Celltrion said it has released the phase 3 clinical trial results of CT-P16, a biosimilar for Avastin (ingredient: bevacizumab), at the American Association for Cancer Research 2022 (AACR).

AACR is an international cancer association with over 40,000 members from 120 countries. This year, the meeting continued through Wednesday in New Orleans, Louisiana, the U.S. It will be the first in-person meeting since the Covid-19 pandemic, and it will have online sessions, too.

The company released its latest study results to healthcare professionals and pharmaceutical companies worldwide by participating in the AACR meeting.

The study unveiled during the AACR divided 689 patients with non-small cell lung cancer, one of the representative indications for Avastin, into two groups. Afterward, the participant received CT-P16 or Avastin as a combination therapy with another anticancer drug once every three weeks for the first six intervals and as a monotherapy for three years.

This was the first time that the company unveiled the trial results. Therefore, the presentation mainly addressed the results of efficacy evaluation during the induction trial, which was the primary endpoint.

CT-P16 demonstrated equivalence in efficacy with the original drug by satisfying the equivalence margin in comparing the original drugs' objective response rate during the induction test period after administration.

Based on the global phase 3 clinical trials results, Celltrion has completed an application for CT-P16 product approval in Korea, the U.S., and the EU for a full label approval for all of Avastin's indications.

After completing the approval process in each country, Celltrion will introduce the product to the global market sequentially.

"As CT-P16 proved similar in safety to the original drug in phase 3 large-scale global clinical trials, we plan to speed up the approval process through consultation with regulatory authorities in each country," a company official said. "We will do our best to ensure the prompt supply of high-quality anticancer antibody biosimilars when we obtain approval from each country."

Roche's Avastin, the original drug for CT-P16, is an anticancer drug used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer, and glioblastoma and had a global sale of about 4 trillion won ($3.2 billion) last year.

If Celltrion releases CT-P16, it will mark the third anticancer antibody biosimilar in its product line, following the existing blood cancer treatment Truxima and breast cancer treatment Herzuma.