- Roche's anti-PDL1 immunotherapy atezolizumab on Wednesday won an early FDA approval for treatment of the most common form of bladder cancer, marking the first new drug to be approved for that type of cancer in decades.
- Atezolizumab, now branded as Tecentriq, is the first approved PD-L1 inhibitor in the U.S. and joins two closely related anti-PD1 drugs already on the market—Bristol-Myers Squibb's Opdivo and Merck's Keytruda.
- With this approval, Roche jumps ahead of AstraZeneca, which has been developing its own anti-PDL1 immunotherapy for bladder cancer. Strong launches from Opdivo and Keytruda, coupled with promising clinical results, have driven strong interest in the drug class from drugmakers as well as markets.
All three drugs—Opdivo, Keytruda, and now Tecentriq—are so-called checkpoint inhibitors, which work by blocking certain proteins expressed on tumor cells that naturally check the body's immune response to cancer. By hindering these interactions, checkpoint inhibitors can boost the ability of immune cells to target and kill the tumor cells.
Checkpoint inhibitors, and particularly the anti-PD1/PDL1 drugs, have demonstrated promising efficacy in clinical trials and at times induced dramatic responses to cancer. In a particularly high-profile case, former President Jimmy Carter went into remission after receiving treatment with Keytruda following chemotherapy.
However, the drugs haven't been effective in all patients, prompting drugmakers to test dozens of combination treatments in an attempt to broaden response rates across patients.
Tecentriq was approved for second-line treatment of patients with advanced or metastatic urothelial cancer—a type of bladder cancer which accounts for 90% of all cases. In a phase 2 study, treatment with Tecentriq shrank tumors in 14.8% of patients, a surrogate endpoint measuring the drug's effect against the cancer. The FDA approved Tecentriq on an accelerated approval basis, meaning Roche will have to complete further study to verify the drug's efficacy.
Among the 100 patients with a higher level of PD-L1 expression in tumor-infiltrating immune cells, treatment with Tecentriq led to a 26% response rate and induced a complete response in 12 patients.
However, the drug also led to urinary tract infections, anemia, fatigue, and other side effects among some patients. Three people experienced severe adverse reactions which eventually led to death.
Roche is testing Tecentriq in a wide-array of cancers, including lung and breast cancer. The FDA in April granted the drug drug priority review status for second-line treatment of non-small cell lung cancer (NSCLC), with a target action date of October 19.
A second approval would not only boost Tecentriq but also put it into direct competition with Opdivo and Keytruda, both of which are approved to treat NSCLC. Roche is hoping for a strong launch to help offset slowing growth in older cancer drugs like Avastin, Herceptin, and Rituxan. By winning approval in bladder cancer first, Tecentriq may be better able to build up market share as Opdivo and Keytruda aren't yet approved in this indication.
Tecentriq will reportedly cost around $12,500 per patient per month, a price point similar to its competitors, according to the New York Times.
All three drugs are expected to quickly reach blockbuster status and are projected for multi-billion-dollar sales by 2020. But drugmakers must still prove their treatments can work across a broader range of patients, and confirm the drugs actually extend patient life.