The Ministry of Food and Drug Safety (MFDS) Friday gave regulatory approvals to four multinational pharmaceutical companies – Bayer, Roche, Eli Lilly and Company, and AstraZeneca – to carry out clinical trials for their immunotherapies on Korean patients in the country.
Bayer Korea to start clinical trial on urogenital cancer patients
Bayer Korea got approval to carry out a phase 2/3 trial for rogaratinib (BAY1163877) on 12 Korean patients with a type of urogenital cancer.
The drug trial will aim to improve the overall survival of patients with Fibroblast Growth Factor Receptor (FGFR)-positive urogenital-cancer who had previously received platinum-containing chemotherapy.
Bayer said that it would conduct the phase 2/3 trials globally in 17 countries, including Korea, Austria, Canada, Finland, France, Hong Kong, and Israel. The Korean studies will be carried out at Samsung Medical Center, Asan Foundation, Severance Hospital, and the National Cancer Center, according to the ministry.
The launching of the randomized, open-label, multicenter phase 2/3 study to study the drug’s efficacy compared to chemotherapy follows the completion of phase 1 trials for solid tumors in Japan as second-line therapy.
Roche Korea to start Tecentriq study for head and neck cancer
Also on Friday, Roche Korea got the go-ahead to conduct a phase 3 trial for Tecentriq (ingredient: atezolizumab) as an adjuvant therapy on domestic patients with head and neck cancer.
Roche will test the PD-LI inhibitor in a randomized, double-blind, multi-center, phase 3 trial on 17 domestic patients with high-risk locally advanced head and neck squamous cell carcinoma who have previously had definitive topic therapy.
The company currently has 17 ongoing or planned phase 3 studies for the drug across several cancers, it said. Roche is also carrying out post-marketing surveillance of Tecentriq in MFDS-approved indications of non-small cell lung cancer and bladder cancer.
Tecentriq is a monoclonal antibody that binds with the programmed death-ligand 1 (PD-L1) protein. Genentech and Roche carried out clinical trials for several types of solid tumors since 2015 and eventually gained the U.S. Food and Drug Administration’s conditional approval to use the drug to treat advanced urothelial carcinoma and authorization for non-small cell lung cancer in 2016. But in May of last year, the company surprisingly failed a phase 3 trial that tested the drug as the second-line therapy for bladder cancer.
The Korean studies for head and neck cancer patients will take place at Samsung Medical Center, Seoul National University Hospital, and Asan Foundation’s Asan Medical Center, according to the ministry.
Lilly Korea to test investigational ovarian cancer drug
Lilly Korea got approval to carry out a phase 2 study for prexasertib (LY2606368) on ovarian cancer patients whose tumors resisted or were nonresponsive to platinum chemotherapy.
The test on the investigational checkpoint kinase 1 (CHK1) and CHK2 inhibitor to be held at Samsung Medical Center, SNUH, Asan Foundation, and Severance Hospital will be carried out on 18 women with the disease.
Globally, prexasertib is being investigated in clinical trials in patients with head and neck cancer, small cell lung cancer and in phase 1 trials, according to Eli Lilly and Company’s oncology pipeline.
AstraZeneca Korea to start phase 1 CLOVER trial for Imfinzi
AstraZeneca Korea also got cleared to carry out a phase 1 CLOVER trial to test the safety and efficacy of Imfinzi (ingredient: durvalumab) on advanced solid tumor cancer patients as a combination therapy with chemoradiotherapy.
The company gained approval to test the drug on 10 head and neck squamous cell cancer patients, 30 non-small cell lung cancer patients, and 58 small cell lung cancer patients at Samsung Medical Center, SNUH, and Severance Hospital, according to the ministry.
Astra’s Imfinzi is indicated to treat patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum chemotherapy.
The U.S. FDA in October last year agreed to give priority review to Astra’s request to market the drug for specific non-small cell lung cancer patients based on positive data from a Phase 3 PACIFIC trial.
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