Biotechnology company Exelixis has entered a clinical collaboration agreement with Roche to conduct three Phase III clinical trials of combination therapy to treat cancer.
The alliance is intended to assess Exelixis’ Cabometyx (cabozantinib) in combination with Roche’s Tecentriq (atezolizumab) in patients suffering from locally advanced or metastatic solid tumours.
Cabozantinib is a small molecule receptor tyrosine kinase inhibitor, while atezolizumab is a PD-L1 immune checkpoint inhibitor.
The three Phase III trials will enrol advanced non-small cell lung cancer (NSCLC), castration-resistant prostate cancer (CRPC) and renal cell carcinoma (RCC) patients. It will be co-funded by the partners.
The clinical collaboration is based on a favourable profile demonstrated in the ongoing Phase Ib COSMIC-021 clinical trial, which is enrolling 24 expansion cohorts for 12 tumour types, including NSCLC, CRPC and RCC.
Exelixis president and CEO Michael Morrissey said: “Encouraging Phase I data suggests this combination of cabozantinib and atezolizumab may improve outcomes for patients with prostate, lung and kidney cancers, and we look forward to collaborating with Roche to learn more in these pivotal trials.
“This clinical collaboration is an important further step in our committed efforts to maximise the value of the cabozantinib franchise through these cost-sharing clinical collaborations in additional high-impact indications, while building value with new compounds from internal and external sources in 2020 and beyond.”
Cabometyx already holds approval to treat advanced RCC and hepatocellular carcinoma patients who previously received sorafenib treatment.
In 2016, Exelixis signed an exclusive licensing agreement with Ipsen to commercialise and develop cabozantinib in other indications outside of the US and Japan.
If Ipsen chooses to help fund these Phase III or future trials, the company will have access to those study data.
In 2017, Exelixis also signed a similar agreement with Takeda for rights in Japan. This agreement will also provide Takeda with access to trial results, if the company contributes to the funding of the trials.