Leclaza's ASCO data is like a global champion

Cho Byung-chul, professor of oncology at Yonsei Cancer Hospital

36% ORR after 11 months of follow-up

Cho Byung-chul, a professor at Yonsei University

The response rate for 'Lazertinib+Amivantamab' is the same as when ESMO was announced?

 

It's ridiculous.

 

The data is incomparably more complete than it was 7 months ago.

 

" Professor Cho Byung-chul (oncology at Yonsei Cancer Hospital) commented on Leclaza (Lazertinib) combined data.

 

A number of questions have been asked since the opening of the American Society of Clinical Oncology (ASCO 2021) and some misinterpretations need to be corrected.

 

Professor Cho will introduce the latest clinical results related to combined therapy of Leclaza and Amivantamab at the ASCO 2021 online conference on the 5th of next month.

 

This is the follow-up announcement of CHRYSALIS 1b, which drew much attention at the European Oncology Society (ESMO 2020) last year.

 

The purpose is to evaluate the response rate of 'Lazertinib+Amivantamab' combined therapy in patients with resistant non-small cell lung cancer.

 

The published objective response rate (ORR) is 36%.

 

Fifteen out of 45 Tagrisso-resistant patients reached a partial reaction (PR) that reduced the tumor size by more than 30%, and one showed a complete reaction (CR) that completely disappeared.

 

Because ORR figures are the same as when ESMO 2020 was announced, it can be accepted as the same data.

 

"Even if the ORR values are the same, the maturity of clinical data has completely changed," Professor Cho added.

 

The key is the difference in follow-up periods.

 

Data released at the time of ESMO showed a follow-up period of only about four months after medication.

 

On the other hand, the tracking period of ASCO's announcement increased to 11.8 months.

 

In other words, the same response rate was maintained even though the tracking period has more than doubled.The duration of the reaction in patients who responded to the drug administration was more than 10 months.

 

When the concept of biomarker is combined, the reaction rate increases further.

 

Eight out of 17 patients with EGFR and MET mutations, known as Tagrisso's most common cause of resistance, showed treatment responses, achieving ORR 47%.

 

However, the absence of biomarkers does not mean that the response rate is low.

 

Of the remaining 28 people whose biomarkers were not identified, eight showed tumor responses to combined Lazertinib+Amivantamab administration.

 

In terms of ORR, it is 29%.

 

"There is a group of patients who are good at responding to Lazertinib+Amivantamab combined therapy," Professor Cho said.

 

"However, the data alone when there is no biomarker is far more competitive than the existing treatment." Previously, there were no lung cancer treatments that demonstrated a 30% response rate and a duration of 10 months in patients who failed Tagrisso treatment.

 

For example, the most prescribed combination of Tagrisso and MET inhibitor Savolitinib is 30% response rate and 7.9 months response duration when only MET patients are selected.

 

Professor Cho compared this data to boxing.

 

It's nothing short of winning Mike Tyson.Treatment of non-small cell lung cancer, which has developed new resistance after Tagrisso administration, is quite difficult due to tumor heterogenicity.

 

This means that the data has increased over a long period of tracking for cancer patients with such malignant conditions.

 

Professor Cho said that there is a good chance that Lazertinib+Amivantamab combined therapy will be designated as a U.S.

 

FDA innovative therapy (BTD) within this year.

 

If similar levels of data are reproduced in Janssen's ongoing CHRYSALIS-2 clinical trial, FDA approval will not be long.