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Genentech Announces Positive Interim Results From Phase III HAVEN 4 Study


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(RTTNews.com) - Genentech, a member of the Roche Group ( RHHBY ), announced positive interim results from the Phase III HAVEN 4 study evaluating HEMLIBRA (emicizumab-kxwh) prophylaxis dosed once every four weeks in adults and adolescents (12 years of age or older) with hemophilia A with and without inhibitors to factor VIII.

At this interim analysis after a median of 17 weeks of treatment, HEMLIBRA prophylaxis showed a clinically meaningful control of bleeding. These results are consistent with previous studies of HEMLIBRA dosed once weekly or every two weeks, including the pivotal studies in hemophilia A with inhibitors, HAVEN 1 in adults and adolescents and HAVEN 2 in children, as well as the Phase III HAVEN 3 study in adults and adolescents with hemophilia A without inhibitors.

The most common adverse events with HEMLIBRA were injection site reactions, with no new safety signals observed. No thrombotic microangiopathy or thrombotic events occurred in this study.

The study showed that people who received TECENTRIQ and Avastin plus chemotherapy had a 38 percent reduced risk of their disease worsening or death (progression-free survival, PFS) compared with those who received Avastin plus chemotherapy (hazard ratio [HR]=0.62, p<0.0001, 95 percent CI: 0.52-0.74; median PFS = 8.3 vs. 6.8 months). Importantly, a doubling of the 12-month landmark PFS rate was observed with the combination of TECENTRIQ and Avastin plus chemotherapy (37 percent) compared to Avastin plus chemotherapy (18 percent).

The rate of tumor shrinkage (overall response rate, ORR), a secondary endpoint in the study, was higher in people treated with TECENTRIQ and Avastin plus chemotherapy compared with Avastin plus chemotherapy (64 percent vs. 48 percent). The safety profile of the TECENTRIQ and Avastin plus chemotherapy combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified with the combination.

The analysis of the co-primary PFS endpoint in IMpower150 was assessed in two populations: all randomized people without an ALK or EGFR genetic mutation (intention-to-treat wild-type, ITT-WT) and in a subgroup of people who had a specific biomarker (T-effector "Teff" gene signature expression, Teff-WT). IMpower150 met its PFS co-primary endpoint per study protocol for both populations assessed.

In the Teff-WT population, the combination of TECENTRIQ and Avastin plus chemotherapy reduced the risk of disease worsening or death by 49 percent compared to Avastin plus chemotherapy (HR=0.51, p<0.0001, 95% CI: 0.38-0.68; median PFS = 11.3 vs. 6.8 months).

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