MOGA backs earlier access to Novartis’ radioligand therapy in prostate cancer

The Medical Oncology Group of Australia (MOGA) is backing Novartis’ application to the Medical Services Advisory Committee (MSAC) to expand access to its radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) earlier in the treatment pathway for men with metastatic castration-resistant prostate cancer (mCRPC).

MOGA argues that the current treatment paradigm for Pluvicto therapy should be broadened, with the existing listing which requires use either before or after docetaxel chemotherapy, reconsidered. Emerging evidence demonstrates that Pluvicto extends survival while maintaining quality of life, with limited toxicity in patients treated both before and after docetaxel.

Around one in six Australian men will be diagnosed with prostate cancer during their lifetime, making it the nation’s most common cancer among men. Metastatic castration-resistant prostate cancer represents one of the most challenging stages of the disease, with studies indicating an average survival of approximately three to four years.

Under current Pharmaceutical Benefits Scheme (PBS) criteria, treatment with androgen receptor pathway inhibitors (ARPIs) is restricted to a single lifetime course. As a result, men with mCRPC who progress following ARPI therapy and remain taxane-naive have limited treatment options beyond docetaxel chemotherapy or palliative care.

MOGA contends that greater flexibility in the sequencing of Lu-PSMA therapy is clinically warranted. The organisation notes that the optimal use of Pluvicto is nuanced and should reflect individual patient circumstances rather than a rigid treatment algorithm.

For some patients, the benefit of docetaxel may be limited because of comorbidity burden or patient preference. In these cases, Pluvicto represents an appropriate and often preferred alternative that avoids the systemic toxicity associated with cytotoxic chemotherapy. Conversely, patients with a high burden of bone disease may derive greater benefit from upfront docetaxel to reduce the risk of long-term bone marrow suppression associated with Pluvicto. According to MOGA, these contrasting clinical scenarios highlight the need for treatment sequencing that enables clinicians to personalise care rather than adhere to mandatory sequencing of chemotherapy relative to radioligand therapy.

Findings from Novartis’ PSMAfore trial showed that patients treated with Pluvicto experienced improved radiographic progression-free survival, a reduced risk of symptomatic skeletal events compared with standard of care (ARPI change), and better quality of life while on treatment.

Pluvicto therapy has been extensively used and investigated in Australia over the past decade, generating substantial clinical experience alongside published evidence supporting its efficacy and tolerability in appropriately selected patients. Through the Australian and New Zealand Urogenital and Prostate (ANZUP) collaborative trials group, Australia has also produced internationally recognised evidence supporting the use of Pluvicto in men with prostate cancer.

Against this backdrop, MOGA confirmed that it fully endorses MSAC’s review of Pluvicto and is encouraging the committee to remove any listing restriction that makes access contingent on prior docetaxel treatment.

“Such flexibility ensures that treatment decisions remain patient centred, evidence based, and responsive to the heterogeneous biological and clinical profiles seen in Australian men with advanced prostate cancer. It likewise addresses the significant inequity faced by patients when considering Lu-PSMA in the post docetaxel setting in Australia,” MOGA said in a statement.

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