New Cancer Drug from Hanmi Pharmaceutical Garners Attention at ASCO 2021


Hanmi Pharmaceutical was in the spotlight at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting held online, with its partners announcing noteworthy clinical findings on the new drug developed by Hanmi Pharmaceutical for cancer treatment.

According to Hanmi Pharmaceutical, Spectrum, Genentech, and Athenex unveiled important clinical results at ASCO 2021.

■ Spectrum notes efficacy of Poziotinib against metastatic brain tumors

Spectrum revealed its findings on Poziotinib’s effects on the central nervous system (CNS) in patients with non–small cell lung cancer (NSCLC) with a mutation in the EGFR or HER2 exon 20.

The results announced were based on ZENITH20, a global clinical trial carried out with the participation of NSCLC patients with EGFR or HER2 exon 20 insertion mutations. The results of 36 patients out of a total of 284 patients from cohorts 1, 2, and 3 were evaluated. The subjects included in the evaluation had metastatic brain tumors verified by an independent research institute from the baseline (recruitment phase), and 8% of the subjects (3 subjects) exhibited complete response (CR) to the drug.

Metastatic brain tumors are common among NSCLC patients, affecting up to 25%, and it is associated with a shorter survival period. The subjects in the study were administered 16mg of Poziotinib once a day.

Francois Lebel, Chief Medical Officer of Spectrum Pharmaceuticals, stated, “Metastasis in the CNS is a common and life-threatening complication in NSCLC patients. The data from the recent study demonstrate significant utility of Poziotinib in clinically treating patients with CNS metastasis who have EGFR or HER2 exon 20 insertion mutations.”

■ A clinical trial on Belvarafenib with melanoma patients to determine dosage and combination therapy

Genentech, another partner of Hanmi Pharmaceutical, gave an oral presentation on the findings of their study on combination therapy using Belvarafenib and cobimetinib with patients suffering from progressive solid tumors.

Belvarafenib is a new drug candidate that has been licensed out to Genentech, a subsidiary Roche, by Hanmi Pharmaceutical in 2015. The recent study was carried out to check to the stability and tolerability of Belvarafenib at the specified doses.

Belvarafenib is a potent and selective RAF dimer inhibitor that exhibits antitumor activity in solid tumors caused by RAF or RAS mutations. The findings announced at the presentation were from the HM-RAFI-103 study headed by Dr. Shin Sang-joon, Professor of Oncology at Yonsei Cancer Center.

It was a Phase 1b study in which Belvarafenib' and cobimetinib were administered in combination to solid tumor patients with BRAF or NRAS mutation. The study was conducted to check the safety, tolerability, maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) as primary endpoint, and pharmacokinetics, pharmacodynamics, and antitumor effect as secondary endpoints. In the indication-specific study carried out with melanoma patients with NRAS mutation, 5 of 13 patients exhibited a partial response (PR) and the best overall response rate (BORR) was 38.5%. Dr. Shin, who gave the presentation, said, “Through this study, we confirmed the excellent safety and anticancer effect of Belvarafenib. In particular, we were able to confirm its potential as a treatment for melanoma patients with NRAS mutations.”

■ Unveiling Oradoxel developed with the application of ORASCOVERY

Athenex announced the findings of Phase 1 clinical study carried out to examine the pharmacokinetics of Oradoxel (docetaxel + encequidar), an oral drug developed from docetaxel, an anticancer drug, by applying ORASCOVERY, a platform technology developed by Hanmi Pharmaceutical. Posters were also presented on two additional sub-analyses of the Phase 3 clinical trial data that examined the anticancer effect according to the molecular subtype of Oraxol, an oral drug developed from the intravenous anticancer drug, paclitaxel. Athenex conducted an open-label, two-way crossover pharmacokinetic study (Phase 1) to determine the bioavailability, safety, and tolerability of Oradoxel compared to intravenous therapy. There were no dose-limiting toxicities or serious adverse events resulting from the administration of Oradoxel.

Also, the average absolute bioavailability was 15.9%.

The results of Phase 3 post-mortem study of anticancer effects of Oradoxel according to molecular subtypes in metastatic breast cancer (MBC) patients, the objective response rate (ORR) of the 402 randomly assigned patients in an intention-to-treat analysis was 35.8%, which was superior to 23.4% recorded for the intravenously injected paclitaxel.

“It brings me great pleasure that our partners with whom we are collaborating on research demonstrated the efficacies of our new drugs under development at the general assembly of the world’s largest cancer society,” said Kwon Se-chang, Co-President and Co-CEO of Hanmi Pharmaceutical, who also added, “Research findings on Belvarafenib have recently been published in Nature, attending to the fact that the new drugs being developed by Hanmi are garnering global attention.”

Source: Financial News