Healthcare Roundup – Bristol Myers announce new late-stage data for Opdivo/ Cabometyx combo in kidney cancer; Merck antiviral molnupiravir effective in preventing COVID-19 in lung tissue

Published on: February 10, 2021
Author: Amy Liu

Bristol Myers announce new late-stage data for Opdivo/ Cabometyx combo in kidney cancer

Bristol Myers Squibb (NYSE: BMY) and Exelixis, Inc. (NASDAQ:EXEL)disclosed new data for Opdivo/ Cabometyx combo in a pivotal Phase 3 trial for the first-line treatment of advanced renal cell carcinoma.

The trial sponsored by Bristol Myers Squibb and Ono Pharmaceutical(OTC:OPHLF) and co-funded by Exelixis, Ipsen (OTCPK:IPSEF), and Takeda Pharmaceutical (NYSE:TAK) evaluate the safety and efficacy of combination doublet compared to sunitinib for the indication.

The primary endpoint is progression-free survival (“PFS”), while the secondary endpoints include overall survival (“OS”) and objective response rate (“ORR”).

PFS: The combination doubled median PFS (17.0 months vs. 8.3 months, respectively; HR 0.52; 95% CI: 0.43 to 0.64) vs sunitinib.

ORR: Nearly twice as many patients responded to the combination vs. sunitinib (54.8% vs. 28.4%).

OS: The drug combination maintained the OS improvement, with a 34% reduction in the risk of death compared to sunitinib (HR: 0.66; 95% CI: 0.50 to 0.87).

After a median follow-up of two years (23.5 months), no new safety signals were identified.

“These new findings from CheckMate -9ER and the recent FDA approval of the combination regimen are extremely encouraging as we further explore the potential of CABOMETYX in combination with immunotherapies to help more patients with difficult-to-treat tumor types,” said Gisela Schwab, chief medical officer of Exelixis.

Last month, the FDA approved Opdivo/ Cabometyx for the first-line treatment of patients with advanced renal cell carcinoma.

Merck antiviral molnupiravir effective in preventing COVID-19 in lung tissue

Researchers at the University of North Carolina say that molnupiravir, under development from Merck (NYSE:MRK) and Ridgeback Biotherapeutics, is effective at preventing and treating COVID-19 based on an in vivo model containing human lung tissue.

The research, published in the journal Nature, finds that molnupiravir, also known as EIDD-2801, stops the replication of SARS-CoV-2, and prevents infection in human cells.

“We found that EIDD-2801 had a remarkable effect on virus replication after only two days of treatment — a dramatic, more than 25,000-fold reduction in the number of infectious particles in human lung tissue when treatment was initiated 24 hours post-exposure,” senior author J. Victor Garcia, Ph.D., said.

Molnupiravir is currently undergoing trials in both phase 2 and 3.

Merck shares are down 0.5% to $74.69 in morning trading.

Cannabis stocks surge amid Tilray U.K. Pact, Canopy’s robust Q3 sales

Marijuana stocks are up in premarket trading on the heels of Tilray(NASDAQ:TLRY) signing a pact to distribute medical cannabis products in U.K. and Canopy Growth’s (NYSE:CGC) fiscal Q3 revenue beat.

Related names: Aurora Cannabis (NYSE:ACB) +5.4%, Hexo(NYSE:HEXO) +4.8%, Aphria (NASDAQ:APHA) +12.8%, Cronos Group(NASDAQ:CRON) +2.8%, OrganiGram Holdings (NASDAQ:OGI) +10%.

The broader indexes also surged with, pot ETF ETFMG Alternative Harvest (NYSEARCA:MJ) up about 6% whereas Global X Cannabis ETF (NASDAQ:POTX) soars 8%. Spinnaker Cannabis ETF(NYSEARCA:THCX) rises 8.2%.

Gains in the cannabis sector were spurred after Jazz Pharmaceuticals announced its plans to buy medical cannabinoid firm GW Pharma for $7.2B.

Cannabis ETF Global X is torching its peers, up 85% so far in 2021

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