Cancer immunotherapy combo seeks 1st-line reimbursement

ONO·BMS applies for reimbursement of ‘Opdivo’ and ‘Yervoy’ combination

Not enough first-line treatment options available in NSCLC…whether the combination will be put up for deliberation by the Review Committee for Cancer Disease is receiving attention

Activity to reimburse ‘Opdivo’ has begun again after a long standstill.

 

According to industry sources, Ono and BMS recently submitted an application to extend reimbursement for the PD-1 inhibitor ‘Opdivo (nivolumab)’ in combination with the CTLA-4 inhibitor ‘Yervoy (ipilimumab)’ to first-line treatment of non-small cell lung cancer (NSCLC).

 

This is the first time in a long while that a discussion for listing Opdivo is being resumed in the field of lung cancer since Opdivo’s reimbursement attempt to receive reimbursement ‘as monotherapy for second-and third-line treatment of lung cancer regardless of PD-L1 expression’ was turned down by the authorities in 2019.

 

The Opdivo and Yervoy combination has initially been approved in Korea for the renal cell carcinoma indication, and its listing process is currently underway.

 

As with MSD’s ‘Keytruda (pembrolizumab),' Ono and BMS had discontinued the reimbursement extension discussions as they were unable to accept the condition set by the government requesting the company to ‘cover the initial 3 cycles’ worth of administration cost.' Whether Opdivo will be able to be listed for reimbursement with the new ‘cancer immunotherapy combination' card is receiving attention.

 

Also, with the PD-L1 inhibitor ‘Tecentriq (atezolizumab)’ and Keytruda’s reimbursement as first-line treatment for lung cancer expected to be discussed in July at HIRA’s Review Committee for Cancer Diseases meeting, whether Opdivo will also be put as an agenda for deliberation then remains to be seen.

 

Opdivo in NSCLC was approved in Korea ▲ as first-line treatment of advanced or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy and 2 cycles of platinum-based chemotherapy; and ▲as first-line treatment of metastatic or recurrent NSCLC expressing PD-L1 (≥1%) with no EGFR or ALK genomic tumor aberrations, in combination with Yervoy.

 

Opdivo’s efficacy in lung cancer was confirmed through the two Phase III trials, CheckMate-227 and CheckMate-9LA.

 

Dr.

 

Dae-ho Lee, Professor of Oncology at the Asan Medical Center, said, “The newly approved combination therapies that use Opdivo have clinical significance not only because it raises the treatment response rate and improves the period of survival in NSCLC patients, but because it also provides more treatment strategy options to first-line NSCLC patients.

 

However, one thing left to be desired is that we lack discovery of appropriate biomarkers that can guide us through the various treatment strategies." he said.