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Re: DewDiligence post# 210387

Monday, 04/03/2017 12:14:58 PM

Monday, April 03, 2017 12:14:58 PM

Post# of 252340
Like the proposition of approval. Thanks for the detailed explanation.

Also saw the indication of more adverse reactions:
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Opdivo, Yervoy combo scores higher survival rate for melanoma, with worse adverse events
Bristol-Myers, which has been working on bolstering its case for a combination of Opdivo and Yervoy in treating cancer, also turned up at AACR with new data that highlights improved survival rates for melanoma rates.

James Larkin, Oncologist

Oncologist James Larkin and colleagues enrolled 945 first-line patients with advanced melanoma and randomly assigned them in equal groups to nivolumab plus ipilimumab, nivolumab, or ipilimumab.

After a minimum follow-up of 28 months, investigators reported, median overall survival among those patients randomly assigned ipilimumab was 20 months. The median OS had not been reached for the nivolumab plus ipilimumab or the nivolumab plus placebo arms.

A total of 64% in the combo arm achieved two-year survival, the highest rate. The rate was 59% and 45% among those randomly assigned nivolumab plus placebo and ipilimumab alone. But the combo arm also experienced worse adverse events.

Researchers added:

A similar trend was seen for median duration of response. Median duration of response had not been reached in the nivolumab plus ipilimumab arm, while it was 31.1 months and 18.2 months for the nivolumab plus placebo arm and ipilimumab alone arm, respectively. In descriptive analyses, meaning the study was not powered for this comparison, patients randomly assigned nivolumab plus ipilimumab had a 12 percent lower risk of death compared with those randomly assigned nivolumab plus placebo.

“It is exciting to see that initial results suggest that the nivolumab plus ipilimumab combination provides favorable survival outcomes compared with ipilimumab alone,” said Larkin. “However, the combination also results in a higher rate of severe adverse events than nivolumab or ipilimumab alone, so it is important to consider this when making treatment decisions for patients.”
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https://endpts.com/aacr17-roundup-bristol-myers-merck-kgaa-and-pfizer-in-the-spotlight-marking-progress-with-checkpoints/

BMY

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