AstraZeneca, a global, innovation-driven biopharmaceutical company, and Eli Lilly and Company (Lilly), a global pharmaceutical company, announced an extension to their existing immuno-oncology collaboration exploring novel combination therapies for the treatment of patients with solid tumours.
Under the terms of the expanded agreement, AstraZeneca and Lilly will evaluate the safety and efficacy of a range of additional combinations across the companies’ complementary portfolios. Lilly will lead the execution of the studies, while both companies will contribute resources. Additional details of the collaboration, including tumours to be studied and financial terms, were not disclosed.
AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), will be combined with Lilly molecules that target the immune system, including TGF-beta kinase inhibitor, galunisertib; CXCR4 peptide antagonist; an anti-CSF-1R monoclonal antibody, which will be assessed additionally with AstraZeneca’s anti-CTLA-4 monoclonal antibody, tremelimumab.
The companies will also explore other combinations targeting tumour drivers and resistance mechanisms, including Lilly’s abemaciclib (CDK4 and 6 small molecule inhibitor) with Faslodex, AstraZeneca’s marketed selective oestrogen receptor down regulator (SERD); both Cyramza (ramucirumab) and necitumumab, Lilly’s anti-VEGFR and anti-EGFR monoclonal antibodies respectively, with AZD9291, AstraZeneca’s investigational third generation EGFR inhibitor.
Mondher Mahjoubi, senior vice president, global product strategy for oncology at AstraZeneca, said, “The extension of our collaboration with Lilly further supports our combination-focused oncology strategy and adds to our broad development programme across small molecules and immunotherapies.”
Richard Gaynor, MD, senior vice president, product development and medical affairs at Lilly Oncology, said, “The expansion of Lilly’s research partnership with AstraZeneca will explore the far-reaching potential of combining novel targeted therapies. Our respective pipelines afford multiple targeted options to create innovative combinations in immuno-oncology and beyond, that we hope will lead to future cancer treatment options.”
Earlier this year, Lilly and AstraZeneca announced a phase I clinical trial collaboration to evaluate the safety and preliminary efficacy of combining durvalumab and ramucirumab as a treatment for patients with advanced solid tumours.
In addition to combinations within the company’s own pipeline of immuno-oncology and small molecule investigational medicines, AstraZeneca and its biologics research and development arm, MedImmune, have a broad programme of combination clinical trials underway with a range of partners.
In the EU, ramucirumab has been granted marketing authorisation for use in adults, in combination with paclitaxel, for the treatment of advanced gastric or gastro-oesophageal junction adenocarcinoma following prior chemotherapy, and as a monotherapy in this setting for patients for whom treatment in combination with paclitaxel is not appropriate.
Ramucirumab is approved in the US for use as a single agent or in combination with paclitaxel as a treatment for people with advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma whose cancer has progressed on or after prior fluoropyrimidine- or platinum-containing chemotherapy. It is also approved in the US in combination with docetaxel as a treatment for people with metastatic non-small cell lung cancer (NSCLC) whose cancer has progressed on or after platinum-based chemotherapy. Additionally, it is approved in the US with FOLFIRI as a treatment for people with metastatic colorectal cancer (mCRC) whose cancer has progressed on or after therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine.
There are several additional studies underway or planned to investigate ramucirumab as a single agent and in combination with other anti-cancer therapies for the treatment of multiple tumour types.