After two years and several failed tests, Merck KGaA, Darmstadt, Germany and GlaxoSmithKline have ended a nearly $ 4 billion development deal focused on the investigational immunotherapy drug bintrafusp alfa.
The termination of the agreement was announced on Thursday, months after bintrafusp alfa failed to meet target in a Phase II clinical trial as a potential second-line treatment for metastatic bile duct cancer (CTB). This trial failure in patients who have failed or are intolerant of first-line platinum-based chemotherapy follows a decision made by the two companies. stop development of bintrafusp alfa as first-line treatment for patients with stage IV non-small cell lung cancer (NSCLC) and high expression of PD-L1.
The asset was in Phase III of development when the companies disconnected following a recommendation from the Independent Data and Security Oversight Board. In this trial, bintrafusp alfa was combined with Keytruda, a checkpoint inhibitor developed by the US company Merck. The Board of Directors recommended that the trial be discontinued after a review determined that the study was unlikely to meet its primary endpoint of progression-free survival.
Bintrafusp alfa is an experimental bifunctional fusion protein immunotherapy. Merck KGaA and GSK initially joined forces to develop the active in 2019. The objective was to target the experimental treatment on multiple cancer indications considered difficult to treat.
When companies signed the development collaboration for bintrafusp alfa, GSK made an upfront payment of 300 million euros (approximately $ 445 million) to Merck KGaA. Additional milestone payments of up to € 2.9 billion ($ 3.4 billion) should have been made. However, because bintrafusp alfa did not meet milestone targets, Merck KGaA stated that no additional payments have been made to the company and that no future obligations remain related to this agreement.
The decision to end the partnership is a particularly heavy blow for GSK and struggling CEO Emma Walmsley as the company splits into two entities, a more agile pharmaceutical company and a mainstream healthcare company.
With her extensive experience in consumer health products, which includes leading GSK’s own consumer health division as well as a 17-year stint at L’Oréal, Walmsley has been criticized by several GSK stakeholders for its leadership in the pharmaceutical business. The main charge against her is that she does not have the scientific knowledge to run a pharmaceutical company.
Although Walmsley was under fire from activist investor groups Bluebell Capital Partners and Elliott Management, the company’s board of directors supported his decision to keep Walmsley as CEO. The company split is scheduled for mid-2022. Last summer, Walmsley described the proposed split of the two activities of GSK. As BioSpace previously reported, the pharmacy-focused company dubbed New GSK is forecasting revenue of around $ 46 billion by 2031.
Following the merger, New GSK will continue to focus on the four main therapeutic areas of HIV, Infectious Diseases, Immunology / Respiratory and Oncology. The company’s vaccines business is expected to be a key driver, alongside its specialty drugs business. GSK has 20 different vaccine candidates in its pipeline, as well as its adjuvant pandemic technology.
New GSK also has 42 specialty drugs in development. By examining the two pipelines, the company predicted that many of these assets offer top-notch potential opportunities.
For Merck KGaA, which developed bintrafusp alfa, the company said the failed trials deepen its understanding of TGF-β and will help guide its future development of therapies targeting this pathway.