First line therapy for NSNLC, starts of combination therapy

Cyramza+Tarceva presents alternatives to EGFR exon 19 defects

Opdivo+Yervoy improves overall survival compared to chemotherapy

Various combinations have been approved for NSNLC (non-small cell lung cancer), the most competitive field for new anticancer drugs.

 

Competition is expected to intensify in the future as numerous studies are underway based on immuno-cancer drugs and targeted anti-cancer drugs.

 

Lilly threw the hat into the ring in Korea.

 

The company is in the process of expanding insurance benefits for primary prescriptions of NSCLC of VEGF receptor 2 antagonist Cyramza (Ramucirumab) and epithelial cell growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tarceva (Erlotinib).

 

Cyramza's combination therapy was approved in Korea in July.

 

The new combination targeting VEGF and EGFR is attracting attention because it has shown efficacy in mutant patients such as EGFR exon 19 deletion and exon 21 (L858R), which have been relatively weak so far.

 

The possibility of Cyramza+Tarceva combination therapy was confirmed through a phase III RELAY.

 

The Cyramza+Tarceva combined group reduced the risk of death by 40% compared to the Tarceva alone group, and the combined group showed a difference of more than 7 months from the control group at 19.4 months.

 

Overall survival (OS) has not yet been derived.

 

The median follow-up was 20.7 months, and the objective response rate was 76.3% in the Cyramza combination group and 74.7% in the Erlotinib alone group, but the median response duration was 18.0 months and 11.1 months.

 

It is also encouraging that about 70% of the patients who participated in the RELAY study included East Asians.

 

The immune anticancer drug Opdivo((Nivolumab), which has suffered from wage issues in Korea, is also starting a new challenge.

 

Ono and BMS added a first-line indication for non-small cell lung cancer in combination with PD-1 inhibitor Opdivo and CTLA4 inhibitor Yervoy (Ipilimumab) on the 16th.

 

The effectiveness of Opdivo-Yervoy combination therapy in the first line of NSNLC was confirmed through a Phase 3 CheckMate-9LA study.

 

CheckMate 9LA (NCT03215706) is a phase III randomized study evaluating NIVO + IPI + 2 cycles chemo vs chemo in 1L stage IV/recurrent NSCLC A statistically significant improvement in OS was observed with NIVO + NSCLC-optimized IPI + a limited course of chemo vs chemo (4 cycles) in 1L advanced NSCLC.

 

No new safety signals were reported.

 

In addition, the results of extended follow-up for 12.7 months showed that the median OS of the two cycles of Opdivo+Yervoy chemotherapy was 15.6 months, which was consistently improved compared to 10.9 months of chemotherapy.

 

Meanwhile, Opdivo+Yervoy combination therapy was approved as an indication for renal cell carcinoma in Korea, and it is in the process of registration after passing the Cancer Disease Review Committee in June.

 

Cyramza was listed as a refund-type risk sharing agreement (RSA) in second-line gastric cancer therapy in May 2018.