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Randi Hernandez was science editor at BioPharm International from September 2014 to May 2017.
Although competing therapies will continue to be released in the immune-oncology space, efficacy profiles, combination regimens, and administration setting may influence a drug’s preferred status more than price.
Opdivo (nivolumab) and Keytruda (pembrolizumab), which were named by Forbes’ Matthew Herper as two of the most important drugs of 2014, are now being pitted as rivals in the PD-1 space. Although Merck’s Keytruda was approved three months before Bristol-Myers Squibb’s (BMS') Opdivo, BMS' product received Breakthrough Therapy, Priority Review, and Orphan Product designations from FDA, launching it into the marketplace more quickly than projected.
The focal point of competition lies in Opdivo’s response rate for melanoma, which was shown in clinical trials to be better than that of Keytruda’s; BMS said in a press release its drug offers a substantial improvement over all six of the other available therapies to treat unresectable or metastatic melanoma.
Some analysts and sources closely watching these two therapies predict that both Keytruda and Opdivo-which cost $150,000 per patient per year-may jumpstart a pricing war similar to what was recently seen with Gilead’s Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir). Because oncology treatments are extremely personalized, however, a pharmacy benefits manager such as Express Scripts may not be as quick to cut a deal with a drug manufacturer to selectively offer one of these cancer treatments over the other.
A key factor that may differentiate the success of each drug is the approval timeframes for additional indications. Early data presented at the 56th American Society of Hematology (ASH) Annual Meeting showed response rates of 66% with Keytruda in patients with relapsed or refractory Hodgkin's lymphoma, whereas 87% of patients exhibited a response to Opdivo in a separate study treating the same condition.
In addition to Hodgkin’s lymphoma, BMS is testing Opdivo for the treatment of non-small cell lung cancer, renal cell carcinoma, and solid tumors. BMS will also evaluate the combination of Opdivo and monoclonal antibody FPA008 as a potential treatment option for patients with six different tumor types-non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer, and malignant glioma.
Merck received Breakthrough Therapy designation for Keytruda for the treatment of non-small cell lung cancer in October 2014. Keytruda was also said to show "encouraging anti-tumor activity" in a trial for PD-L1-positive, advanced triple-negative breast cancer, one of the most aggressive forms of the disease. In that breast cancer study, which was presented at the 2014 San Antonio Breast Cancer Symposium, 33% of patients treated with Keytruda achieved tumor shrinkage.
Although access to Opdivo and Keytruda will be closely monitored, Leerink analyst Seamus Fernandez told Medical Marketing & Media that Opdivo's main selling point over Keytruda “may rest with a physician and managed-care support infrastructure for Yervoy (ipilimumab), as BMS estimates that, of 3500 melanoma infusion centers, 80% infuse the drug.” Currently, patients with melanoma must try BMS’ Yervoy as a first-line treatment method before trying either Opdivo or Keytruda.
Opdivo may also gain the upper hand if it can achieve first-line treatment status. BMS and Ono Pharmaceutical are investigating the activity of the combination regimen of checkpoint inhibitors Opdivo and Yervoy in treatment-naïve patients in the ongoing trial dubbed CheckMate-067. In CheckMate-067, the one-year overall survival rate for patients with advanced melanoma was 94% and the two-year overall survival rate was 88%.
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