Subsidised treatment options are set to expand for prostate cancer and renal cell carcinoma, with two new listings on the PBS.

Among the changes is the first ever listing of a combination of an immunotherapy and tyrosine kinase inhibitor (TKI) for first-line treatment of certain adult patients with stage IV clear cell variant renal cell carcinoma (RCC).

The pembrolizumab and lenvatinib combination is now available thanks to its addition to the schedule a month ago, following a recommendation by PBAC last March.

This was based on data including from the CLEAR/KEYNOTE-581 trial, which satisfied the committee that the combination was likely non-inferior to nivolumab plus ipilimumab in terms of overall survival.

It also had a “different, yet non-inferior, safety profile”, the PBAC said at the time.

The streamlined authority listing is under Section 100 (Efficient Funding of Chemotherapy Program), with the following eligibility criteria:

• Patient must have a prognostic International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) survival risk classification score at initiation with this drug of either: (i) 1 to 2 (immediate risk), (ii) 3 to 6 (poor risk); document the IMDC risk classification score in the patient’s medical records AND
• The condition must be untreated AND
• Patient must have a WHO performance status of 2 or less AND
• [Existing patients] Patient must be undergoing combination therapy consisting of: (i) pembrolizumab, (ii) lenvatinib; OR
• Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to other drug combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient’s medical records.

In a media release for the drugs’ sponsors, MSD and Eisai Australia, Macquarie University director of clinical trials and medical oncology head Dr Howard Gurney said the move was significant.

“Both immunotherapy and tyrosine kinase inhibitors play a role in the treatment of advanced kidney cancer,” he said.

“This will be the first time that the combination of an anti-PD-1 with a tyrosine kinase inhibitor will be made available on the PBS, providing another treatment option for eligible patients with RCC.”

Meanwhile, patients with metastatic hormone-sensitive prostate cancer (mHSPC) will gain access to apalutamide (Erlyand) through the PBS from 1 June.

The a nonsteroidal antiandrogen is the first drug of its kind to be included on the PBS for mHSPC, the medicine was listed on the basis that apalutamide plus androgen deprivation therapy (ADT) provides a moderate clinical benefit compared to ADT alone, according to the PBAC decision summary.

The therapy should also be made available for use regardless of disease volume or suitability for docetaxel, the committee advised.

The listing application received strong support from MOGA, which categorised apalutamide’s mHSPC indication as one of the therapies of “highest priority for PBS listing” on the basis of the TITAN trial.

Submissions from prostate cancer support groups described a range of benefits of treatment with apalutamide plus ADT including the improved efficacy in terms of overall survival compared to the current standard of care, ADT.

“The PBAC also noted that a number of comments described the improved quality of life associated with apalutamide +ADT compared to docetaxel or other chemotherapy including improved tolerability and the ease of taking an oral medication compared to injectable chemotherapy,” the decision summary states.

Around 3,000 patients each year are expected to access the drug under the listing, according to the federal government.