Despite the prolonged Covid-19 pandemic, the American Society of Clinical Oncology (ASCO) remains one of the most noteworthy oncology conferences in the world. It provides companies with an opportunity to gauge the clinical success of pipelines for pharmaceuticals and allows physicians to gain insight into the latest cancer treatment trends. This is the first in a series of articles Korea Biomedical Review publishes to present the key clinical outcomes and development strategies of Korean companies participating in ASCO. -- Ed.

 

Hanmi Pharmaceutical said Monday that foreign companies commercializing its cancer drug candidates have presented their study results at the American Society of Clinical Oncology (ASCO) conference this year.

Hanmi's three partners – Spectrum Pharmaceuticals, Genentech, and Athenex – disclosed their study results of poziotinib, combo therapy of belvarafenib and cobimetinib Ordadoxel (ingredient: docetaxel and encequidar) for treating various rare cancers.

Hanmi Pharmaceutical has released a computer tomography (CT) image of how belvarafenib induced 68 percent response at the 56th week of the study's baseline.
Hanmi Pharmaceutical has released a computer tomography (CT) image of how belvarafenib induced 68 percent response at the 56th week of the study's baseline.

Spectrum Pharmaceuticals, Hanmi's U.S. partner that licensed in the technology of poziotinib in 2015, showed how the drug candidate affects central nervous system (CNS) activity in non-small cell lung cancer patients with epidermal growth factor receptor (EGFR) or human epidermal growth factor receptor 2 (HER2) Exon 20 mutation.

The study results were based on the data from cohorts 1, 2, and 3 of the ongoing clinical trial ZENITH20. The company assessed the results of 36 patients with brain metastases at baseline among 284 patients.

Spectrum said that three of the 34 patients, or 8 percent, have achieved complete responses. 

Brain metastasis occurs in up to 25 percent of NSCLC patients and is associated with short survival. The patients in the study received 16 milligrams of poziotinib once every day.

"CNS metastasis is a common and life-threatening complication in NSCLC patients," said Dr. Francois Lebel, chief medical officer at Spectrum Pharmaceuticals. "Our study results have shown a clinically significant effect of poziotinib in patients with brain metastases with EGFR or HER2 Exon 20 mutations," he said.

Genentech unveiled the study results of belvarafenib plus cobimetinib in treating patients with advanced solid tumors through oral presentation.

Hanmi licensed out belvarafenib to the Roche subsidiary in 2015, and the two companies confirmed tolerance and safety with a new dose in the study ongoing in Korea.

Belvarafenib is a potent and selective type-2 RAF dimer inhibitor, which shows efficacy in treating patients with solid tumors caused by RAS or RAF mutation.

Yonsei Cancer Hospital Professor Shin Sang-joon, who led the HM-RAFI-103 study of belvarafenib, introduced the interim results.

In the NRAS-mutant melanoma study for expanding indication, five out of 13 patients had a partial response (PR), with the best overall response rate (ORR) of 38.5 percent. Eleven among the 13 patients had been treated with a checkpoint inhibitor, and 45.5 of them achieved a partial response. The median progression-free survival period was 7.3 months.

"We have confirmed excellent anticancer effect and safety of belvarafenib in the combo therapy study," Professor Shin said. "We saw an encouraging efficacy, especially in melanoma patients with NRAS mutations."

Genentech is also conducting additional global studies of the drug for melanoma patients with NRAS mutations.

Athenex, a biopharmaceutical company dedicated to developing novel cancer therapy, presented its phase 1 study results of Oradoxel. The company applied its Orascovery platform to turn docetaxel into an oral formulation.

The company also posted two sub-analysis of phase 3 studies that assessed the anticancer effect of oral paclitaxel plus encequidar across tumor subgroups.

It conducted a phase 1 study to investigate the bioavailability, safety, and tolerance of Oradoxel compared to intravenous (IV) therapy.

Athenex did not see dose-limiting toxicities or severe side effects from patients who took Oradoxel. Also, the mean absolute bioavailability was 15.9 percent, with pharmacokinetics (PK) exposure reaching non-linear at 300 milligrams per square meter.

In addition to the phase 1 study results, the company released an updated data of phase 3 trial of oral paclitaxel in metastatic breast cancer patients, demonstrating a superior response rate of an oral formulation of paclitaxel compared to intravenous injection.

In the study of 402 patients with metastatic breast cancer, oral paclitaxel showed 35.8 percent ORR in the intent-to-treat population, while IV formulation only resulted in 23.4 percent ORR.

"We are pleased to see our partners release the study results of our novel drugs at the annual meeting of the world's largest cancer society," Hanmi Pharmaceutical CEO Kwon Se-chang said.

The global academic community has also paid attention to the new drug candidates developed by Korea and the U.S., such as the recently published study results of belvarafenib in Nature, Kwon added.

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