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May 20, 2021

Janssen’s Imbruvica combination provides survival benefits in CLL trial

Janssen’s Imbruvica plus venetoclax provides survival benefits in Phase II chronic lymphocytic leukaemia trial.

The Janssen Pharmaceutical Companies has reported that Imbruvica (ibrutinib) in combination with venetoclax demonstrated overall survival benefits in a Phase II CAPTIVATE study in chronic lymphocytic leukaemia (CLL) patients.

A once-daily drug, Imbruvica is developed and commercialised by Janssen Biotech in partnership with Pharmacyclics, an AbbVie subsidiary.

The drug is designed to hinder Bruton’s tyrosine kinase (BTK) protein, which is required by certain cancer cells for their survival.

CAPTIVATE assessed previously untreated CLL/small lymphocytic lymphoma (SLL) subjects aged 70 years or below, including those at high risk.

All subjects in the fixed-duration cohort were given Imbruvica lead-in treatment for three months. Subsequently, they received the Imbruvica plus venetoclax combination treatment, which was stopped after a year irrespective of minimal residual disease status.

The new results from the fixed-duration cohort of the trial demonstrated that 95% of subjects who received Imbruvica plus venetoclax were alive and progression-free at two years.

Deep remissions were observed across all subgroups in the trial.

A complete response rate of 56% was observed in the overall population and was similar in high-risk subgroups at a median follow-up of 27.9 months.

A 96% overall response rate was noted, while overall survival was 98% in all treated subjects in the trial.

In subjects receiving the combination treatment, the two-year progression-free survival was 93% for unmutated immunoglobulin heavy chain variable participants and 97% for subjects with mutated IGHV.

The company added that long-term results from the 269-participant Phase III RESONATE-2 trial also showed progression-free and survival benefits with Imbruvica as a monotherapy in previously untreated CLL patients.

Janssen Research & Development Oncology Clinical Development and Global Medical Affairs vice-president Craig Tendler said: “The positive results from the CAPTIVATE study demonstrate the potential of Imbruvica and venetoclax, with complementary mechanisms of action, to provide deep responses with a once-daily, fixed-duration combination that can be administered in the outpatient setting for younger, fit patients.

“The results from RESONATE-2 further support the long-term benefit of Imbruvica monotherapy in front line CLL for which the breadth and maturity of data continue to grow in support of this standard-of-care treatment and its impact on progression-free and overall survival.”

Earlier this month, Janssen reported that the latest data from the Phase III VOYAGER PAD trial showed Xarelto plus aspirin lowered severe vascular events in peripheral artery disease patients.

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