Janssen makes EMA marketing application for talquetamab for RRMM

Janssen J&J Johnson and Johnson pharmaceutical companies

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA), seeking approval of talquetamab for the treatment of patients with relapsed or refractory multiple myeloma (RRMM).

Multiple myeloma is an incurable blood cancer that affects plasma cells, a type of white blood cells found in the bone marrow. In multiple myeloma, malignant plasma cells change and grow out of control. In 2020 in Europe, over 50,900 people were diagnosed with multiple myeloma and more than 32,400 died from it.

Talquetamab is an investigational, off-the-shelf (or ready-to-use) bispecific T-cell engager antibody that targets both GPRC5D – a novel drug target that is on some normal cells, but overexpressed on myeloma cells – and CD3 on T-cells. Administered by subcutaneous injection, it is currently being evaluated in several monotherapy and combination studies.

Dr Edmond Chan, senior director EMEA therapeutic area lead, haematology, at Janssen-Cilag Limited, said: “Despite advances, there remains a high unmet need for those with heavily pre-treated multiple myeloma, as only 30% of triple-class exposed patients respond to currently available treatment options.”

He continued: “Innovative treatments approaches such as talquetamab […] are critical for improving outcomes for patients, and we look forward to working with the EMA to bring talquetamab to those in need of new options, as soon as possible.”

The Marketing Authorisation Application comes after the EMA granted talquetamab accelerated assessment in November 2022. This reduces the timeframe for the MAA to be reviewed. It is granted when a medicinal product is of major interest for public health and therapeutic innovation.

The MAA is supported by data from the phase 1 and phase 2, first-in-human MonumenTAL-1 study of talquetamab in patients with RRMM who had received more than three prior lines of therapy. The first phase 2 results were presented at ASH 2022 and phase 1 results were recently published in The New England Journal of Medicine.

At ASH 2022, the data presented showed that subcutaneous talquetamab achieved an overall response rate (ORR) of 74% at a 0.4 mg/kg dose and 73% at a 0.8 mg/kg dose – given every two weeks – in myeloma patients previously treated with a median of five prior lines of therapy. That included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.

Dr Peter Lebowitz, global therapeutic area head, oncology, at Janssen Research & Development, LLC, said: “[The] submission in Europe marks another important milestone in our progress and ambition to transform the treatment of multiple myeloma.”

The MAA to the EMA also follows a Biologics License Application (BLA) to the FDA, made in December 2022.

In October 2022, Johnson & Johnson secured FDA approval for its BCMAxCD3 bispecific antibody for multiple myeloma – Tecvayli – adding to the wide range of therapies available for the blood cancer.