Melanoma management takes a quantum leap with PBAC recommendation for neoadjuvant therapy

Pharma News: In a monumental leap forward in the fight against melanoma, the Pharmaceutical Benefits Advisory Committee (PBAC) has made a recommendation to expand the current Pharmaceutical Benefits Scheme (PBS) listing for Merck Sharp & Dohme’s (MSD) immunotherapy, Keytruda (pembrolizumab). The recommendation allows for the neoadjuvant treatment of resected Stage IIIB, Stage IIIC, or Stage IIID malignant melanoma, representing a historic milestone in the global regulatory landscape.

Professor Richard Scolyer and Professor Georgina Long spearheaded the initiative on behalf of Melanoma Institute Australia (MIA), successfully influencing the regulatory body in the academic community’s first-ever modification to an immunotherapy PBS listing.

Currently, the approved PBS listing for Keytruda necessitates the surgical removal of melanoma tumours followed by adjuvant immunotherapy post-operatively. This approach effectively halved the risk of melanoma recurrence. However, assessing the efficacy of drug treatments on an individual level is challenging under this regimen.

In its assessment, the PBAC noted that the proposed amendment would have minimal financial implications, as the total treatment duration and cost remain unchanged. The committee further advised that treatment in conjunction with complete surgical resection should be limited to the three-week regimen only, ensuring optimal patient outcomes while maintaining fiscal responsibility.

“Whilst this is positive news for Australian melanoma patients and a major advance for neoadjuvant treatment, not everyone responds, so there is still much work to be done and more investment in clinical trials required. Another step towards zero deaths from melanoma,” emphasised Professor Scolyer and Professor Long.

The Private Cancer Physicians of Australia was quick to congratulate MIA on this remarkable achievement, affirming that it represents the most significant breakthrough in melanoma treatment since the inception of immunotherapy. The impact of this development cannot be overstated, as it promises to revolutionise the standard of care and redefine the way medical professionals approach melanoma treatment.

The findings stem from a study which aggregated data from six clinical trials involving the administration of anti-PD-1-based immunotherapy or BRAF/MEK targeted therapy as neoadjuvant therapy prior to surgery. The research team made a ground-breaking discovery: providing Stage III patients with a short course of pre-operative targeted or immunotherapy proved highly effective. Moreover, the study revealed a direct correlation between patients’ initial response to treatment within the first six to nine weeks and the likelihood of their disease not recurring after surgery.

Incredibly, the study demonstrated that among the patients who responded favourably to dual immunotherapy administered prior to surgery, a mere 3% experienced tumour recurrence following the surgical procedure, indicating that an impressive 97% were likely cured. These results have generated widespread enthusiasm within the medical community, offering renewed optimism for patients battling this formidable disease.

Professor Long, Co-Medical Director of MIA and senior author of the study, remarked, “The neoadjuvant approach represents a paradigm shift in melanoma treatment, particularly for Stage III patients with bulky disease that has spread to their lymph nodes. By employing our arsenal of cutting-edge treatments prior to surgical intervention, we are effectively halting melanoma in its tracks, preventing its recurrence, and thwarting its spread to distant organs. It is a game-changer.”

A/Professor Alexander Menzies, study co-author, said “This study conclusively demonstrates that administering drug therapy before surgery significantly reduces the risk of recurrence, further safeguarding patients against the spread of melanoma to critical organs such as the brain and liver. Lives will be saved as a result. Additionally, we can now accurately evaluate the treatment’s effectiveness for each patient, enabling us to tailor subsequent therapies and follow-up accordingly.”

MIA has played an instrumental role in pioneering neoadjuvant drug therapy, acting as a foundational member of the International Neoadjuvant Melanoma Consortium (INMC). The ground-breaking study represents the first extensive analysis of immunotherapy in the neoadjuvant setting across all cancers, potentially laying the groundwork for the pre-operative use of immunotherapy in numerous other cancer types.

Australia, with the highest melanoma rates globally and a shocking diagnosis rate of one person every 30 minutes, stands to benefit greatly from this PBAC recommendation. Alarmingly, an estimated 1,300 people are projected to lose their lives to melanoma in Australia this year alone. However, with the remarkable advancements witnessed in the treatment of melanoma over the past decade, the positive impact is now extending to individuals with earlier-stage disease.

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