Bosulif), under development by Pfizer, with research headquarters in Groton, CT, slowed cyst growth in patients with autosomal dominant polycystic kidney disease (ADPKD), according to a phase 2 clinical trial.

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The drug is a kinase inhibitor indicated for the treatment of adult patients with differing forms of chronic myelogenous leukemia (CML) who have resistance or intolerance to prior therapy, according to prescribing information for the drug.

After two years of treatment, the annual rate of kidney enlargement was reduced by 66% in patients taking bosutinib 200 mg/day versus placebo (1.63% versus 4.74% per year, p = 0.01), according to findings reported in the Journal of the American Society of Nephrology (JASN 2017; doi:10.1681/ASN.2016111232).

Patients who took bosutinib at 400 mg/day had an even higher reduction in the rate of enlargement versus placebo (1.29% versus 4.74% per year). According to a protocol amendment for the trial, doses for 24 patients who initially received bosutinib at 400 mg/day were later reduced to 200 mg/day. Gastrointestinal and liver-related side effects were most common, but overall toxicity was consistent with the profile in prior studies of bosutinib, and no new toxicities were identified.

October/November 2017 (Vol. 9, Number 10 & 11)