Merck & Co. was not at all a prominent oncology player before the advent of Keytruda. The New Jersey drugmaker wants to consolidate its supremacy now that it has the world’s best-selling cancer medication. Jannie Oosthuizen, Merck’s head of global oncology, told investors at an event at the 2022 American Society of Clinical Cancer annual meeting that Merck has the ability to gain more than 80 oncology approvals between now and 2028.
This is in addition to Merck’s oncology portfolio’s 46 currently approved indications in the United States. Keytruda has more than 30 of them, the most of any oncology drug, and Merck expects that number to rise in the coming years, according to Oosthuizen. Keytruda was the world’s best-selling cancer drug in 2021, with sales of $17.2 billion.
According to Oosthuizen, Keytruda recently passed the 1 million commercial patient mark, and its growth could surge to 2 million patients by the end of 2024.
Keytruda’s future growth will be aided by its expansion into early-stage malignancies. Keytruda has received three additional FDA clearances for use in surgery in early malignancies since last year’s ASCO, increasing its total to six. Pre-surgery and post-surgery therapy of early triple-negative breast cancer, as well as post-surgery adjuvant therapy for select kidney cancer patients and completely resected stage 2B or 2C melanoma, are among the latest signings.
Merck recently touted a success in the KEYNOTE-091 trial for Keytruda in the all-important reactive non-small cell lung cancer (NSCLC) setting for prospective near-term regulatory requirements. It also expects results from the phase 3 KEYNOTE-671 trial, which is evaluating Keytruda as a neoadjuvant and adjuvant treatment for NSCLC patients in stages 2 to 2B.
Between 2022 and 2025, Merck is conducting 14 Keytruda phase 3 trials in early-stage illnesses. According to those figures, Merck anticipates early-phase settings to account for around 25% of overall Keytruda revenue by 2025, as per Oosthuizen. Merck CEO Rob Davis estimated the early-stage fraction at 30% during the company’s fourth-quarter results call in February. Davis was referring to Keytruda’s revenue in the United States.
An FDA clearance, however, will not be enough to break into the early-stage market, according to Oosthuizen. At the commercial organisation, they are working to guarantee that the whole breadth and capabilities of the organisation are meeting the needs of its customers by successfully delivering necessary details to them when they need it and in the route they prefer, the executive added.
Oosthuizen believes this is critical in the early-stage scenario. Merck is working on an under-the-skin form of Keytruda for this purpose. He added that the company is using digital marketing to help with its commercial execution. New tumour types, early lines of therapy—including adjuvant and neoadjuvant—new mechanisms, combinations, and formulations will all be major growth drivers in Merck’s broader oncology agenda, according to Oosthuizen.
Merck is keeping an eye on some prominent immunotherapy targets, such as CTLA-4, LAG-3, and TIGIT, for possible pairings with Keytruda. Lynparza, which is paired with AstraZeneca; Lenvima, which is shared with Eisai; and Tukysa, which is partnered with Seagen- are in clinical trials with Keytruda.
In terms of new mechanisms, Merck’s Welireg was approved by the FDA last year to help patients with rare von Hippel-Lindau disease-related cancers. It’s the first HIF-2alpha inhibitor approved in the United States. Merck is also testing the medicine in diverse renal disease scenarios as a single therapy in combination with Lenvima, both with and without Keytruda.
