After a 2022 failure, Merck’s mega-blockbuster has rallied in head and neck cancer. The company dropped data from a successful Phase III trial as a perioperative treatment for patients with late stage, resected, locally advanced head and neck squamous cell carcinoma.
In the KEYNOTE-689 trial, Keytruda was used as a neoadjuvant then continued after surgery in combination with radiotherapy. Compared to radiotherapy alone, the Keytruda regimen offered clinically meaningful improvement in event-free survival (EFS) for patients as well as major pathological response. Overall survival (OS) showed a trend toward improvement but without statistical significance in PD-L1 patients. OS data will be evaluated in the next interim analysis and submitted to regulatory authorities, Merck said in its announcement. If approved, it would add another notch to Keytruda’s indications belt. As of June, Keytruda has 40 FDA-approved indications and is projected to bring in more than $27 billion in sales this year.
“These results are substantial, as KEYNOTE-689 marks the first positive trial in two decades for patients with resected, locally advanced head and neck squamous cell carcinoma,” Marjorie Green, SVP and head of oncology at Merck, said in a statement.
Keytruda had previously failed to show EFS benefit as a combo treatment with chemoradiation for locally advanced head and neck squamous cell carcinoma. Results from KEYNORE-412 were presented in 2022, with the caveat of a “favorable trend toward improvement” was seen.
Meanwhile, Merck has been doubling down on I&I investments in October. A collaboration with Cambridge biotech Mestag Therapeutics announced Tuesday carries a potential value of $1.9 billion for novel therapeutic targets for inflammatory disease.
Mestag specializes in harnessing fibroblast immunology, a connective tissue cell that plays an important role in driving the immune system’s response in inflammatory disease and cancers. The biotech’s in-house programs include a bispecific antibody for solid tumors in pre-IND and assets in discovery that it says could be beneficial for rheumatoid arthritis, lupus, Sjogren’s syndrome and more.
This week’s deal allows Merck the option to license one or more targets, up to a prespecified number, from Mestag and then to take over discovery, development and commercialization. Mestag will receive an undisclosed upfront payment with the future potential fees and downstream payments totaling $1.9 billion.
The Mestag collab is Merck’s second deal in just over a week, having announced the completion of its $750 million acquisition of a clinic-ready bispecific antibody from Curon Biopharmaceutical. CN201 actively depletes B cells, offering therapeutic applications in both B cell malignancies and autoimmune diseases. The asset is in early-stage clinical trials for non-Hodgkin’s lymphoma and B cell acute lymphocytic leukemia.
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