Merck & Co’s Keytruda topped $3.1bn in sales in the third-quarter – almost a quarter of group revenues – but management insists there is more to the company than the cancer blockbuster.
Predictably, discussion of Keytruda’s massive clinical trials programme dominated Merck’s third-quarter results call. However chief financial officer Rob Davis (pictured left) stressed that 
“while Keytruda is truly a foundational product, we are a lot more than just Keytruda”.
He said the performance of other cancer drugs like Lenvima (lenvatinib) and Lynparza (olaparib), revenue from which doubled in the quarter – as well as the vaccine portfolio headed by cervical cancer vaccine Gardasil and HIV franchise – is evidence there is “a lot internally…to be excited about”.
There’s no denying that Keytruda is the story of the moment however, with its 62% sales increase helping Merck post a 15% rise in group revenues to $12.39bn and shrug off a 12% decline for diabetes treatment Januvia (sitagliptin) on pricing pressure.
Keytruda is approved for a long list of cancer types, but its sales growth has been driven largely by its dominance of the non-small cell lung cancer (NSCLC) market, and particularly the first-line therapy segment where it has broad use as a monotherapy and with chemo across squamous and non-squamous cancer types as well as low- and high PD-1 expressors.
Merck says eight out of every ten eligible first-line NSCLC patients in the US are receiving Keytruda at the moment. But with rival immunotherapies from Bristol-Myers Squibb and AstraZeneca now angling for a slice of that market, multiple analysts asked how resilient Keytruda might be to competition from newer regimens, particularly those that include CTLA4 inhibitors.
BMS has just reported data with its immuno-oncology combination of Opdivo (nivolumab) and CTLA4 drug Yervoy (ipilimumab) in the CheckMate-9LA trial, and also has positive results from the CheckMate-227 study on this regimen in first-line NSCLC with high tumour mutation burden (TMB).
Meanwhile, AZ has just reported positive top-line results with Imfinzi (durvalumab) plus experimental CTLA4 tremelimumab in the POSEIDON study.
Merck’s head of R&D Roger Perlmutter (pictured right) said that Keytruda has set an extremely high bar for efficacy as a monotherapy and alongside chemo, and until the CTLA-4 regimen data is presented for scrutiny it is premature to “make a judgement about benefit, risk profile and how best to treat these patients”.
When challenged to by one analyst to put on his medical doctor’s hat and say when he might consider Opdivo-Yervoy over Keytruda-chemo, Perlmutter said: “it’s difficult to identify the patient population in which a combination of … Opdivo and Yervoy would be the right choice., but I think that the argument that has been made by our colleagues at Bristol-Myers is in particular they’re looking at those individuals in whom there is less PD-L1 expression”.
That said, Perlmutter pointed to the strong data with Keytruda-chemo in PD-L1-negative patients and the good safety profile of the combination, adding: “I’m just not sure where I see a special niche for the use of a combination of a CTLA-4 antibody”.
Merck is also conducting a trial of Keytruda with Yervoy – KeyNote-598 – which will provide more information on the value of targeting CTLA-4 in lung cancer, said Perlmutter.
Merck also pointed to the potential for Keytruda growth in new indications like renal cell carcinoma, adjuvant melanoma, small-cell lung cancer (SCLC) and triple-negative breast cancer (TNBC), as well as the drug’s potential as the backbone of treatment alongside other drugs in the high proportion of patients across many cancers that don’t respond to immunotherapies on their own.
Turning to its other products, Gardasil grew 26% in the quarter to $1.3bn, while chickenpox vaccine Varivax rose 19% to $623m. Alliance revenues from Eisai-partnered Lenvima and AZ-partnered Lynparza reached $109m and $123m respectively.