Johnson & Johnson drops sirukumab after FDA blow, cans phase 3 AML trial

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While the sirukumab decision was telegraphed, the discontinuation of the phase 3 trial of talacotuzumab came out of left field.

Five months ago, Johnson & Johnson painted sirukumab and talacotuzumab as part of a wave of blockbusters-in-waiting that would drive growth for years to come. Today, J&J abandoned plans to win approval of its once-hyped rheumatoid arthritis drug sirukumab and stopped a phase 3 trial of talacotuzumab in acute myeloid leukemia (AML).

The likelihood of J&J washing its hands of sirukumab jumped late last month when the FDA sided with its advisory committee and rejected the anti-IL-6 monoclonal antibody. Back then, J&J said it would look into what it would take to address the FDA’s concerns about the number of people who died after taking sirukumab in clinical trials.

With the FDA asking for additional clinical data and sirukumab already trailing other, seemingly safer, IL-6 drugs from Roche and the Regeneron-Sanofi alliance, J&J has opted to cut its losses despite maintaining its belief the antibody. 

"We have made the difficult decision to withdraw the applications we had filed globally for sirukumab in rheumatoid arthritis," a spokesperson for J&J said. "The need for additional clinical data would result in significant delays to patient access in parts of the world. Given this, as well as the availability of other treatments targeting the IL-6 pathway, Janssen has made a strategic decision to prioritize other assets in our portfolio."

While that decision was telegraphed from the moment the FDA advisory committee voted 12 to 1 against J&J’s filing, the discontinuation of the phase 3 trial of talacotuzumab came out of left field.

Xencor, which provided the antibody technology behind talacotuzumab, learned in March that J&J had moved the drug into the phase 3 portion of its phase 2/3 AML trial. Seven months later, J&J has discontinued the trial. J&J provided no explanation for the abrupt u-turn in its brief statement disclosing the setback. The Big Pharma made no mention of trials in indications other than AML. 

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Other CD123 drugs have encountered safety problems—a fact J&J knows all too well. The FDA put J&J’s CD3-CD123 bispecific antibody JNJ-63709178 on clinical hold 13 months ago after learning of serious adverse events. 

CD123 is also the target of the Cellectis’ CAR-T that was hit with a clinical hold last month following the death of one of the first two patients to receive the therapy. And it is the target of Stemline Therapeutics’ SL-401, which was linked to patient deaths in a trial that is forging ahead following the implementation of steps to mitigate the safety concerns. 

Whatever J&J learned in the first seven months of the phase 3 was enough to persuade it to scrap the trial, a decision it is unlikely to have taken lightly. With sirukumab falling by the wayside, J&J needs other drugs to step up and deliver the growth it committed to in a bullish presentation earlier this year.

That event saw J&J executives hail their pipeline as “one of the most robust and sustainable ... in the industry” and talk up how it could redefine “the cyclical nature of our industry.” With two of J&J’s 11 anointed drugs having fallen already, the robustness of the Big Pharma’s pipeline faces a test.