Bristol pairs Yervoy
safely with Opdivo vs lung cancer
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[September 08, 2015]
By Ransdell Pierson
(Reuters) - 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.
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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.
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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.
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"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.
(Reporting by Ransdell Pierson; Editing by Richard Chang)
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