A majority of patients with advanced
EGFR/HER2-mutant non-small cell lung cancer (NSCLC) benefited from treatment with the tyrosine kinase inhibitor (TKI) poziotinib, according to a preliminary clinical trial.
An efficacy cohort of 79 patients who received investigational poziotinib 16 mg as initial therapy had an objective response rate (ORR) of 28% and disease control rate (DCR) of 86%. Overall, 72 of 79 (91%) patients had tumor reduction averaging 25.5%. Initial data from an ongoing dosing evaluation involving previously treated and untreated patients showed objective responses in seven of 30 patients and stable disease in 11 treated with 16 mg, resulting in a DCR of 60%.
Tolerability remains a challenge, as a majority of patients in the dosing study required treatment interruptions and dose reductions, and about a third of patients treated with 16 mg had grade ≥3 adverse events, reported Adrian Sacher, MD, of Princess Margaret Cancer Center in Toronto, during the European S
2 indication approved for Toripalimab in China
SHANGHAI, China, Feb. 22, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. This is the first approval of immune checkpoint blockade therapy in NPC in the world and the second approved indication for toripalimab in China. In December 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of unresectable or metastatic melanoma.
2 indication approved for Toripalimab in China
SHANGHAI, China, Feb. 22, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. This is the first approval of immune checkpoint blockade therapy in NPC in the world and the second approved indication for toripalimab in China. In December 2018, Toripalimab obtained a conditional approval from the NMPA for the second-line treatment of unresectable or metastatic melanoma.
Junshi Biosciences: NMPA Approves Toripalimab in Patients with Recurrent or Metastatic Nasopharyngeal Carcinoma after Failure of at Least Two Lines of Prior Systemic Therapy finanznachrichten.de - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from finanznachrichten.de Daily Mail and Mail on Sunday newspapers.
(2) the 3rd sNDA for Toripalimab in China
SHANGHAI, China, Feb. 19, 2021 (GLOBE NEWSWIRE) Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for Toripalimab combined with chemotherapy for the first-line treatment of patients with recurrent or metastatic nasopharyngeal carcinoma.
The supplemental NDA is based on the JUPITER-02 study (NCT03581786), which is a randomized, double-blind, placebo-controlled Phase III study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. The results of the study showed that Toripalimab combined with gemcitabine/cisplatin as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma significantly prolonged the progression-free survi