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Enfortumab vedotin-efjv plus has received NMPA approval for patients with locally advanced or metastatic urothelial cancer.
China’s National Medical Products Administration (NMPA) has approved enfortumab vedotin-efjv (Padcev)in combination with pembrolizumab (Keytruda) for the treatment of adult patients with locally advanced or metastatic urothelial cancer.1
In December 2023, the combination received FDA approvalfor the same patient population.2 Both regulatory decisions were supported by results from the phase 3 EV-302/KEYNOTE-A39 trial(NCT04223856), findings from which were presented at the 2023 ESMO Congress and published in the New England Journal of Medicine.1
Data from EV-302 demonstrated that enfortumab vedotin plus pembrolizumab (n = 442) generated statistically significant and clinically meaningful improvements median overall survival (OS) and median progression-free survival (PFS) compared with platinum-containing chemotherapy (n = 444).1,3 At a median follow-up of 17.2 months, the median OS with the combination was 31.5 months (95% CI, 25.4-not reached) vs 16.1 months (95% CI, 13.9-18.3) with chemotherapy (HR, 0.47; 95% CI, 0.38-0.58; P < .001).
Furthermore, the combination reduced the risk of disease progression or death by 55% (HR, 0.45; 95% CI, 0.38-0.54; P < .001), producing a median PFS of 12.5 months (95% CI, 10.4-16.6) vs 6.3 months (95% CI, 6.2-6.5) with chemotherapy. The agent’s safety profile was consistent with prior reports, and no new safety issues with the combination were identified.
"The NMPA approval of enfortumab vedotin in combination with pembrolizumab is the first non-platinum treatment for Chinese patients with advanced urothelial cancer that can be used in the first-line setting,” professor Guo Jun, lead primary investigator of the EV-302 trial in China, stated in a news release.1 “The results of the EV-302 study demonstrate that this combination nearly doubled median OS, and increased median PFS, overall response rate [ORR] and complete response rate compared to platinum-based chemotherapy. These results were seen in a broad population of patients with locally advanced or metastatic urothelial cancer, regardless of patients' biomarker status, cisplatin eligibility or liver metastasis. I believe that this new treatment regimen will change the clinical treatment landscape of urothelial carcinoma in China and bring hope of longer survival to more Chinese patients with advanced urothelial carcinoma."
Jun also serves as director of the Department of Urologic Oncology and Melanoma/Sarcoma, at Beijing Cancer Hospital as well as vice chairman and chief-secretary of the Chinese Society of Clinical Oncology.
In the news release, professor Huang Jian, lead primary investigator of the EV-302 study in China added that, "The current first-line treatment strategy for advanced urothelial carcinoma in China is platinum-based chemotherapy, with very limited clinical options available. The approval of enfortumab vedotin in combination with pembrolizumab represents the first treatment regimen in the past 20-30 years that has shown superiority over platinum-based chemotherapy in the entire population. We hope that this combination could become the future standard of care treatment."
Jian is also chairman of the Urology Subcommittee of the Chinese Medical Association and serves in the Department of Urology at Sun Yat-sen Memorial Hospital, Sun Yat-sen University, in Guangzhou, China.
EV-302/KEYNOTE-A39 was an open-label study that enrolled 886 patients with radiologically documented, histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma who were eligible for platinum-based chemotherapy, enfortumab vedotin, and pembrolizumab.3 Patients with various histologic subtypes were included. Key eligibility criteria included PD-1/PD-L1 inhibitor–naive status, a glomerular filtration rate ≥ 30 mL/min, and an ECOG performance status of 0 to 2.
Upon enrollment, patients were randomly assigned 1:1 to receive intravenous (IV) enfortumab vedotin at a dose of 1.25 mg/kg of body weight with a maximum of 125 mg per dose on days 1 and 8, plus 200 mg of IV pembrolizumab on day 1 of each 3-week cycle; or standard chemotherapy with gemcitabine and cisplatin or carboplatin for up to 6 cycles. In the experimental arm, pembrolizumab was administered for up to 35 cycles, with no limit on enfortumab vedotin cycles. Treatment was continued until disease progression, unacceptable toxicity, initiation of a subsequent anticancer therapy, or completion of the maximum number of treatment cycles.
The study’s co-primary end points were OS and PFS, both assessed by blinded independent central review (BICR). Secondary end points included BICR- and investigator-assessed ORR per RECIST 1.1 criteria and safety.
The most common grade 3 or higher treatment-related adverse effects observed with the combination include maculopapular rash, hyperglycemia, neutropenia, peripheral sensory neuropathy, diarrhea, and anemia.
"We are delighted that the NMPA has recognized the benefits that enfortumab vedotin has offered to patients with previously treated locally advanced or metastatic urothelial cancer in China following its approval in August 2024,” Ahsan Arozullah, MD, MPH, senior vice president and head of Oncology Development at Astellas, concluded in the news releae.1 “This latest approval in combination with pembrolizumab marks another step forward in our mission to bring new, innovative treatment strategies to patients in China. We look forward to making a significant impact on patients' lives, helping to slow disease progression and give them precious more time."
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