Another immunotherapy has been approved for use in urothelial cancer, the most common type of bladder cancer, in the United States.
Avelumab (Bavencio, EMD Serono INc), which is a programmed cell death ligand–1 (PD L1) inhibitor, has been approved for second-line use in patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The new drug joins three similar immunotherapies already approved for similar indications, and experts have said that immunotherapy is already "altering the landscape" for the treatment of bladder cancer.
Atezolizumab (Tecentriq, Genetech Inc), also a PD-L1 inhibitor, was the first immunotherapy to be approved for second-line use in urothelial cancer. It was approved in May 2016. More recently, it was approved for first-line use.
Durvalumab (Imfinzi, AstraZeneca) was approved just last week for second-line use in urothelial cancer, along with a complementary diagnostic test for assessing the PD-L1 levels in tumor tissue.
Nivolumab (Opdivo, Bristol-Myers Squibb), a PD inhibitor, was approved for second-line use in February 2017.
And waiting in the wings is another PD inhibitor, pembrolizumab (Keytruda, Merck & Co), which has been tested in clinical trials for this indication.
Avelumab was granted an accelerated approval by the US Food and Drug Administration (FDA) on the basis of data from a single-arm, open-label study that enrolled 242 patients. The agency gave the following details of efficacy and safety in a press release.
The patients had locally advanced or metastatic urothelial carcinoma and had experienced disease progression while receiving or after having received platinum-based therapy or within 12 months of receiving a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.
All patients received avelumab, 10 mg/kg intravenously, every 2 weeks until radiographic or clinical progression or unacceptable toxicity. All patients received premedication with an antihistamine and acetaminophen prior to each avelumab administration.
The results show that the confirmed overall response rate (ORR) in 30 patients who had been followed for at least 13 weeks was 13.3% (95% confidence interval [CI], 9.1 - 18.4). The ORR was 16.1% (95% CI, 10.8 - 22.8) in 26 patients who had been followed for at least 6 months.
The median time to response was 2.0 months (range, 1.3 - 11.0). The median duration of response had not been reached in patients who had been followed for at least 13 weeks or at least 6 months but ranged from 1.4+ to 17.4+ months in both groups.
Deaths due to an adverse reaction occurred in 6% of patients, the FDA noted. Serious adverse reactions were reported in 41% of patients. The most frequent serious adverse reactions reported in 2% or more of patients were urinary tract infection/urosepsis, abdominal pain, musculoskeletal pain, creatinine increased/renal failure, dehydration, hematuria/urinary tract hemorrhage, intestinal obstruction/small intestinal obstruction, and pyrexia. The most common adverse reactions that occurred in at least 20% of patients were fatigue, infusion-related reaction, musculoskeletal pain, nausea, decreased appetite, and urinary tract infection.
The recommended dose of avelumab is 10 mg/kg as an intravenous infusion over 60 minutes every 2 weeks. Premedication with an antihistamine and acetaminophen prior to the first four infusions of avelumab is recommended.
Full prescribing information is available online.
Cite this: Avelumab: Another Immunotherapy for Bladder Cancer - Medscape - May 09, 2017.