The US FDA granted conditional approval to Roche’s PD-L1 inhibitor atezolizumab as a treatment for bladder cancer based on phase II data.
The Swiss pharma group is the third company to enter the fast-emerging PD-1/PD-L1 inhibitor market after – after Merck & Co and Bristol-Myers Squibb – and the first to get approval for an immuno-oncology drug in bladder cancer.
Specifically, the FDA has approved atezolizumab (MPDL3280A) – which will be sold as Tecentriq – for people with locally advanced or metastatic urothelial carcinoma (mUC) whose disease has progressed during or after platinum-based chemotherapy.
The PD-L1 inhibitor can also be used in cases where the cancer has worsened within 12-months of platinum chemotherapy, before or after surgery. mUC accounts for the vast majority (around 90%) of all bladder cancers.
Tecentriq is also the first PD-L1 inhibitor to be approved for marketing, as Merck’s Keytruda (pembrolizumab) and BMS’ Opdivo (nivolumab) both target PD-1.
PD-L1 is the ligand that binds to the PD-1 receptor, and blocking either target removes a ‘molecular brake’ that stops the immune system attacking cancerous cells.
Roche’s drug has been approved based on data from the IMvigor 210 study involving 310 mUC patients, which revealed that around 15% of patients on Tecentriq responded to treatment, with the effect lasting for almost 14 months.
Among patients whose tumours tested positive for PD-L1 the effect was greater, with a response rate of 26% versus 9.5% for PD-L1-negative tumours.
Roche has said it plans to launch the drug within the next two weeks and that the drug will be priced at around $12,500 per month, just about in line with the PD-1 inhibitors.
Analysts have predicted that sales of Tecentriq will eventually top $3bn a year assuming it wins additional approvals in other indications, notably triple-negative breast cancer and PD-L1-positive non-small cell lung cancer (NSCLC).
Opdivo backed in first haematological cancer
At the moment, Keytruda and Opdivo are both approved to treat melanoma and NSCLC, while Opdivo has also been given a green light in renal cell carcinoma and – just this week – classical Hodgkin’s lymphoma (cHL). Meanwhile, Keytruda is weeks away from a possible approval in head and neck cancer.
Opdivo’s new approval in cHL is notable as it is the first for an immuno-oncology drug in haematological malignancies, showing the group can be useful outside the realm of solid tumours.
The drug’s label allows it to be used for a disease that has relapsed or progressed after autologous haematopoietic stem cell transplantation (HSCT) and post-transplantation treatment with Seattle Genetics/Takeda’s Adcetris (brentuximab vedotin).
The PD-1/PD-L1 inhibitors as a whole are expected to bring in sales of $35bn or more at peak thanks to their unprecedented efficacy across multiple tumour types. Sales of Opdivo and Keytruda last year were $942m and $566m, respectively.