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Wednesday, December 28, 2022 7:49:29 PM
The Startling History Behind Merck's New Cancer Blockbuster
David Shaywitz Contributor
Jul 26, 2017
. . .
The pembro phase 1 program began like any other; the first-in-human study was a simple dose escalation, designed primarily to understand the safety and tolerability of the new medicine in patients with a range of advanced cancers. Efficacy was also examined in a preliminary fashion, typical for phase 1 studies. When early results suggested some melanoma patients–already suspected to be good fit for PD1 mechanism–seemed to be responding to the drug, an expansion cohort, focused entirely on advanced melanoma patients, was added.
The results from the melanoma cohort were striking. According to UCLA’s Antoni Ribas, a key investigator in this advanced melanoma study:
Among the first 7 patients we enrolled, 6 patients had objective responses. I realized I was probably lucky and this high rate of responses would not hold up forever, but also realized that [pembro] was different from all the other cancer immunotherapy we had tested to date, all of which had response rates in the 10-15% range.
Ribas then started sending before and after scans to the Merck team running the study, urging them to share with upper management. He worried Merck was “going too slow in recognizing how important this was.”
Merck scientists involved in the program tell me they needed little prodding from Ribas, saying they were acutely aware of the both the potential clinical utility of their drug and the commercial need to close the gap with a competitor who seemed to be years ahead.
https://www.forbes.com/sites/davidshaywitz/2017/07/26/the-startling-history-behind-mercks-new-cancer-blockbuster/?sh=24fa0bfa948d
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