EHA: AbbVie, Roche cement Venclexta's place in AML with survival win

AbbVie and Roche’s Venclexta has struggled to significantly prolong acute myeloid leukemia (AML) patients’ lives when coupled with a certain type of chemo. But not azacitidine.

Adding Venclexta to azacitidine slashed the risk of death by 34% among previously untreated patients, the partners said Saturday at the European Hematology Association’s virtual annual congress.

Patients taking the Venclexta combo lived a median 14.7 months, versus just 9.6 months for the azacitidine-only group. Venclexta also upped the percentage of patients who achieved complete remission to 66.4% from the 28.3% azacitidine posted on its own.

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The combination has “clear potential to change how we are treating the patients and what benefits we can bring to them in the future,” Mohamed Zaki, M.D., Ph.D., vice president and global head of hematology development at AbbVie, said.

Patients who fail on azacitidine wind up in hospice with no other options, and quickly; “When you don’t treat these people, they might live about three months,” he said, adding, “we’re talking about a death sentence.” About 20% to 30% of patients might have even less time left, “so we’re dealing with a ticking bomb—a patient where we’re just running around trying to help them in any way we can,” Zaki said.

With that in mind, “having that combination is, for me," an achievement "of a lifetime—when I can help someone stay alive way longer than would have been otherwise,” he said. And lengthening lives is key, as it can help “bridge” patients to new therapies that aren’t yet available, he pointed out.

Because of AML’s aggressive nature, the time to response is important, too, and the Venclexta regimen works quickly, Zaki noted. Within a month—and sometimes less—trial patients’ quality of life transformed in some cases, he said, adding that “I’ve been doing this for many years, and it’s not every day we see something like this.”

The “quickness” with which the Venclexta-azacitidine combo “brings the disease down is unmatched,” Zaki said.

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The trial win is key for AbbVie and Roche, as it backs up a conditional AML approval the FDA doled out in late 2018 based on response rates. The agency okayed Venclexta in tandem with either azacitidine, decitabine or low-dose cytarabine (LDAC) but in late February, the Venclexta-LDAC pairing failed to significantly extend patients’ lives over LDAC alone in a confirmatory phase 3 trial.