Needle core biopsy with adenocarcinoma with necrosis occupying the left half of the image and an adjacent area to the right of small cell, B-cell lymphoma. Credit: Yale Rosen.

The Janssen Pharmaceutical Companies of Johnson & Johnson has reported positive results from the iLLUMINATE (PCYC-1130) trial.

iLLUMINATE is a Phase III trial designed to evaluate the combination of imbruvica (ibrutinib) plus obinutuzumab against chlorambucil plus obinutuzumab in patients with newly diagnosed chronic lymphocytic leukemia / small lymphocytic lymphoma (CLL/SLL).

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The randomised, multi-centre, open-label trial enrolled a total of 212 patients.

Results showed that the combination of imbruvica (ibrutinib) plus obinutuzumab significantly improved progression-free survival (PFS) in the patients compared to chlorambucil plus obinutuzumab.

Lead investigator Carol Moreno said: “With 2.5 years of follow-up, results from the iLLUMINATE study showed significantly prolonged progression-free survival of IMBRU imbruvica VICA plus obinutuzumab versus a commonly used chemoimmunotherapy regimen in chronic lymphocytic leukemia.

“Imbruvica plus obinutuzumab represents an important advance and a welcome potential new combination regimen for patients living with CLL.”

“Imbruvica plus obinutuzumab represents an important advance and a welcome potential new combination regimen for patients living with CLL.”

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Patients were randomised to receive once-daily dose of imbruvica 420mg continuously until disease progression or unacceptable toxicity in combination with obinutuzumab 1000mg intravenously over six cycles (n=113).

Imbruvica is a bruton’s tyrosine kinase (BTK) inhibitor jointly developed and commercialised by Janssen Biotech and Pharmacyclics.

The solution is also being studied under a Phase Ib/II trial and its extension study (PCYC-1102, PCYC-1103) with up to seven years of follow-up to treat patients with newly diagnosed and relapsed / refractory (R/R) CLL/SLL.

Results from the Phase Ib/II trial and its extension have demonstrated durable, long-term survival benefits of imbruvica as a monotherapy.

Janssen Research and Development Global Medical Affairs vice-president Craig Tendler said: “These long-term results suggest that 80% of newly diagnosed patients with chronic lymphocytic leukemia receiving Imbruvica monotherapy sustained remission through seven years without chemotherapy.

“Together with the iLLUMINATE study findings, thiss data provides compelling evidence to consider imbruvica as a single agent or combination option for appropriate newly diagnosed patients with CLL.”