Merck's women's health spinout snags mid-stage candidate for preterm birth; Keytruda nails down TNBC approval after March CRL

30 Jul 2021
endpts.com
CollaborateAccelerated Approval
Nearly two months after spinning out from Merck, women’s health business Organon has struck its first half-billion-dollar deal. Organon $OGN has promised $25 million upfront and another $475 million in biobucks for worldwide rights to ebopiprant, ObsEva’s investigational treatment for preterm labor. Ebopiprant, a selective prostaglandin F2α (PGF2α) receptor antagonist, was originally licensed from Merck KGaA in 2015. The candidate works by reducing inflammation and uterine contractions. “This development-stage asset is being studied in one of the most crucial unmet needs for women globally,” Organon CEO Kevin Ali said in a statement. There are currently no approved drugs for the acute treatment of preterm labor in the US. Back in November, ObsEva said ebopiprant reduced the delivery of pregnancies (not including twin pregnancies) by 55% at 48 hours when administered with atosiban (the ex-US standard of care), compared to atosiban alone. Overall, 12.5% of women in the treatment arm delivered babies within 48 hours of starting treatment, compared to 21.8% in the placebo arm, ObsEva said of the Phase IIa trial. “The incidence of maternal, fetal and neonatal adverse events were comparable between subjects in the ebopiprant group and the placebo group,” the company said. Organon officially spun out from Merck on June 3 with a portfolio of more than 60 medicines, including Nexplanon, its long-active reversible contraceptive. Nexplanon is one of the top hormonal contraceptives in the country, according to IQVIA data, and grew at an annual compound growth rate of 9% between 2014 and 2019. — Nicole DeFeudis Keytruda nails down TNBC approval after March CRL Merck’s blockbuster checkpoint inhibitor Keytruda has won another FDA approval, this time in a line of triple-negative breast cancer. Regulators handed down the greenlight for the treatment of patients with high-risk early-stage TNBC in combination with chemo, as neoadjuvant and then continued as a single agent as adjuvant treatment after surgery. The thumbs up marks the 30th indication for which the Keytruda is approved in the US, Merck said. Additionally, the FDA converted the Keytruda-chemo combo accelerated approval in locally recurrent unresectable or metastatic TNBC for tumors expressing PD-L1 to full approval. The TNBC approval comes after the FDA handed Merck a rare CRL for Keytruda back in March, after an adcomm unanimously voted to recommend waiting for more data for the study in question. Advisers and regulators pointed toward concerns over the trial’s event-free survival primary endpoint over placebo, saying researchers hadn’t watched patients long enough after treatment to determine EFS and OS. But a few weeks later, Merck claimed a win in the study after claiming it reached the interim analysis checkpoint. The trial, known as KEYNOTE-522, met its dual primary endpoints of event-free survival and pathological complete response. — Max Gelman
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