“Access to Onivyde should improve for more options"

[Interview] Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center

NOPOLI-1 subset analysis in Asian patient group found the treatment more effective

RWE in South Korea shows similar outcomes

“Besides the findings from global clinical study on treating metastatic pancreatic cancer patients, Onivyde even offers subset analysis on Asian patients and real-world evidence (RWE) in South Korea.

 

It is regretful the treatment has not been listed for National Health Insurance (NHI) reimbursement.”

Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center

On Aug.

 

20, Professor Yoo Chang-hoon of Oncology Department at Seoul Asan Medical Center commented so, when explaining the clinical profile of Onivyde (liposomal irinotecan hydrochloride).

 

Currently indicated as a combination therapy with 5-fluorouracil (5-FU) and Leucovorin (LV) in treating a patient with metastatic pancreatic cancer who has failed to respond in Gemcitabine-based therapy, Onivyde has accumulated meaningful clinical evidence to prove itself as an effective later-line treatment for patients who struggled with the first-line treatment.

 

The Phase III NAPOLI-1 study conducted in 14 countries around the world provided the outcome.

 

The study found, when Onivyde plus 5-FU/LV therapy was given to patients with metastatic pancreatic cancer who has previously received Gemcitabine-based chemotherapy, the median overall survival (mOS) was 6.1 months, which is about 1.5 times longer than 4.2 months in 5-FU/LV therapy only group.

 

The patient group with Onivyde combination therapy demonstrated median progression-free survival (mPFS) of 3.1 months, compared to 1.5 months in the 5-FU/LV therapy only group Professor Yoo noted Onivyde would be even more effective in Asian race.

 

After separately analyzing Asian patients from NAPOLI-1, the clinical researchers found the Onivyde combination therapy demonstrated 8.9 months of mOS and 4 months of mPFS, which was superior to the other patient groups in the study.

 

However, the subset Asian patients using the Onivyde combination therapy marked 8.8% in objective response rate (ORR) indicating the general reduction of tumor size.

 

The figure was lower than the other patients groups at 16.2%.

 

Professor Yoo elaborated, “Although the Asian group had lower ORR, the most important indicators of the efficacy are OS and PFS,” and “The outstanding outcomes from these endpoints could mean Onivyde is more effective to Asian patients.”

Product image of Onivyde

From the safety’s perspective, Asian patient group, compared to other patient groups, had half the frequency of adverse reactions in digestive system like vomiting or diarrhea, but the their drop in white blood cell count doubled that of the other groups.

 

Professor Yoo commented, “The decrease in white blood cell count does not significantly affect a patient’s quality of life as long as they do not have fever.

 

Generally the toxicity was similar, but the common adverse reactions in the Asian patients seemed to not too bothersome for the patient’s quality of life.” In fact, a retrospective real-world evidence study conducted on 86 patients administered with Onivyde in South Korea had similar outcomes as the NAPOLI-1 subgroup analysis data.

 

Nevertheless, Onivyde is still not covered by the NHI.

 

Professor Yoo noted the patients are in agony as the NHI coverage is barely applied on the expanded second-line treatments and technically more effective options.

 

Professor Yoo stated, “When consulting with many of the pancreatic cancer patients, we talk about second and third-line treatments a lot.

 

Without the NHI coverage, we have to discuss about their private medical insurance,” and “It is regretful that Onivyde, despite its abundant evidences from Phase III global clinical study, Asian patient subgroup analysis, and RWE in South Korea, is still not covered by the health insurance benefit.”