Bavencio (ingredient: avelumab), a latecomer in the Tecentriq-led immune checkpoint inhibitor market, improved overall survival in a bladder cancer trial, according to Merck and Pfizer.
The two companies recently announced that their programmed death-ligand 1 (PD-L1) inhibitor Bavencio improved overall survival as the first-line maintenance therapy for locally advanced or metastatic urothelial carcinoma (UC), compared to the control group, in the JAVELIN Bladder 100 study.
The JAVELIN Bladder 100 is a phase-3 and open-label study, testing Bavencio in 700 patients whose disease did not progress after platinum-based, first-line chemotherapy.
The researchers combined Bavencio with best supportive care (BSC) and compared the combo therapy with BSC alone, evaluating Bavencio’s efficacy and safety as first-line maintenance treatment for locally advanced or metastatic UC.
BSC refers to optimal treatments determined by medical staffs as appropriate, excluding active anticancer therapy. BSC includes antibiotic administration, nutritional support, metabolic disorder correction, symptom control, and pain management. However, the study allowed local radiotherapy of isolated lesions for alleviation.
The results showed that patients treated with Bavencio maintenance therapy showed a significant improvement in overall survival compared to the control group. The treatment group’s safety profile was consistent with the results of the previous studies on Bavencio.
Merck and Pfizer plan to disclose detailed data of the study at an academic conference and submit the results to regulatory agencies soon.
Five immune checkpoint inhibitors available in the market are Keytruda (ingredient: pembrolizumab), Opdivo (nivolumab), Tecentriq, Imfinzi (dervalumab), and Bavencio.
The U.S. Food and Drug Administration approved all the five immune checkpoint inhibitors for the treatment of locally advanced or metastatic UC.
Among the five, Tecentriq was the first to obtain conditional approval as the second-line treatment for patients who failed platinum-based chemotherapy in May 2016. The other four followed suit in the first half of 2017.
Also, Tecentriq and Keytruda won the conditional nod as the first-line treatment. Approval for the five therapies was based on their tumor response rate and duration of the response. Drug companies need to confirm the drugs’ therapeutic effect through further studies to get the full license.
The FDA granted conditional approval because there was no other alternative to platinum-based chemotherapy in the systemic treatment of bladder cancer. Bladder cancer’s five-year survival rate is only 5 percent, which makes patients desperate to get a new treatment to extend survival.
Kim In-ho, a professor at the Oncology Department of Seoul St. Mary’s Hospital, said there were no treatment options in the bladder cancer treatment other than platinum-based chemotherapy.
“If the first-line standard therapy fails, we could try the second-line treatment using paclitaxel. But the second-line therapy rarely works, and the response rate is less than 10 percent,” Kim noted.
Tecentriq, which was the first to get the nod, failed to improve overall survival in a study to confirm the efficacy as the second-line treatment. It also was unable to prove overall survival improvement in the first-line treatment, compared to the existing platinum-based chemotherapy, in the Imvigor-130 trial, announced at the European Society for Medical Oncology (ESMO) Congress in the second half of last year.
However, Bavencio became the first to prove overall survival improvement and neared winning the license with the most robust data.
Bavencio is targeting a different indication from that of Tecentriq.
Tecentriq nabbed the nod as the first-line monotherapy in patients with PD-L1 expression above 5 percent and who were unable to receive cisplatin-based chemotherapy. The agent is used as the primary treatment in patients who cannot tolerate toxic cisplatin treatment. However, Bavencio is used as a maintenance therapy to delay exacerbations in patients who have been treated with cisplatin or carboplatin.
Industry watchers are paying attention to whether Bavencio’s maintenance therapy will become the first standard therapy for locally advanced or metastatic bladder cancer, which will hinge on the hazard ratio for overall survival of patients to be unveiled soon.