Sitravatinib

Bristol’s Opdivo is indicated as an adjuvant treatment for stage IIB or IIC melanoma patients. Credit: The agency photographer/Shutterstock.com. The European Commission (EC) has granted approval to Bristol Myers Squibb’s Opdivo (nivolumab) as an adjuvant treatment for stage IIB or IIC melanoma patients who have undergone complete resection. Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is used as a monotherapy in adults and adolescents aged 12 years and above. Recommended Reports Reports LOA and PTSR Model - Sitravatinib Malate in Metastatic Melanoma GlobalData Reports LOA and PTSR Model - Ribociclib Succinate in Metastatic Melanoma GlobalData View all Companies Intelligence Bristol-Myers Squibb Co IIB Corp. I I C Limited View all The approval is based on the positive results from the double-blind, randomised Phase III CheckMate -76K trial. The study compared adjuvant Opdivo 480mg given every four weeks (Q4W) against placebo for up to 12 months in stage IIB or IIC melanoma patients. Recurrence-free survival was the primary endpoint while secondary endpoints included safety, distant metastases-free survival, overall survival and progression-free survival on next-line therapy. After 7.8 months of follow-up, Opdivo was found to reduce the risk of recurrence or death by 58% compared to placebo. Its safety profile was also found to be consistent with previous studies. Bristol Myers Squibb vice-president and global programme lead Gina Fusaro stated: “With this approval, we can now offer patients in the European Union with stage IIB or IIC resected melanoma an efficacious treatment option that significantly reduced the risk of disease recurrence. “This approval builds on our long-standing commitment to bring innovative medicines to patients across the cancer spectrum, including in earlier stages of cancer.” The company also used Opdivo-based combinations, along with Opdivo, to treat earlier-stage cancer patients as part of its development programme that also included CheckMate-76K. The programme has so far treated more than 35,000 patients. In addition to stages IIB and IIC, adjuvant Opdivo is approved for treating stages III and IV resected melanoma patients.

Pictured: Man packing up his office things in a box/iStock, pcess609 Mirati Therapeutics on Tuesday announced that CEO David Meek has resigned from his post, with founder and president Charles Baum taking the company’s reins as it searches for a permanent replacement. As part of his “mutually agreed” decision to leave the company, Meek will also vacate his position on Mirati’s Board of Directors but will keep working with the biotech through Oct. 15 on a consultancy basis. “David has made a significant impact during his tenure at Mirati, most notably guiding the company through the successful launch of Krazati, the rapid advancement of our robust and innovative pipeline and the expansion of the Mirati team,” Chairman of the Board Faheem Hasnain said in a statement. In December 2022, the FDA awarded Mirati’s small molecule KRAS inhibitor Krazati (adagrasib) accelerated approval, authorizing its use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the G12C KRAS mutation. The regulatory win pitted Mirati against Amgen, whose own KRAS therapeutic Lumakras (sotorasib) was greenlit in May 2021 for the same indication. Also on Tuesday, Mirati released its second-quarter 2023 earnings results, reporting that Krazati scored a net revenue of $13.4 million. During the same period, Amgen posted net Lumakras sales of $77 million. Krazati’s figures may remain stunted in the near future after the European Medicine Agency's Committee for Medicinal Products for Human Use last month issued a negative opinion for its conditional marketing authorization. Mirati is continuing its development of Krazati including a Phase II study to push the monotherapy into the frontline setting in NSCLC and a Phase III trial testing its combination with Lilly’s EGFR blocker Erbitux (cetuximab) as a second-line treatment option for colorectal cancer. In its second-quarter update, Mirati also announced that by year-end it will initiate a Phase III study in first-line NSCLC to test the combination regimen of Krazati with Merck’s blockbuster Keytruda (pembrolizumab). Meek’s resignation also follows a late-stage blunder in May 2023, when the company announced that its investigational kinase inhibitor sitravatinib fell short of its primary efficacy bar in the Phase III SAPPHIRE study. The failure pushed Mirati to discontinue all development of sitravatinib, which in SAPPHIRE was being tested with Bristol Myers Squibb’s Opdivo (nivolumab) for non-squamous NSCLC. Following the leadership shake-up, Mirati announced it was putting $250 million worth of its common stock up for sale in an underwritten public offering. The company on Wednesday increased the aggregate gross proceeds from this offering to approximately $300 million. Mirati’s stock dipped 6% in after-hours trading. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.