With eight FDA-approved indications since 2013, Johnson & Johnson and AbbVie’s Imbruvica hasn’t run into many stumbling blocks. But it has hit one in non-Hodgkin lymphoma.
On Wednesday, the drugmakers said adding Imbruvica to the standard-of-care chemo regimen didn’t improve event-free survival in previously untreated diffuse large B-cell lymphoma patients. For now, the companies are staying tight-lipped on details of the flop, which will be presented at an upcoming medical meeting and published in a medical journal.
As AbbVie and J&J were quick to note, though, “clinically meaningful improvements were observed in a patient sub-population that warrant further analysis.” They also pointed out that the study targeted patients with a subtype of DLBCL that typically sees “poorer treatment outcomes”—and DLBCL, the most common type of NHL in adults, is itself already an aggressive form.
“The nature of research is such that some studies succeed and others do not. We continue to believe that ibrutinib has great untapped potential as a cancer treatment alone or in combination,” Thorsten Graef, M.D., Ph.D., head of clinical development at AbbVie’s Pharmacyclics, said in a statement.
Since winning its first-ever FDA go-ahead, Imbruvica has gone on to grab nods across six different diseases—five of them in B-cell blood cancers, including high-cost chronic lymphocytic leukemia. Imbruvica “has continued to expand its position as the clear market share leader across all lines of therapy in CLL,” AbbVie CEO Richard Gonzalez said on the company’s first-quarter earnings call in April, and that leadership helped the drug rake in $762 million for the period.
With new competition on the scene, though, AbbVie and J&J are working to branch out. Last Halloween, AstraZeneca’s Calquence hit the scene in previously treated mantle cell lymphoma, with plans to eventually threaten Imbruvica’s share in CLL as well.