One answer to Keytruda’s patent cliff (and it’s not Seagen)

Merck & Co’s Keytruda juggernaut rolls on – today posting second-quarter sales of $5.3bn, up 30% – but how long will the good times last? This is now the biggest question for Merck as it faces US patent expiry, perhaps in 2028, on one of pharma’s most successful drug franchises ever. One plan is to develop a subcutaneous version of Keytruda. Most advanced here is a phase 3 front-line NSCLC trial due to end early next year that Merck today said was designed to support filing. The company said it expected demand for formulations beyond IV, adding that it had more than one SC pembrolizumab programme in development. Investors will note that it is not alone: Pfizer, for one, is working on sasanlimab, a SC anti-PD-1, though as a novel project this could have a tougher regulatory path than a reformulated Keytruda. Merck was also asked about co-formulating Keytruda with an ADC – presumably a veiled reference to Seagen, an ADC specialist it is apparently thinking of buying – but said such combos could be difficult to advance clinically. There is still no news about an acquisition of Seagen, which reports its quarterly financials after market close today.

Trials of subcutaneous pembrolizumab
Study Setting Title Enrolment
Phase 3
3475-A86 1st-line NSCLC Chemo combo of pembrolizumab SC vs IV 450
Phase 1
Keynote-555 1st-line Braf w/t melanoma Bioavailability study of pembrolizumab SC vs IV 136
3475A-C18 Advanced solid tumours Bioavailability study of MK-3475A (SC pembrolizumab + recombinany human hyaluronidase MK-5180) 72

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