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Hanmi Pharmaceutical Starts Phase 2 Global Clinical Trial of 3rd–gen Lung Cancer Drug
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Hanmi Pharmaceutical Starts Phase 2 Global Clinical Trial of 3rd–gen Lung Cancer Drug
  • By Lee Song-hoon
  • November 4, 2015, 01:30
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Hanmi Pharmaceutical's headquarters building in Songpa-gu, Seoul.
Hanmi Pharmaceutical's headquarters building in Songpa-gu, Seoul.

 

The Phase II global clinical test of HM61713, a novel 3rd generation EGFR tyrosine kinase inhibitor (TKI) for the treatment of EGFR mutation-positive lung cancer, has begun.

Hanmi Pharmaceutical and Boehringer Ingelheim (BI) announced on Nov. 3 that they completed the first patient registrations for the Phase II domestic clinical trial of HM61713 in patients with non-small cell lung cancer (NSCLC) with T790M mutations who have developed resistance to previous EGFR targeting agents.

Hanmi Pharmaceutical’s HM61713 technology was exported to BI for US$730 million (827.46 billion won) in July. Under the contract, BI has secured an exclusive license for global commercialization rights, except in South Korea, China and Hong Kong. BI plans to develop HM61713, aiming to receive approval in 2017.

HM61713 selectively inhibits the mutation of signal delivery substance EGFR involved in the growth of cancer cells, and is evaluated as the third-generation EGFR TKI, which overcomes resistance and side effects after administration with previous EGFR TKIs. Through the Phase II trials, diverse variables will be evaluated, including oxygen reaction rate (ORR).

Sungkyunkwan University School of Medicine Prof. Park Keun-chil, a coordinating Investigator of the global clinical trial and director of the division of Hematology Oncology at Samsung Medical Center, said, “The 3rd generation EGFR TKI will be an important alternative treatment to patients with EGFR mutation positive non-small cell lung cancer who failed previous EGFR TKIs. Through this clinical test, we expect to develop succeeding targeted therapy drugs and delay the use of chemotherapy which is burdensome to patients.”

Mehdi, chief medical officer of the anti-cancer division at BI, said, “BI is committed to develop an innovative new treatment for lung cancer patients, and the adoption of HM61713 clearly shows the determination of the company. The start of the Phase II global clinical trial will be an important milestone for various studies in the future, including the Phase III global clinical trial.”

Meanwhile, Hanmi Pharmaceutical officially presented the safety and efficacy results from the Phase I/II study of HM61713 in patients with EGFR mutation positive non-small cell lung cancer who failed previous EGFR TKIs at the 51st American Society of Clinical Oncology (ASCO) Annual Meeting taking place in May.