AbbVie and its development partners have big plans for the upcoming American Society of Hematology (ASH) meeting that starts Dec. 3. They’re presenting 25 studies of three cancer drugs: Imbruvica (ibrutinib), Venclexta (ventoclax) and Empliciti (elotuzumab). For AbbVie, the event will be one step in an ongoing effort to beef up its oncology pipeline as it braces for the loss of its $14-billion-a-year drug to treat autoimmune diseases, Humira (adalimumab).
Gary Gordon, vice president of oncology development for AbbVie, says the company is excited about all three drugs but has particularly high hopes for Venclexta, which it develops in partnership with Roche. The FDA approved the drug in April to treat patients with chronic lymphocytic leukemia (CLL) who have a mutation called 17p deletion. At ASH, researchers will present data in CLL, acute myeloid leukemia (AML), as well as three studies of the drug in multiple myeloma.
After Venclexta’s initial approval, analysts estimated the drug could bring in about $2 billion a year. But AbbVie and Roche continue to look for market expansion opportunities, not just by testing the drug in other blood cancers, but also by looking at potential combination treatments. During ASH, researchers will present a safety analysis from a trial of the drug in combination with Roche’s Rituxan (rituximab) in patients with relapsed CLL. “We’re waiting for that study to read out,” Gordon told FiercePharma in an interview. “We hope sometime in the next year to have very exciting data.”
Gordon says the company is also encouraged by early signals of Venclexta’s effectiveness in multiple myeloma. ASH will feature data on Venclexta both as a monotherapy and in combination with Velcade (bortezomib) and steroids. “I think we’re beginning to understand some of the markers that might predict who in the setting of multiple myeloma is likely to have good responses to Venclexta,” Gordon says.
AbbVie and Roche are also presenting several studies of Venclexta in AML. The companies boast FDA “breakthrough” designation for newly diagnosed AML patients who can’t tolerate chemotherapy—a population that’s in desperate need of more treatment options, Gordon says. “We’re pretty excited about that program. AML is an area that hasn’t matured very much in terms of therapeutic options in the last couple of decades,” he says. “It’s nice to see it’s a nut that’s beginning to crack in terms of medicines that are bringing new tools to the table.”
Several studies of Imbruvica (ibrutinib), which AbbVie is developing with Johnson & Johnson, will be presented at ASH, including results from a trial in patients with marginal zone lymphoma, a form of the disease for which there are no FDA-approved therapies. Empliciti (elotuzumab), marketed in conjunction with Bristol-Myers Squibb, will be featured in two poster presentations, one of which will analyze the budget impact of the treatment in multiple myeloma. That’s appropriate considering that the drug, approved a year ago in combination with Celgene's Revlimid (lenalidomide) and dexamethasone, has drawn criticism for its estimated annual cost of $142,000.
At ASH, AbbVie will have plenty of competition from other biopharma companies hoping to draw attention to their emerging treatments for blood cancers. Analysts at BioPharm Insight expect that Novartis, Juno and Kite will grab the spotlight with long-anticipated late-stage data on their chimeric antigen receptor T-cell (CAR-T) treatments. Recent patient deaths linked to Juno’s experimental product will raise the scrutiny among analysts, BioPharm Insight predicts, but there is still plenty of enthusiasm for its two rivals. ASH will include fresh data on one of Novartis’ CAR-T treatments in pediatric patients, and another in adults with multiple myeloma.
Kite, which could complete its first FDA filing for a CAR-T treatment by the end of the year, will present data at the conference in non-Hodgkin lymphoma. Kite recently added a drug to its treatment protocol to prevent seizures, Biopharm Insight notes, which “could be effective to curb neurotoxicity rates, experts say,” it wrote in a pre-ASH report, “yet an incomplete understanding of seizures generates uncertainty.”
As for AbbVie, ASH could be a prime venue to boost the profile of its oncology pipeline and take a bit of attention away from the loss of Humira. Over the summer, the FDA approved a biosimilar version of Humira made by Amgen, prompting AbbVie to sue for patent infringement. AbbVie has been aggressively defending its patents on the drug, predicting it will hold off biosimilar competition until 2022. But analysts are far less optimistic: Citi’s Andrew Baum has predicted sales of the drug will hit $16 billion next year and then start to decline, falling to $6 billion in 2022.