AbbVie, Roche leukemia drug successful in Phase III confirmatory study

The companies said Venclexta extended overall survival in untreated acute myeloid leukemia patients when combined with Bristol-Myers Squibb’s Vidaza. A prior Phase III confirmatory trial, combining the drug with low-dose cytarabine, failed.

A cancer drug made by Chicago-based AbbVie and Swiss drugmaker Roche was successful in a Phase III confirmatory trial in an aggressive form of leukemia less than a month after failing in another study.

AbbVie and Roche said Monday that the Phase III VIALE-A study of Venclexta (venetoclax), combined with Bristol-Myers Squibb’s Vidaza (azacitidine), had shown a statistically significant improvement in overall survival among patients with first-line acute myeloid leukemia unable to tolerate intensive chemotherapy or bone marrow transplant for the combination, compared with Vidaza alone. It also showed significant improvement on the co-primary endpoint of complete response with complete or incomplete hematological recovery, also known as the CR/CRi rate.

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A Deep-dive Into Specialty Pharma

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In late 2018, Venclexta won an accelerated approval from the Food and Drug Administration for frontline AML, in combination with Vidaza, among patients aged 75 and older. VIALE-A and another study, VIALE-C – combining the drug with low doses of the chemotherapy drug cytarabine – were required as confirmatory clinical trials by the FDA. However, VIALE-C failed to show a statistically significant improvement in overall survival, according to results announced in late February. The drug, which works by targeting a kinase known as BCL-2, is also approved for chronic lymphocytic leukemia. AbbVie and Roche’s Genentech subsidiary have a partnership to jointly commercialize the drug in the U.S., while AbbVie commercializes it outside the U.S., where it is marketed under the brand name Venclyxto.

“For the past three decades, there have been few options for patients with AML who cannot receive or tolerate intensive chemotherapy or a bone marrow transplant,” AbbVie chief medical officer Neil Gallagher said in a statement. “The positive results from VIALE-A support the clinical benefit of the venetoclax plus azacitidine combination in patients with AML who are ineligible for intensive chemotherapy and reflect our ongoing commitment to transform the standards of care for patients with hematologic malignancies.”

AbbVie said the results would be presented at a future medical meeting or published in a peer-reviewed journal. In any other year, that data would be presented potentially at the American Association for Cancer Research’s annual meeting in April or, more likely, at the American Society of Clinical Oncology’s meeting in late May and early June. However, the ongoing Covid-19 pandemic has prompted the cancellation and rescheduling of the AACR meeting for August, while research at the ASCO meeting will be presented virtually. Other meetings focused on hematology-oncology include the European Hematology Association conference in June and the American Society of Hematology’s meeting in December.

Photo: AbbVie