HomeBlogFDA Approves Bavencio as a Treatment for Cancer
FDA Approves Bavencio as a Treatment for Cancer
April 22, 2022
The PD-L1 inhibitor Bavencio (avelumab) has been given accelerated approval by the Food and Drug Administration to treat patients with locally progressed or metastatic urothelial carcinoma who develop illness during, after, or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
The approval was based on results from the single-arm, open-label JAVELIN Solid Tumor trial’s urothelial carcinoma cohorts. The overall response rate was 13.3% among 226 patients followed for at least 13 weeks, and 16.1% among 161 patients followed for at least 6 months.
After more than 6 months, there were 26 responses, with 9 (5.6%) being fully completed and 17 (10.6%) being partially completed (PRs). The 30 replies in the group with a follow-up of more than 13 weeks included 9 CRs(4%) and 21 PRs (9.3%).
In neither arm had the median response time been reached yet. Both groups took an average of 2 months to answer.
In both groups, 84% of patients had detectable PD-L1 expression. PD-L1 tumor expression levels did not affect response rates in this group of patients.
The 242 patients with locally advanced or metastatic urothelial carcinoma had progressed on or after platinum-containing chemotherapy within 12 months of treatment with a platinum-containing neoadjuvant, or adjuvant chemotherapy regimen included in the JAVELIN Solid Tumor Trial.
There were 72% men and 80% white patients in the 13-week follow-up group, with a median age of 68 years. In addition, 34% and 66% of patients had ECOG performance scores of zero and one, respectively.
Alone 4% of patients had progressed after receiving prior platinum-containing neoadjuvant or adjuvant therapy only. Cisplatin and carboplatin-based regimens were previously used by 20% of patients; cisplatin alone was used by 47% of patients, and carboplatin was used by 32% of patients. At their initial evaluation, 34% of patients had liver metastases.
Bavencio was administered intravenously at 10 mg/kg every 2 weeks to patients in the JAVELIN study until progression or unacceptable toxicity occurred. Antihistamines and acetaminophen were given to each patient before receiving a Bavencio injection.
Fever (41%), infusion reaction (30%), musculoskeletal discomfort (25%), nausea (24%), decreased appetite (21%), and a urinary tract infection were the most prevalent AEs across all grades (21%).
Hyponatremia (16%), fatigue (7%), anemia (6%) hypertension (5%) urinary tract infection (5%) and musculoskeletal discomfort (5%) were the most common grade 3/4 adverse events (3%).
More than 40% of patients experienced all-grade significant adverse events (AEs), including urinary tract infection/urosepsis, abdominal discomfort, musculoskeletal pain, creatinine increased/renal failure, dehydration, hemorrhaging in the urinary system, intestinal obstruction, and fever.
In 29% and 12% of patients, Bavencio was temporarily or permanently discontinued due to AEs. Pneumonitis, respiratory failure, sepsis/urosepsis, a cerebral vascular accident, or gastrointestinal AEs were all causes of mortality in 6% of patients (14 patients).
For this indication, Bavencio’s fast approval is subject to the findings of a confirmatory study.
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