21 September 2018 - Opdivo now approved in Australia for eleven indications across seven cancer areas in under three years.

Bristol-Myers Squibb today announced that the TGA has registered Opdivo (nivolumab) as monotherapy, for the treatment of patients with hepatocellular carcinoma (liver cancer) after prior sorafenib therapy. This indication is approved based on objective response rate and duration of response in a single arm study. An improvement in survival or disease-related symptoms has not been established.1,2

This latest indication means Opdivo is the first Immuno-Oncology (I-O) therapy approved in Australia for hepatocellular carcinoma (HCC).1,2 The TGA approval also marks the seventh new cancer area for this immuno-oncology (I-O) therapy.1,2

Liver cancer is the 7th most common cause of cancer death in Australia with an estimated 2,088 patients expected to die from the disease in 2018.3 HCC is the most common type of primary liver cancer and is associated with chronic liver disease and cirrhosis.4

The TGA approval of Opdivo was supported by results from a global Phase 1/2 study (CA209040) 5, which included patients with advanced HCC with or without hepatitis C or B infection, who were previously treated with sorafenib.5 This study demonstrated an overall objective response rate of 14.3% (95% CI 9-21), with 55% of patients showing a duration of response for at least 12 months.5

The toxicity profile observed in patients with advanced HCC was similar to that observed in patients with other cancers, with the exception of a higher incidence of elevations in transaminases and bilirubin levels. Treatment-emergent grade 3 or 4 elevated AST was observed in 18% of patients, grade 3 or 4 elevated ALT in 11% patients, and grade 3 or 4 elevated bilirubin in 7% patients. Immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% patients.1

Associate Professor Simone Strasser, Senior Staff Specialist at the AW Morrow Gastroenterology and Liver Centre, Royal Prince Alfred Hospital, said the introduction of immuno-oncology therapy was welcome news for liver cancer patients and healthcare professionals.

“Primary liver cancer is a rapidly rising cancer in Australia6 and it commonly results in death. There have been limited treatment options for patients with advanced stages of disease. The introduction of an immuno-oncology therapy is an important development for this serious cancer.”

“The TGA approval of Opdivo provides us with an encouraging approach and a new treatment option for appropriate patients with liver cancer that has not been controlled with prior therapy,” said Associate Professor Simone Strasser.

Opdivo as a treatment for patients with HCC after prior sorafenib therapy is not listed on the Pharmaceutical Benefits Scheme (PBS).

Dr Jonathan Anderson, Medical Director, Bristol-Myers Squibb Australia and New Zealand, said this latest TGA registration was testament to the importance of research into new applications of I-O therapy.

“There has been growing interest in leveraging immuno-oncology knowledge and discoveries into treatment options for patients with advanced-stage liver cancer. There is clearly a high unmet medical need and this latest TGA registration for Opdivo will bring I-O treatment one step closer for HCC patients.”

In Australia, Opdivo is approved by the TGA for eleven indications across seven distinct tumour types. 1,2 In addition to HCC, Opdivo is approved in melanoma, advanced lung cancer, advanced renal cell carcinoma, advanced bladder cancer, advanced head and neck cancer and relapsed/refractory classical Hodgkin lymphoma.1,2

About clinical study CA209040

CA209040 is a phase 1/2, non-comparative study, dose escalation and expansion trial of nivolumab in adults with histologically confirmed advanced HCC with or without hepatitis C or B infection. The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced HCC in patients previously treated with sorafenib was established in a 154-patient subgroup of this study.

About Immuno-Oncology (I-O)

Immuno-oncology is based on the premise that the immune system is the body’s most powerful and effective tool for recognising and fighting disease. Immuno-oncology treatments are designed to harness the patient’s own immune system to combat cancer by targeting the same immune pathways that tumour cells use to evade recognition and destruction.

About Opdivo’s safety

Opdivo is administered as an intravenous infusion every 2 weeks, based on a patient’s body weight (3mg/kg). Opdivo acts on the immune system and may cause inflammation. Inflammation may cause serious damage to a patient’s body and some inflammatory conditions may be life-threatening. The most frequent adverse events reported for Opdivo include fatigue, rash, pruritus, diarrhoea, musculoskeletal pain, arthralgia, hypothyroidism and nausea.

Further information about Opdivo can be found in the Product Information – September 2018.