G1 touts PhII cancer data, but shares tank on placebo results; Merck bags another approved indication for Keytruda

→ G1 Therapeutics $GTHX tried their level best to tout the results of their Phase II study of trilaciclib in combination with topotecan for small cell lung cancer, demonstrating myelopreservation benefits. Investors, though, couldn’t get past the fact that the ORR rate was higher in the placebo group compared to their drug. The stock tanked, dropping by more than 30% on Thursday morning.

→ Pfizer and their partners at Astellas say that a Phase III study of Xtandi plus androgen deprivation therapy — ADT — in hormone-sensitive prostate cancer met the primary endpoint in radiographic progress-free survival when compared to ADT alone. “While XTANDI is currently approved for both metastatic and non-metastatic CRPC, there still remains a need for more treatment options for men with metastatic hormone-sensitive prostate cancer,” said Mace Rothenberg, who heads up Pfizer’s oncology R&D group. “With these top-line results, we believe XTANDI has the potential to help men whose disease has progressed outside the prostate gland, but still responds to treatment to lower testosterone.”

— Merck’s $MRK immunotherapy extraordinaire Keytruda won its umpteeth approval on Thursday, this time for patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC) under the accelerated approval pathway.

— Alcyone Lifesciences, which has a drug delivery platform, has tied up with Roche’s $RHBBY neurology group so the Swiss drugmaker can employ the privately-held company’s intrathecal delivery platform in developing its CNS drugs.


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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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