AbbVie/Roche’s Venclexta fails in confirmatory AML trial

AbbVie and Roche’s Venclexta has failed to significantly improve overall survival in an acute myeloid leukaemia (AML) trial that was supposed to confirm its efficacy.

Venclexta (venetoclax) is already FDA approved in AML in combination with low-dose cytarabine (LDAC) on the basis of early-mid stage trials, but may need confirmatory data from a later stage trial to maintain its license in this indication in the long term.

AbbVie said the VIALE-C trial compared Venclexta in combination with LDAC with LDAC and placebo, but failed to meet its endpoint of statistically significant improvement of overall survival (OS) in patients with AML ineligible for intensive chemotherapy at the time of the planned analysis.

Treatment with the venetoclax combination showed a 25% reduction in the risk of death compared to LDAC with placebo in the 211-patient trial.

The venetoclax with LDAC arm also showed a median OS of 7.2 months versus 4.1 months in the LDAC arm alone.

A post-hoc analysis after an additional six months of follow up showed an increase in median OS of 8.4 months in the venetoclax plus LDAC arm and 4.1 months in the placebo plus LDAC arm.

There was no word on what this means for Venclexta, although AbbVie’s chief medical officer Neil Gallagher had an upbeat assessment of the results.

He said: “The study results, while not statistically significant, are indicative of the clinical activity of venetoclax in combination with low-dose cytarabine.”

There were no surprises in terms of adverse events, which were similar to those seen in previous studies.

In the Venclexta arm, the most serious adverse events were febrile neutropenia.

While it would have been easier for AbbVie if the results of the trial were conclusive, other cancer drugs have failed to produce survival data in the past and remained on the market.

One example was Roche’s Tecentriq (atezolizumab), which is FDA approved in certain untreated bladder cancer patients.

This failed to produce a survival benefit in late-stage confirmatory trials in 2017, but stayed on the market after discussions with the FDA.

AbbVie will likely point towards the “clinical activity” shown in the trial and the results of the post-hoc analysis showing that the numerical trend in overall survival was maintained after the initial cut-off point.

The company’s shares were up nearly 4% following the announcement.

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