Merck’s Subcutaneous Keytruda Meets Expectations in Phase III

 

Analysts are split on whether the positive trial results will help Merck stem future Keytruda losses as the mega-blockbuster goes off patent in 2028.

Seeking to extend the reign of cancer king Keytruda, Merck has shown that a subcutaneous version of the anti-PD-1 therapy performs as well as the more invasive infusion formulation in a Phase III trial.

Merck paired the under-the-skin version of Keytruda and Alteogen’s berahyaluronidase alfa to support the subcutaneous delivery with chemotherapy, in patients with first-line metastatic non-small cell lung cancer (NSCLC) against intravenous Keytruda with chemotherapy in the trial called MK-3475A-D77. The trial hit is primary endpoint, showing that subcutaneous administration of Keytruda performed as well as an infusion when given every six weeks. Additional safety and efficacy endpoints were also met.

Although Merck is still facing the loss of exclusivity on Keytruda in 2028, the data could help build up a patchwork of indications and trials to stave off a full switchover to biosimilar versions of the drug, according to BMO Capital Markets analysts.

Patients and their doctors may opt for the subcutaneous version in the indications where it’s available due to the ease of administration, the firm noted.

Guggenheim analysts called the results “an important step for the longevity of the Keytruda franchise.” Merck executives have said that up to 50% of patients could someday be a candidate for the subcutaneous formula, Guggenheim said, possibly opening up access to Keytruda in areas with limited access to infusion centers.

Merck is also testing the under-the-skin version alone in a Phase III trial for patients with first line NSCLC who have a positive tumor proportion score, as well as in Phase II tests for relapsed and refractory Hodgkin’s lymphoma and primary mediastinal large B-cell lymphoma.

Guggenheim believes the FDA may ultimately grant approval for the subcutaneous version in all indications where the IV version is currently cleared, which is similar to what has happened for Roche’s Tecentriq.

“While we do not necessarily expect these studies will fully suppress expected revenue declines from Merck’s Keytruda [loss of exclusivity], they could slow the speed of such declines, allowing Merck more time to build revenue from other key assets like Winrevair, Capvaxive, etc.,” the BMO team wrote.

In a further effort to extend its cancer dominance, Merck last week signed a licensing deal with Shanghai-based LaNova Medicines to advance a next-generation cancer therapy that targets the PD-1 and VEGF pathways. This morning, Guggenheim said the deal should help ease some of the exclusivity concerns even as the available data from the PD-1/VEGF class remains premature.

https://www.biospace.com/drug-development/mercks-subcutaneous-keytruda-meets-expectations-in-phase-iii