Clinicians welcome expanded indication for BMS’ melanoma treatment

Pharma News: Bristol Myers Squibb Australia (BMS) is today welcoming the expanded Pharmaceutical Benefits Scheme (PBS) reimbursement of Opdivo (nivolumab) plus Yervoy (ipilimumab) to include patients with unresectable Stage III or IV malignant melanoma who have experienced disease recurrence whilst on, or within, six months of completion of adjuvant PD-1 inhibitor treatment.

According to Professor Georgina Long AO, dermatologist and Co-Medical Director of Melanoma Institute Australia (MIA), the listing helps to address a significant unmet clinical need for high-risk patients.

“Prior to today’s listing, melanoma patients who recurred while on, or within 6 months of, adjuvant anti-PD-1 therapy had limited treatment options, and were unable to access PBS-funded standard of care when they recurred, representing a high unmet clinical need,” said Prof Long.

“Today’s PBS announcement is a significant milestone for the melanoma community, and as clinicians, we welcome the availability of an additional treatment option for this patient group.”

Last year, the MIA collaborated with BMS, MSD and Novartis to launch the landmark melanoma report. It estimated that without critical action being taken, by 2030 a further 14,000 Australians will die from melanoma, 205,000 will be diagnosed with the disease, and the economic cost to the nation will be $8.7 billion. The report also highlighted that melanoma deaths in Australia exceed the road toll (1,384 vs 1,113), yet road safety funding dramatically exceeds melanoma awareness and prevention funding.

According to Leah Goodman, General Manager, Bristol Myers Squibb Australia, the support provided by the broader melanoma community was paramount in this PBS submission.

“BMS Australia acknowledges the collective efforts of the Medical Oncology community, patients, carers, and patient organisations who contributed to, and advocated for this listing.

“This PBS reimbursement provides broad, and equitable access to immunotherapy options for metastatic melanoma patients. We are proud of our efforts to address this unmet medical need, shaping the market to drive change for these most at risk patients,” Ms Goodman said.

At the American Society of Clinical Oncology (ASCO) Meeting 2022, Professor Long delivered an oral plenary session on the RELATIVITY-047 clinical trial, which showed the effectiveness of BMS’ Opdualag, a fixed-dose combination of LAG-3 inhibitor relatlimab and PD-1 immune checkpoint inhibitor Opdivo (nivolumab), for previously untreated advanced melanoma patients. The combination therapy continued to demonstrate a progression free survival (PFS) benefit vs monotherapy in patients with previously untreated metastatic or unresectable melanoma, consistent with the primary analysis. The combination treatment demonstrated a 20% reduction in risk of death and numerically improved overall survival (OS) rates, although statistical significance was not reached for this secondary endpoint.

Despite approvals in other countries, in July 2022, the PBAC did not recommend the listing of Opdualag for the treatment of patients with unresectable Stage III or IV malignant melanoma noting that “there is a low clinical need for Opdualag as there are existing effective treatment options available on the PBS” including BMS’ Opdivo and MSD’s Keytruda as monotherapy and BMS’ Yervoy + Opdivo in combination therapy.”

In reimagining healthcare across the entire patient journey, Health Industry Hub^TM is the only one-stop-hub bringing the diversity of Pharma, MedTech, Diagnostics & Biotech sectors together to inspire meaningful change.

The content on Health Industry Hub is copyright protected and should only be accessed under individual user licenses. To subscribe, please click here and visit T&Cs here.