ASH: AbbVie's Venclexta trounces chemo in Rituxan CLL combo study

Venclexta
AbbVie's Venclexta currently bears an approval in CLL associated with the 17p deletion, but AbbVie and Roche are looking to take the drug to patients without that genetic mutation.

ATLANTA—AbbVie and Roche are working to widen Venclexta’s patient population in previously treated chronic lymphocytic leukemia, and some new combo data should get the job done.

In a phase 3 study, Venclexta, in tandem with Roche’s Rituxan, cut the risk of disease worsening or death by 83% compared with a bendamustine-Rituxan combo, the companies said Tuesday at the American Society of Hematology (ASH) annual meeting.

Median progression-free survival hadn’t yet been reached in the Venclexta arm, while the bendamustine arm registered median progression-free survival of 17 months. Investigators pegged 24-month progression-free survival estimates at 84.9% for the Venclexta-Rituxan duo and just 36.3% for the bendamustine-Rituxan pairing. And Venclexta prompted a larger proportion of overall responses, too.

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Venclexta’s makers are hoping to broaden the med’s reach in CLL, where it's currently approved specifically for CLL associated with a mutation called the 17p deletion. The study presented at ASH enrolled CLL patients with or without that mutation, who had either relapsed after at least one round of chemo-containing therapy or failed to respond to previous regimens.

RELATED: Armed with new data, AbbVie, Roche likely to file early for bigger Venclexta use in CLL: analyst

On the expansion front, in September AbbVie and Roche netted a breakthrough designation from regulators for the combo. “We’re pretty excited about what this means for what we can offer for patients,” Gary Gordon, AbbVie’s head of oncology development, said in an interview.

Right now, the challenge in CLL is providing “patients with an option to have defined interventions for relatively short periods of time that can provide them sustained periods of relapse-free survival without having to take any drugs.” And what AbbVie is hoping for “is that we build these combinations with Rituxan and other agents that give patients that sort of benefit,” Gordon said.

There’s another reason the partners are amped about the new data, too—and that’s what it may signal for Venclexta’s potential in previously untreated patients, the focus of two ongoing phase 3 trials.

RELATED: J&J, AbbVie's Imbruvica breaks into larger CLL market with first-line FDA nod

AbbVie, of course, already has a first-line CLL go-ahead for fellow cancer-fighter Imbruvica, which it shares with Johnson & Johnson. “I think together, these two drugs are fundamentally going to change the landscape of how we treat patients with CLL,” Gordon said, but “exactly how that’s going to play out I think we’ll learn over the next few years.”

In the meantime, the Illinois pharma is testing Venclexta outside the CLL arena, too, in diseases such as acute myeloid leukemia and multiple myeloma.

“We think we’re writing a series of books that are going to be be pretty interesting,” Gordon said, adding that “there will be additional volumes in the series that’ll come out over the next couple of years.”

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