An early-stage study shows Bristol-Myers Squibb Co’s Opdivo treatment can be safely and effectively paired with relatively low and infrequent dosages of the company’s other immunotherapy, Yervoy, for patients with previously untreated lung cancer, researchers said on Monday.
Opdivo, whose chemical name is nivolumab, is approved to treat advanced melanoma and the less-common squamous type of non-small cell lung cancer. In a recent late-stage study, it improved survival compared with chemotherapy in previously treated patients with the more common non-squamous form of lung cancer.
To bolster the effectiveness of Opdivo, Bristol-Myers is testing it in combination with Yervoy, which is approved to treat melanoma and, like Opdivo, takes the brakes off the immune system.
Company researchers on Monday released updated data from a Phase I study, called Check Mate-12, that involved 148 previously untreated patients with squamous and non-squamous lung cancer. It compared results of four available drug regimens that paired Opdivo and Yervoy.
In melanoma studies, Opdivo’s effectiveness has been greatly enhanced by adding Yervoy, but with a worrisome increase in side effects.
Yervoy, typically taken in 3 milligram doses every three weeks for melanoma, in the lung cancer trial was given at a 1 milligram dose every six weeks in one arm of the study, and at 1 milligram every 12 weeks in another arm. It was taken with 3 milligram doses of Opdivo every two weeks, the way it is used against melanoma and previously treated squamous lung cancer.
Some 39 percent of patients taking Opdivo plus Yervoy every 12 weeks saw some reduction in tumors, similar to the 31 percent reduction for those taking Yervoy every 6 weeks.
Importantly, 10 percent or fewer of patients in the two arms dropped out of the study because of side effects, little different from those who have taken Opdivo alone in other study arms and half the dropout rate seen among patients that have taken Opdivo with chemotherapy.
“A well tolerated regimen has been achieved, with ability to maintain the additive benefit of (Yervoy)” to Opdivo, Michael Giordano, head of Bristol-Myers’ immuno-oncology program, said in an interview.
Opdivo and a similar treatment from Merck & Co called Keytruda block a protein called PD-1 whose natural function is to put checks on the immune system. Wall Street expects such drugs to capture combined annual sales of over $20 billion by 2020.
Results of the study were released at the World Conference on Lung Cancer being held in Denver.