CHMP Recommends Imfinzi (Durvalumab) Plus Chemotherapy for First-Line Treatment of Extensive-Stage Small Cell Lung Cancer in the EU
AstraZeneca
Biopharmaceutical Manufacturer
Committee for Medicinal Products for Human Use
Committee for Medicinal Products for Human Use (CHMP)The Committee for Medicinal Products for Human Use (CHMP) is the committee within the European Medicines Agency (EMA) responsible for human medicines. The CHMP replaced the former Committee for Proprietary Medicinal Products (CPMP) in May 2004.The CHMP plays a vital role in the authorization of medicines in the European Union (EU). In the centralized procedure, the CHMP is responsible for: 1) conducting initial assessments of marketing authorization applications across the EU; assessing modifications or extensions to existing marketing authorizations (“variations”); considering recommendations from the Agency’s Pharmacovigilance Risk Assessment Committee regarding the safety of medicines on the market, and, where necessary, advising the European Commission to amend the marketing authorization of a medicinal product, or to suspend or withdraw it from the market.The CHMP also evaluates medicines authorized at the national level that are referred to the EMA, with the aim of maintaining a harmonized position throughout the EU.Furthermore, the CHMP and its working groups promote the development of medicines and pharmaceutical regulation by: providing scientific advice to companies researching and developing new medicines; developing scientific and regulatory guidelines to assist pharmaceutical companies in preparing marketing authorization applications for human medicines; and collaborating with international partners to harmonize regulatory requirements.
Compiled by Keke
On July 27 local time, AstraZeneca announced that Imfinzi (durvalumab) in combination with etoposide and either carboplatin or cisplatin for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) has received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for marketing authorization in the European Union.
It is reported that the CHMP issued a positive opinion based on the results of the Phase 3 clinical trial CASPIAN for Imfinzi. CASPIAN is a randomized, open-label, multicenter, global Phase 3 study that enrolled 805 patients with extensive-stage small cell lung cancer (ES-SCLC). The study aimed to evaluate the efficacy and safety of Imfinzi in combination with etoposide and either carboplatin or cisplatin chemotherapy, as well as Imfinzi in combination with chemotherapy and tremelimumab, compared to chemotherapy alone. In the treatment arms, patients received four cycles of combination therapy, while patients in the control arm were permitted to receive up to six cycles of chemotherapy and optional prophylactic cranial irradiation. The primary endpoint was overall survival (OS) in the two combination chemotherapy arms. In June 2019, the trial met one of its primary endpoints at the planned interim analysis, demonstrating an OS benefit for Imfinzi combined with chemotherapy. In March 2020, it was demonstrated that the arm receiving Imfinzi combined with chemotherapy and tremelimumab did not meet the primary endpoint.
The results demonstrated that first-line treatment with Imfinzi in combination with chemotherapy for patients with extensive-stage small cell lung cancer (ES-SCLC) yielded statistically and clinically significant improvements in overall survival (OS). Compared with chemotherapy alone, the risk of death was reduced by 27% (HR: 0.73; 95% CI: 0.59–0.91; p=0.0047). Furthermore, the Imfinzi plus chemotherapy group showed an improved objective response rate (68% vs. 58%) and a delayed time to deterioration of lung cancer-related symptoms.
A latest analysis showed that Imfinzi combined with chemotherapy continued to be effective after a median follow-up of more than two years (OS-HR: 0.75; 95% [CI]: 0.62-0.91; nominal p=0.0032); and the safety and tolerability were consistent with the known safety profiles of these drugs. No patients tested positive for anti-Imfinzi antibodies due to treatment.
Dr. Luis Paz-Ares, Principal Investigator of the trial and Head of the Medical Oncology Department at Hospital Universitario 12 de Octubre in Madrid, Spain, pointed out that the CASPIAN trial demonstrated that Imfinzi in combination with platinum-etoposide chemotherapy provides an important new first-line treatment option for extensive-stage small cell lung cancer (ES-SCLC), with favorable tolerability contributing to sustained survival benefits. The CHMP’s positive opinion marks the first approval of cisplatin in combination with immunotherapy, representing a significant step forward for patients in Europe.
Small Cell Lung Cancer (SCLC) is a highly aggressive and rapidly growing form of lung cancer, accounting for approximately 15% of all lung cancer cases, with only 6% of patients surviving five years post-diagnosis. Although patients typically respond initially to chemotherapy, the disease usually recurs and progresses rapidly. Approximately two-thirds of SCLC patients are diagnosed at the extensive stage, where the cancer has spread widely within the lungs or to other parts of the body, resulting in a particularly poor prognosis.
Imfinzi has been approved for the treatment of unresectable stage III non-small cell lung cancer (NSCLC) following chemotherapy and for advanced bladder cancer. Its use in combination with etoposide and either carboplatin or cisplatin as first-line therapy for extensive-stage small cell lung cancer (ES-SCLC) has also been approved in the United States and is currently under regulatory review in Japan and other countries.
Reference source: Imfinzi recommended for approval in the EU by CHMP for extensive-stage small cell lung cancer
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.