First checkpoint inhibitor PBS listed to treat MSI-H or dMMR bowel cancer

Pharma News: From 1 August 2021, Australians diagnosed with a specific type of bowel cancer will have access to MSD’s anti-PD-1 immuno-oncology therapy on the Pharmaceutical Benefits Scheme (PBS)

Keytruda was approved by the Therapeutic Goods Administration (TGA) earlier this year for the first-line treatment of patients with unresectable or metastatic bowel cancer (CRC) that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) as determined by a validated biomarker test.

Julien Wiggins, CEO Bowel Cancer Australia, welcomed the availability of Keytruda on the PBS for this subset of bowel cancer patients.

“This PBS listing of Keytruda is the first immunotherapy to be subsidised for bowel cancer patients living with this rare subtype of bowel cancer. No longer will patients and their families be faced with the decision of whether to go into debt to fund this treatment, or to decline it.”

This approval is based on results from the pivotal Phase 3 KEYNOTE-177 trial, in which Keytruda monotherapy significantly reduced the risk of disease progression or death by 40% (p=0.0002) compared with chemotherapy with or without bevacizumab or cetuximab. In the trial, treatment with Keytruda also more than doubled median progression-free survival (PFS) compared with chemotherapy (16.5 months versus 8.2 months).

Professor Peter Gibbs, from Western Health in Melbourne, specialises in treating patients with bowel cancer and welcomed the news.

“This is the first subsidised immuno-oncology treatment option for patients with this type of bowel cancer. As a clinician, it is often challenging to present treatment options to patients that may be financially out of reach, therefore it is important news for patients and clinicians alike that this treatment is now on the PBS,” stated Professor Gibbs.

Ms Anna Morris, 34 years old from Melbourne, was diagnosed with metastatic bowel cancer at the age of 28.

“My cancer diagnosis came as a shock as I had no relevant clinical history. I was only diagnosed with bowel cancer after being treated for a blood clot in my arm, which was due to the cancer already spreading to another part of my body.

“After biomarker testing, the results showed that immuno-oncology therapy was a treatment option for me. With the financial support of my family, I was able to access Keytruda but I know that isn’t always an option for some patients. I am excited to hear that certain metastatic bowel cancer patients now have subsidised access to this immuno-oncology treatment.”

MSD Managing Director for Australia and New Zealand, Mr Michael Azrak, said this latest PBS listing for Keytruda is important news for eligible Australian bowel cancer patients, their loved ones, their carers, and their treating clinicians.

“This PBS listing of Keytruda is the therapy’s 10th subsidy in Australia. I continue to be humbled by the impact PBS listings have on the lives of Australians. MSD will continue to work hard to ensure eligible Australian patients with cancer have subsidised access to an immuno-oncology treatment option,” said Mr Azrak.

“I would like to thank the Minister for Health and Aged Care, the Honourable Greg Hunt MP for listing this treatment option on the PBS for eligible bowel cancer patients. Providing patients with timely and affordable access to medicines through the PBS is what motivates me and each of my colleagues at MSD.

“This PBS listing was announced approximately 230 days after Keytruda was registered for this indication by the TGA. Some new medicines in Australia can take up to 410 days from registration to be listed on the PBS, however this listing indicates that registration to reimbursement timelines for new medicines in Australia can be accelerated. We are committed to working with the Australian Government to continue to get medicines to patients sooner through the PBS” said Mr Azrak.

An estimated 15,000 Australian patients will be diagnosed with bowel cancer each year. In 2020, there were an estimated 5,300 deaths from bowel cancer, making bowel cancer the second leading cause of cancer death in Australia.