Leclaza’s ESMO data will determine FDA approval

Interview | Cho Byungchul, head of the lung cancer center at Yonsei Cancer Hospital

Cho Byung Chul, a professor at Yonsei University

"This data will be the basis for determining the approval of Leclaza combination therapy.

 

Following Tagrisso, the world is paying attention to how much lung cancer patients who failed to treat platinum-based anticancer drugs will react.

 

" Janssen, a partner of Yuhan, will announce new clinical data on combination therapy with Leclaza at the ESMO 2021 online academic event, which will open on the 16th (local time).

 

It is the very combination that excited the society (ESMO 2020) a year ago with an incredible number of "OR 100%." In the meantime, Leclaza's combined drug, Rybrevant, was approved by the U.S.

 

Food and Drug Administration (FDA) for the treatment of non-small cell lung cancer accompanied by 20 insertion variations of epithelial cell growth factor (EGFR).

 

What synergy effect will Leclaza and Ambantamab have this year?

 

Cho Byung-chul, a professor of oncology at Yonsei University, emphasizes, "We should pay attention to the response rate (ORR) of Leclaza and Rybrevant combination therapy unveiled at ESMO 2021." According to the abstract list released by the society, the new data for Leclaza combination therapy this year is a clinical study of CHRYSALIS-2 (phase 1b).

 

The phase CHRYSALIS-21b clinical cohort A study evaluates the OR of Leclaza and Librevant combination therapy in patients with EGFR targeted anticancer drug Tagrisso and EGFR mutant non-small cell lung cancer who do not respond to platinum-based anticancer drugs.It is a thoroughly designed study to obtain permission for Leclaza and Librevant combination therapy in patients with Tagrisso resistance.

 

According to Professor Cho, Taxotere is the only drug that can be used for patients under the current conditions.

 

Taxotere is a cytotoxic anticancer drug that causes severe adverse reactions.

 

Nevertheless, the reaction rate is close to zero (0%).

 

In other words, they try because there are no other options, but it is virtually the same as there is no cure.

 

It is predicted that early market sales will be possible through Breakthrough Therapy Design and acceleration approval.

 

Considering the case of Librevant, which obtained the FDA acceleration review in May, it is judged that the possibility is sufficient.

 

Recently, the American Society of Clinical Oncology (ASCO 2021), a combination therapy with Leclaza, also reproduced 36% OR in patients with resistance after Tagrisso treatment.

 

Professor Cho said, "Lung cancer specialists who face patients in desperate situations in the clinic every day need a new treatment.

 

This is why the world is paying attention to the ESMO announcement data, he explained.

 

We are looking forward to the release of a treatment that can be used instead of 'Taxotere' as soon as possible, he said.

 

Professor Cho is in charge of CHRYSALIS-1 multinational clinical trials, led by Janssen, evaluating Rybrevant alone and combined therapy.

 

An intermediary study on the anti-tumor mechanism of Rybrevant in Exxon 20 mutant lung cancer was conducted to reveal the mechanism of anti-tumor effectiveness.

 

Recently, it is evaluated as the leading player in leading the final FDA approval while leading the clinical development of Rybrevant.

 

Rybrevant has not yet been approved in Korea, but it is conducting a program for patients with EGFR Exon 20 mutant lung cancer.