Ono Pharma and Bristol-Myers Squib’s PD-1 inhibitor Opdivo will be tested alongside Kyowa Hakko’s mogamulizumab in patients with solid tumours, say the companies.
The partners say the combination of Opdivo (nivolumab) with mogamulizumab – an antibody directed against the CCR4 receptor which is over-expressed on various malignant T cells – “may lead to an enhanced anti-tumour immune response compared to either agent alone.”
Opdivo was launched in Japan in September for melanoma, its first world market, while mogamulizumab has been sold since 2012 for adult T-cell leukemia-lymphoma and had its indications extended earlier this year to include peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL).
BMS has already forged a series of alliance aimed at expanding the utility of Opdivo, announcing deals with Johnson & Johnson, Celgene and Novartis amongst others, but believes the combination of the drug with mogamulizumab is particularly intriguing.
Both drugs are in the emerging category of cancer immunotherapies. Opdivo enables the immune system to attack tumours, while mogamulizumab can suppress some of the immune cells that shield the tumour from the immune system, it said.
“Studying combination regimens of immunotherapies offers the opportunity to explore the potential of enhanced efficacy compared to current standards of care in treating cancer,” commented Hiroshi Awata, head of clinical development at Ono, which will carry out the trial with Kyowa Hakko in Japan.
In addition to its approval in melanoma, Opdivo has also been filed for approval as a treatment for non-small cell lung cancer (NSCLC) and renal cell carcinoma (RCC), and is also in clinical development for other solid tumours such as bladder cancer as well as haematological cancers including Hodgkin’s lymphoma.
The product is facing competition in the marketplace from Merck & Co’s Keytruda (pembrolizumab) – already approved for melanoma in the US – with other PD-1 inhibitors coming through development from AstraZeneca (AZ) and Pfizer/Merck KGaA.
Analysts have suggested the annual market for PD-1 inhibitors could eventually be worth tens of billions of dollars per year.
Mogamulizumab was formerly licensed to Amgen for non-oncology indications, but that agreement was terminated in April. Amgen had conducted some early-stage testing of the drug in asthma.