Roche’s new immunotherapy oncology medicine atezolizumab has passed a mid-stage trial helping bladder cancer patients reduce the size of their tumours.
The Swiss cancer specialist published data from the IMvigor 210 study, which showed its investigational cancer immunotherapy atezolizumab shrank tumours (known as the objective response rate) in people with locally advanced or metastatic urothelial bladder cancer as a second-line treatment. Full data of by just how much ORR was achieved has not however been released.
There are currently few drug options for treating bladder cancer outside of chemotherapy, although a number of drugs from Novartis, Merck & Co and Allergan are also looking to grow this market.
Sandra Horning, chief medical officer and head of global product development at Roche, said: “We are encouraged by the number of people who responded to atezolizumab and maintained their response during the study because minimal progress has been made in advanced bladder cancer for nearly 30 years.
“We plan to present results at an upcoming medical meeting and will discuss next steps with health authorities to bring a new treatment option to patients as soon as possible.”
Last year, the FDA granted a ‘Breakthrough Therapy Designation’ for atezolizumab in people whose metastatic bladder cancer expressed PD-L1.
This designation is designed to speed up the development and review of medicines intended to treat serious diseases with few medical resources.
Roche is, however, playing catch-up in the PD-1 and PD-L1 market race, as rivals Bristol-Myers Squibb and Merck & Co have already gained approval for their PD-1 medicines Opdivo (nivolumab) and Keytruda (pembrolizumab), which both received the FDA nod for melanoma last year.
Roche is also battling with AstraZeneca to be the third to market in this new therapy area – although its PD-L1 drug works slightly differently to the approved PD-1 medicines on the market.
The Swiss major is betting that its mechanism of action will help separate it from the PD-1 field, and also lead to better cure rates in the long term. Merck & Co is however also testing Keytruda in certain bladder cancer patients who exhibit PD-L1 biomarkers, meaning Roche could have an immediate competitor should both drugs gain approval.
The PD-1 and PD-L1 market is set to be wroth around $30bn by the end of the decade, although BMS is expected to take around a $6bn share of this as Opdivo is set to gain further cancer licences in the coming years.
Atezolizumab is also being studied in a phase I trial in combination with Amgen’s cancer immunotherapy alimogene laherparepvec in patients with triple-negative breast cancer and colorectal cancer with liver metastases.
Roche has also posted survival data among patients with non-small cell lung cancer who express high levels of PD-L1, as well as starting new trials into assessing its efficacy in certain kidney cancer patients.