- A cancer drug from Roche and AbbVie, when combined with a commonly used chemotherapy, kept previously untreated patients with acute myeloid leukemia alive and in remission longer than chemo alone, the Swiss drugmaker said Monday.
- Patients in the Phase 3 trial, called VIALE-A, didn't qualify for intensive chemotherapy treatment initially because of age or other medical conditions. The study should strengthen the case for use of Roche and AbbVie's drug, Venclexta, in frontline disease, where it currently has only conditional approval.
- Last month, however, the companies revealed Venclexta failed in the VIALE-C trial, which tested the drug in a similar setting but paired it with another chemotherapy called cytarabine.
Winning accelerated approval isn't usually the end of the story for drugs granted the designation by the Food and Drug Administration. In AML, Roche and AbbVie secured Venclexta's approval in 2018 on the basis of an 80-patient trial with no comparison to placebo treatment. The companies, therefore, needed to run more trials to confirm its benefit.
The only targeted agent approved for first-line AML treatment, Venclexta was tested in combination with azacitadine against azacitadine alone in 431 patients who didn't qualify for intensive induction chemotherapy, similar to its authorized use. The companies hoped to show that patients on the combination lived longer and were more likely to go into remission.
Roche's Monday statement said VIALE-A achieved those goals, but did not disclose any specific data. Patients with AML have a five-year survival rate of less than 5% — similar to advanced lung cancer — and 38,000 new patients are diagnosed each year in the United States and Europe, according to the company.
Last month, the VIALE-C trial showed the cytarabine combination reduced the risk of death by 25%, a result that missed statistical significance. That finding raised questions similar trials could fail and push the FDA to pull its AML approval. The companies' announcement Monday, however, should ease those worries.
Venclexta is a fast-growing product for the two companies, with AbbVie reporting revenue from its share of the collaboration more than doubled to $792 million in 2019. Another key Phase 3 readout is due soon, testing the drug in multiple myeloma in combination with Pomalyst and dexamethasone in relapsed disease.