Roche (RHHBY) is up 6% after its Genentech subsidiary reported two separate pieces of positive clinical data this morning.
The company announced that the Phase III IMpower150 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of TECENTRIQ and Avastin plus chemotherapy provided a statistically significant and clinically meaningful reduction in the risk of disease worsening or death (PFS) compared to Avastin plus chemotherapy in the first-line treatment of people with advanced non-squamous non-small cell lung cancer (NSCLC). Initial observations for the co-primary endpoint of overall survival (OS) are encouraging. These data are not fully mature and the next OS analysis is expected in the first half of 2018. Safety for the TECENTRIQ and Avastin plus chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at the European Society for Medical Oncology (ESMO) Immuno Oncology Congress in Geneva, Switzerland next month.
The initial results are better than expected, and create a headache for Merck (MRK -2%) shareholders, who was in pole position in the massive lung cancer market. Roche is now in a good position for the European market, where Merck recently stumbled. AstraZeneca (AZN -0.3%) squandered its checkpoint inhibitor combo opportunity in lung cancer earlier this year. Bristol-Myers (BMY -2%) is now also farther behind in the lucrative lung cancer market.
Genentech also announced positive results from the Phase III HAVEN 3 study evaluating HEMLIBRA in adults and adolescents with hemophilia A without inhibitors to factor VIII. The study met its primary endpoint, showing a statistically significant and clinically meaningful reduction in the number of treated bleeds over time in people receiving HEMLIBRA prophylaxis every week compared to those receiving no prophylaxis. The study also met key secondary endpoints, including a statistically significant and clinically meaningful reduction in the number of treated bleeds over time with HEMLIBRA prophylaxis dosed every two weeks compared to no prophylaxis. Importantly, once-weekly HEMLIBRA prophylaxis was superior to factor VIII prophylaxis, as demonstrated by a statistically significant and clinically meaningful reduction in treated bleeds in an intra-patient comparison of patients receiving HEMLIBRA prophylaxis compared to their prior factor VIII prophylaxis.
This positive news for Roche is weighing on hemophilia players Bioverativ (BIVV -8%) and Shire (SHPG -4%).