AZ nails immunotherapy colours to Imbruvica's mast

AstraZeneca has sealed a deal to combine its MEDI4736 immunotherapy candidate with Janssen's fast-growing leukaemia therapy Imbruvica.

Launched earlier this year in the US, Janssen's drug is set to be a blockbuster, and securing the deal helps AstraZeneca maintain its pursuit of PD-1/PD-L1 immunotherapy leaders Merck and BMS.

Janssen and Pharmacyclics have previously agreed to test Imbruvica alongside Opdivo as a therapy for non-Hodgkin's lymphoma (NHL).

AstraZeneca's MEDI4736 will be tested in combination with Bruton's tyrosine kinase (BTK) inhibitor Imbruvica (ibrutinib) as a treatment for patients with haematological cancers including diffuse large B-cell lymphoma and follicular lymphoma. A second collaboration will see the two drugs being trialled as a combination for solid tumours.

Imbruvica - originally developed by Pharmacyclics - is already on the market for chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma (MCL) and is thought to be one of Janssen parent Johnson & Johnson's fastest-growing new drugs - although the company has not yet started breaking out sales figures for the product in its quarterly reports.

Analysts predict Imbruvica can hit peak sales of between $4 billion and $6.5 billion, provided it continues to add new indications - so MEDI476 could get a leg-up in the haematological and solid cancer marketplace if the combination generates positive data in trials.

With MEDI4736 starting Phase 3 trials in February, AZ is lagging a little in the PD-1/PD-L1 inhibitor sector, given Merck & Co's Keytruda (pembrolizumab) and Bristol Myers Squibb's Opdivo (nivolumab) already on the market for melanoma and in late-stage development for other cancer indications such as non-small cell lung cancer.

Briggs Morrison, AZ's chief medical officer, said the haematological cancers are an area of significant unmet need as many lymphoma patients still progress despite treatment.

The deal with Janssen and Pharmacyclics "is also further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer," he added.

MEDI4736 blocks the signals that help tumours avoid detection by the immune system, while ibrutinib blocks signals that tell malignant B cells to multiply and spread uncontrollably. The Phase 1 part of the haematological trial will try to establish a recommended dose regimen for the combination, while the Phase 2a phase will assess its safety and efficacy.

Pharmacyclics chief executive Bob Duggan said the combination of Imbruvica and MEDI4736 "has the potential to enhance efficacy and duration across the landscape of haematological cancers" and could "improve the treatment of solid tumours in patients who need better therapeutic options."

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