A first analysis of Bristol Myers Squibb Co. and Nektar Therapeutics Inc.’s phase III melanoma study shows it missed three primary endpoints. The study of bempegaldesleukin combined with Opdivo (nivolumab) vs. Opdivo monotherapy as a first-line treatment for previously untreated unresectable or metastatic melanoma did not meet the primary endpoints of progression-free survival (PFS) and objective response rate. An independent data monitoring committee also said the third primary endpoint of overall survival (OS) did not meet statistical significance at the first interim analysis. The trial will be unblinded and there will be no additional analyses for the OS endpoint. Nektar stock (NASDAQ:NKTR) dropped 62% by midday.
Pathway phase III wins for Ascendis in hypoparathyroidism
Ascendis Pharma A/S unveiled positive top-line data from the Pathway phase III study testing Transcon PTH, a prodrug of parathyroid hormone (PTH) as a once-daily hormone replacement therapy for adults with hypoparathyroidism (HPT). The compound turned up statistically significant improvement on the primary composite endpoint – normal serum calcium and independence from conventional HPT therapy – as well as all key secondary endpoints. Shares of the Copenhagen-based firm (NASDAQ:ASND) were trading midday at $100.20, down $1.98, or 1.94%.
Bridgebio reports positive phase II data in rare disease LGMD2i
Bridgebio Pharma Inc. cited improvements in functional endpoints in its phase II study testing BBP-418 (ribitol) in patients with limb-girdle muscular dystrophy type 2 (LGMD2i) and said it plans to meet with regulators to design a phase III registrational study to start this year. The phase II study in LGMD2i, presented at the Muscular Dystrophy Association meeting, is one of several clinical readouts expected in 2022, as the Palo Alto, Calif.-based company looks to regain its footing after disappointing top-line data for its phase III program in transthyretin amyloid cardiomyopathy leveled the stock late last year.
Europe cutting research links with Russia, Belarus over Ukraine war
Russia and Belarus are being frozen out of international science, with universities and research institutions across Europe suspending joint research projects and calling a halt to the formation of any new collaborations, following the invasion of Ukraine. Initial sanctions announced by European governments called for the severing of direct institution-to-institution links only, with many universities counselling individual researchers to maintain personal relations with Russian peers.
Future of biologics competition could rest in PBMs' hands
2023 may be a pivotal year for biosimilars in the U.S. with a number of approved Humira (adalimumab) biosimilars set for staggered launches under agreements with Abbvie Inc. How successful those launches are, especially the one for Boehringer Ingelheim GmbH’s interchangeable, Cyltezo, will be determined in large part by three pharmacy benefit managers that together set the prescription drug formularies for nearly 80% of Americans covered by Medicare and private insurance. If those PBMs refuse to include the discounted biosimilars or interchangeables on their preferred formularies, they could undermine the competition that Congress envisioned when it passed the Biologics Price Competition and Innovation Act and chill the development of future biosimilars and interchangeables.
Sanofi’s shares hit as amcenestrant fails in phase II breast cancer trial
Sanofi SA has suffered a setback in its bid to find a successor to Astrazeneca plc’s breast cancer drug Faslodex (fulvestrant) as amcenestrant failed to improve progression-free survival (PFS) in advanced breast cancer in a mid-stage trial. Nonetheless, amcenestrant, a potential next-generation oral selective estrogen receptor degrader (SERD), could still be a significant source of income for Paris-based Sanofi and is being tested in several studies.
SEC identifies firms for tougher audits, including three biopharmas
The U.S. Securities and Exchange Commission (SEC) recently issued a provisional list of five U.S.-listed Chinese companies that reportedly failed to submit necessary accounting reports required under Holding Foreign Companies Accountable Act (HFCAA). The list included three biopharmas: Beigene Ltd., Hutchmed Ltd., and Zai Lab Ltd. The two remaining companies are restaurant company Yum China Holdings Inc. and ACM Research Shanghai Inc. All five companies saw meaningful drops in both their U.S. and Hong Kong shares.
Pfizer authorizes China Meheco Group rights to commercialize Paxlovid in China
Chinese state-owned enterprise China Meheco Group Co. Ltd. has signed a deal with Pfizer Inc. to be its mainland China partner for the commercialization of the COVID-19 pill Paxlovid (nirmatrelvir + ritonavir), which won conditional approval from China’s NMPA earlier this year. The Beijing-based company’s shares (Shanghai:600056) jumped over 50% in the past week before the deal was confirmed, as people speculated that it would be the sole agent for the drug in China.