UPDATE : Wednesday, October 23, 2019
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‘Yuhan’s Lazertinib promising as 1st-line therapy for NSCLC’
  • By Jeong Sae-im
  • Published 2019.06.18 14:43
  • Updated 2019.06.18 14:43
  • comments 0

Expectations are rising for Lazertinib, an investigational drug that Yuhan Corp. licensed out to Janssen for the treatment of non-small cell lung cancer (NSCLC), an analyst said.

Meritz Securities said in a report on Monday that the market prospect for Lazertinib continued to rise even after the meeting of the American Society of Clinical Oncology (ASCO). The brokerage advised investors to “buy” Yuhan shares, with a target price of 322,000 won ($272) per share.

According to the results of phase-1 and 2 clinical trials on Lazertinib presented during ASCO, the drug showed superior efficacy to that of rival treatment Tagrisso. Patients treated with Lazertinib 120mg doses or higher had 12.3 months of progression-free survival (PFS), whereas the Tagrisso group had 10.1 months.

“It is very encouraging that Lazertinib had over two months longer PFS than Tagrisso,” said Oh Se-jung, an analyst at Meritz Securities. “Currently, the part-C clinical trial is underway using Lazertinib with the optimal dose of 240mg as the first-line and second-line treatment. If it shows higher PFS than Tagrisso’s PFS of 18.9 months as the first-line therapy, we will able to know if Lazertinib will become Best-In-Class drug before the completion of the phase-3 trial.”

Tagrisso won approval as a first-line treatment, but it is usually prescribed as a second-line treatment because the first-line treatment is not reimbursable. Oh said Lazertinib as the first-line treatment in 240mg optimal dose was most promising.

Industry watchers expect that phase-3 global trial on Lazertinib to begin in the fourth quarter in Korea and the first quarter next year in other countries. As Tagrisso was authorized as the first-line treatment in the U.S. and Korea, there is almost no benefit for Janssen to conduct a study to test Lazertinib as a second-line treatment, Oh said.

He said anticipation for Lazertinib for a combo therapy was also growing. At ASCO, Janssen updated phase-1 interim data of JNJ-372, an EGFR (epidermal growth factor receptor)-cMet bispecific antibody. The data showed that 30 percent of patients with EGFR mutations who did not respond to existing EGFR inhibitors had the highest partial response (PR). Serious adverse drug events at Grade 3 or higher occurred in only 9 percent of the patients. Adverse reactions that led to discontinuation of the treatment occurred in 8 percent.

“The drug was effective in mutations that did not respond to existing EGFR inhibitors. It is positive that adverse events occurred within a tolerable level,” Oh said. “As Lazertinib secured safety data, the recent study reduced safety concerns for its use in a combo therapy.”

The phase-1b trial on Lazertinib in combination with JNJ-372 began in the first quarter and is expected to be completed within this year.

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