Nivolumab (Opdivo) has become the first immunotherapy to be listed on the PBS for the treatment of patients with advanced or metastatic gastro-oesophageal cancers.
From October 1, 2022 the PD-1 inhibitor is reimbursed for use in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with HER2 negative advanced or metastatic gastric cancer (GC), gastroesophageal junction cancer (GOJC), or oesophageal adenocarcinoma (OAC).
The listing was recommended by the PBAC at its March 2022 meeting, when the committee acknowledged trial data showing a significant improved overall survival (OS) in patients treated with nivolumab plus chemotherapy, compared to chemotherapy alone.
The Checkmate 649 trial showed that median overall survival was 13.83 months for nivolumab treated patients compared to 11.56 months for patients in the chemotherapy only group (Hazard Ratio 0.80 [0.68, 0.94] P=0.0002).
The Medical Oncology Group of Australia (MOGA) expressed its strong support for the nivolumab PBS listing submission, categorising it as one of the therapies of “highest priority for PBS listing”.
Oesophageal and gastric cancers have amongst the worst five year survival rates of all cancers in Australia (24% and 28%, respectively), the PBAC noted.
Medical oncologist Professor Stephen Clarke of GenesisCare, Sydney, said the reimbursement of a new treatment option for this patient group represented a major milestone in addressing a significant unmet need.
“These cancers are often diagnosed late and patients traditionally have very poor outcomes, with no treatment advances for this patient group in the past decade,” said Professor Clarke in a media statement from of nivolumab makers Bristol-Myers Squibb.
“Trial data has demonstrated the combination of these mechanistically different therapies results in clinically meaningful outcomes for patients living with these types of upper gastrointestinal cancer,” he said.
“As clinicians, we welcome the availability of additional therapy options for these patient groups, who historically have faced poor prognoses and limited access to novel treatments,” said Prof Clarke.
An estimated 2,572 new cases of gastric cancer (including GOJC) are diagnosed in Australia annually and 1,146 Australians would die from this cancer, according to BMS. For oesophageal cancer (including both squamous cell carcinoma and adenocarcinoma), these numbers were estimated at 1,725 new cases and 1,394 deaths in 2022.