Two of Roche's new generation of drugs—including the just-approved hemophilia therapy Hemlibra—racked up new data Monday that bolster their case for blockbuster sales.
In the long-awaited Haven 3 study in a broad group of hemophilia A patients, Hemlibra delivered "clinically meaningful" reductions in the number of treated bleeds, when used as a prophylactic treatment, Roche said Monday morning. Those reductions were seen in patients using Hemlibra as a preventive, compard with those who weren't using preventive treatment at all.
But as analysts pointed out, the drug beat a rival type of treatment—Factor VIII replacements—at preventing those bleeds, according to an intrapatient comparision. The drug was approved Thursday for hemophilia A patients who have grown resistant to Factor VIII therapy.
Meanwhile, Roche's checkpoint inhibitor Tecentriq hit its study goal in previously untreated lung cancer patients. As an add-on to chemo and its older therapy Avastin, Tecentriq beat chemo and Avastin alone at preventing the cancer's advance, the company said. As for prolonging patients' lives, the data are "encouraging," Roche said.
Details of both studies aren't yet public, and the lung cancer study hasn't yet fully wrapped up, but the results stand to expand use of both drugs. The Haven 3 study puts Hemlibra in line for a broader hemophilia A approval, and the lung cancer study, dubbed IMpower 150, makes Tecentriq "a real competitor" in first-line non-small cell lung cancer, as Evercore ISI analyst Umer Raffat put it.
Not to mention its implications for immuno-oncology treatment overall, with Merck & Co. and its chemo-combo approach on one side and Bristol-Myers Squibb and AstraZeneca's CTLA4 combos on the other. Lung cancer is the most hotly contested area in immuno-oncology because of its size, and previously untreated patients make up the largest share of that market.
Tecentriq's success here means a bigger threat for its rivals, particularly Merck, given its chemo-combo approval. The PD-1/L1 market "is largely a zero-sum game," Bernstein analyst Tim Anderson said in an investor note. "Roche's good fortune means there is less to go around for other companies."
In hemophilia, Evercore analyst Steven Breazzano now figures Roche's drug could steal share from Factor VIII treatments. "[G]iven the superiority language, which combined with a profile featuring once or twice a week subcutaneous administration and competitive pricing in the broader hemophilia A population, suggests Hemlibra will become a big drug at the expense of Factor replacement," Breazzano wrote Monday.
Roche wasn't shy about making the same suggestion, either. "Hemlibra is the first product to show superior efficacy to factor VIII prophylaxis," CMO Sandra Horning said in Monday's statement, adding, "We look forward to working with health authorities to make this treatment available for all people with hemophilia A as soon as possible.”