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AbbVie, Roche see survival leaps for chronic leukemia patients with drug combo

A combination of AbbVie Inc.'s Venclexta and Roche Holding AG's Rituxan diminished signs of chronic lymphocytic leukemia in 26.8% of relapsed and refractory patients and more than doubled two-year rates of survival without the disease worsening, according to a phase 3 trial.

The Murano results, which put the combo therapy head-to-head with a Rituxan and bendamustine regimen that is common in current treatment, were presented as a late-breaking abstract at the American Society of Hematology conference in Atlanta. Bendamustine is sold commonly as Teva Pharmaceutical Industries Ltd.'s Treanda, but also generically.

The primary endpoint of Murano was progression-free survival or living without the disease worsening. On the Venclexta regimen, 84.9% of patients reached the 24-month mark progression-free, compared to 36.3% in the traditional therapy arm. All the patients in the trial had received at least one prior therapy and some had tried up to three before relapsing or not responding to treatment.

Venclexta is being jointly developed by AbbVie and Roche's Genentech group, commercialized by the partners in the U.S. and solely by AbbVie outside of the country.

Venclexta has already received a breakthrough therapy designation from the U.S. Food and Drug Administration to treat a subset of chronic lymphocytic leukemia, or CLL, patients with 17p deletion, a chromosomal mutation that results in a particularly poor prognosis with few treatment options.

The 92 patients with 17p deletion in the Murano trial responded strongly to the therapy, AbbVie's head of oncology, Gary Gordon, said in an interview on the sidelines of the conference.

"That's a group that has historically not done as well with therapy and actually they did very well in the [Venclexta/Rituxan] arm," Gordon said.

The chances of 17p deletion rise the longer a patient has the disease and undergoes treatment. Gordon estimated as much as 30% of the population has tried multiple therapies, or roughly 3,000 U.S. patients with this specific mutation.

Across measures — from achieving remission to minimally residual disease in the bone marrow — the Venclexta regimen is better than the control therapy, he said.

However, there were more serious side effects with the Venclexta regimen than the control arm, which Gordon said was expected based on what researchers already knew about Venclexta as a single agent, as well as information from an earlier phase 2 combo trial.

The major toxicity came from neutropenia, a dangerously low white blood cell count that can lead to infection; 57.7% of Venclexta patients had severe neutropenia reactions, compared to 38.8% in the control pool.

Gordon said this condition can be easily managed with different interventions on the market.

Approving Venclexta for the full relapsed and refractory CLL indication could increase its potential market by five times, Cowen analyst Steve Scala said in a Nov. 28 note.

AbbVie is now exploring other combinations with Venclexta and its utility for other blood cancers, Gordon said in the interview, adding that the company expects to file these results for broader CLL treatment within the next three months.