- The Food and Drug Administration has issued a partial hold on all clinical studies testing AbbVie and Roche's cancer drug Venclexta in multiple myeloma, following a review which found a greater proportion of patients died in the treatment arm versus the control group of a Phase 3 trial called BELLINI.
- In a statement, AbbVie said it is working with the FDA and other regulatory authorities to determine next steps for investigational clinical trials of the drug in multiple myeloma. The partial hold, which will stop new enrollment of patients, does not affect the currently approved indications for Venclexta or testing outside of multiple myeloma.
- Patients who are currently enrolled in studies and who are benefiting from treatment can continue, provided they discuss it with their physician, AbbVie said.
Such clinical holds aren't uncommon as drugmakers seek new therapeutic opportunities beyond the original targets for their approved medicines.
Immunotherapy studies, for example, have been put on hold in multiple myeloma in the past. In 2017, the FDA placed partial clinical holds on combination studies testing immunotherapies from Bristol-Myers Squibb, Roche, AstraZeneca and Merck & Co. The enrollment pauses were spurred by interim data from trials testing Merck's Keytruda (pembrolizumab) together with Revlimid (lenalidomide) or Pomalyst (pomalidomide).
The agency eventually lifted its holds in December 2017.
AbbVie and Roche's BELLINI study tests Velcade (bortezomib) and dexamethasone combined with either Venclexta (venetoclax) or placebo in patients with relapsed or refractory multiple myeloma, a cancer which affects plasma cells in the bone marrow.
According to AbbVie, the Venclexta combo met the trial's primary endpoint, extending progression free survival by more than 10 months over the pairing of just Velcade and dexamethasone. But 13 deaths on the Venclexta arm were judged to be treatment-emergent, compared to only one on the placebo arm.
Overall, 21% of the 194 patients receiving the Venclexta combination had died by time of the pre-planned analysis versus 11% of the 97 enrolled in the control group, AbbVie disclosed.
Rates of severe, Grade 3-5 toxicity were similar between the two arms. The company plans to publish data in a peer-reviewed journal and/or present at a future medical meeting.
According to ClinicalTrials.gov, there are currently 10 studies testing Venclexta in multiple myeloma that are classified as "recruiting" or "active not recruiting."
Venclexta binds and inhibits the BCL-2 protein. The agent was co-developed by AbbVie and Roche, following a 2007 agreement between Genentech, AbbVie and the Walter and Eliza Hall Institute of Medical Research.
The drug is commercialized by AbbVie outside of the U.S. and jointly by AbbVie and Genentech in the U.S.
Correction: A previous version of this article incorrectly identified the brand name for bortezomib, which is marketed as Velcade. Additionally, clinicaltrials.gov now only lists 10 studies under the classifications mentioned, not 11.