Janssen’s CAR T granted TGA registration, leaving clinicians astounded by new data in multiple myeloma

Pharma News: Janssen Australia has announced the registration of its CAR T-cell therapy, Carvykti (ciltacabtagene autoleucel), marking a significant milestone in the fight against multiple myeloma. This remarkable therapy is set to bring renewed hope to Australians who have faced the challenges of this relentless disease, having already undergone at least three prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

The registration of Carvykti represents a vital first step toward making this personalised therapy accessible to those who may benefit from it the most.

“We understand the urgency for patients with multiple myeloma in need of Carvykti and are committed to working with all stakeholders to advocate for equitable and timely access to CAR T-cell therapy in Australia,” the company said in a statement.

The importance of Carvykti cannot be overstated, particularly for patients in their first relapse, where conventional treatments often prove ineffective. Revlimid (Lenalidomide) has long been recognised as a vital component of early therapy and maintenance for multiple myeloma patients. However, for those whose disease has become refractory to lenalidomide, options for subsequent lines of therapy have been distressingly limited, leading to a generally bleak prognosis.

But now, new results have emerged from the phase 3 CARTITUDE-4 trial, unveiled at the prestigious American Society of Clinical Oncology (ASCO) 2023 annual meeting, that reveal the remarkable benefits of Carvykti.

Peter Mac was the leading Australian recruitment site for this pivotal Phase III clinical trial which involved 81 hospitals globally – mostly in the US, Europe and Asia.

Patients in the CAR T-cell therapy group were more likely to show an early and deep “complete response” – meaning their blood cancer became undetectable – at 73% compared to 22% for standard-of-care. After one year, progression free survival in the CAR T-cell therapy group was 76% compared to 49% for standard of care.

Principal investigator, Dr Binod Dhakal, from the Medical College of Wisconsin, declared that the hazard ratio for death or progression with Carvykti stood at an unprecedented 0.26 (P < .001), making it the most favourable hazard ratio ever reported in this patient population within a randomised clinical setting.

Professor Simon Harrison, Director of the Centre of Excellence in Cellular Immunotherapy and a leading Haematologist in the Myeloma team at Peter Mac, led the trial in Australia.

“Not only was CAR T-cell therapy more likely to produce rapid and deep initial responses in patients, most of whom had heavily pre-treated myeloma, these responses were also usually more durable than those resulting from standard of care,” said Prof Harrison.

“CAR T-cell therapy represents a significant treatment advance for myeloma, a blood cancer which is still considered to be incurable, with these results even more impressive than those for the MSAC approved CAR T-cell therapies for B-cell acute lymphoblastic leukaemia and aggressive lymphoma. These results, following on from those from the CARTITUDE-1 study, will lead to a change the treatment paradigm for patients with myeloma,” he added.

The ground-breaking data left global experts in the field astounded. Dr Asher Chanan-Khan, from the esteemed Mayo Clinic Cancer Centre in Jacksonville, Florida, expressed his perspective on the findings at ASCO, stating, “Myeloma treatment should be revisited in the light of this.”

Janssen plans to resubmit a reimbursement application to the Medical Services Advisory Committee (MSAC) in June, with the hope that this innovative therapy will be considered in November.

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