The next pharma Blockbusters...Merck, BMS, AstraZeneca, Roche.

  
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In September, Merck's PD-1 blocker Keytruda (pembrolizumab) received accelerated approval from the FDA to treat melanoma and the company is researching the drug against non-small cell lung cancer (NSCLC) and other indications. In its World Preview 2014 Outlook report, EvaluatePharma forecasts Keytruda sales of $4.06 billion by 2020.

That's a great start, but it's unclear whether Merck's advantage will hold out over the long haul. The competition will be fierce in the PD-1/PD-L1 space. With the huge potential market, this could be the equivalent of the Oklahoma land rush for the usual pharma titans. However, Stephanie Hawthorne, senior director at Kantar Health, notes that, for now in melanoma, Merck is in the driver's seat compared to BMS's PD-1 inhibitor Opdivo (nivolumab), which is a few months (or possibly longer) behind Keytruda in the US. 

"It's a big advantage for Merck being first-to-market," says Hawthorne. "Based on the available data, they both look really efficacious, and they're fairly well tolerated compared to Yervoy. BMS's saving grace might be the combination of Opdivo and Yervoy they are studying. The survival data we've seen for it so far is really impressive, and that could trump Merck's lead." 

Hawthorne's point was underscored in late September when BMS released data at the European Society for Medical Oncology (ESMO) showing that Opdivo achieved a 32% response rate against advanced melanoma in patients who had previously been treated with Yervoy. The control group, which received traditional chemo, had an 11 % response. 

While Keytruda was first in the US, Opdivo was approved for melanoma in Japan in July, under a deal with BMS partner Ono Pharmaceuticals. The ESMO data will only support BMS's showing in the US. The FDA has given Opdivo fast track designation in NSCLC, melanoma, and renal cell carcinoma (RCC) and breakthrough therapy designation for Hodgkin's lymphoma. In September, BMS announced that both the FDA and European Medicines Agency (EMA) have accepted Opdivo for accelerated review for melanoma. The FDA PDUFA date is March 30, 2015. 

"Opdivo is the most valuable pipeline drug in development at the moment," says Lisa Urquhart, editor of Evaluate's editorial team, EP Vantage. "The data from studies is showing some impressive advances in both overall survival and disease progression." 

EvaluatePharma pegs Opdivo's potential sales at $6 billion by 2020. The company believes Opdivo could be approved for melanoma in the US next year. Meanwhile, Hawthorne expects approval for the Opdivo/Yervoy combination in early 2016. 

That's in melanoma. Opdivo may even have a more clear-cut advantage in being first-to-market for NSCLC, where BMS has already submitted its drug for approval while Merck is still completing Phase III trials. 

 Genentech/Roche's PD-L1 offering, MPDL3280A (RG-7446), is in trials for NSCLC, melanoma, RCC, and bladder cancer. The company received breakthrough designation for this last indication. EvaluatePharma puts sales at $2.93 billion by 2020, while the Thomson Reuters Cortellis database puts them at $1.2 billion by 2019. 

MedImmune/AstraZeneca is also in the race with PD-L1 drug MEDI-4736, primarily targeting NSCLC. Also shared at ESMO, a small 18-person study showed a 28% response to MEDI-4736 combined with the CTLA-4-directed antibody tremelimumab. Cortellis projects MEDI-4736 sales at close to $1.1 billion by 2019. 

"We're just at the tip of the iceberg for immuno-oncology, but the enthusiasm is certainly warranted because of the kinds of responses and the tumors being opened up," says Fernandez. "The field is about as exciting and confusing as you could possibly imagine." (Más)