Opdivo (Nivolumab) Receives 1st August PBS Listings For Advanced Lung Cancer And Advanced Kidney Can

OPDIVO® becomes the first and only immuno-oncology therapy PBS listed for advanced lung and kidney cancer^1,2

Federal Government confirms PBS listings quickly to give patients affordable access to new treatment

OPDIVO® now PBS listed for three indications across melanoma, lung and kidney cancer ^1,2

Sunday 30^th July 2017 – Bristol-Myers Squibb today announced that OPDIVO® (nivolumab) will be listed on the Pharmaceutical Benefits Scheme (PBS) from 1^st August for locally advanced or metastatic non-small cell lung cancer (NSCLC) and advanced (stage IV) clear cell variant renal cell carcinoma (RCC)^1,2.

The PBS listings represent the first time patients with advanced NSCLC and RCC will have PBS reimbursed access to immuno-oncology therapy.

The 1^st August PBS listing of OPDIVO® is for patients with locally advanced or metastatic NSCLC (advanced lung cancer) who have progressed on or after prior platinum based chemotherapy^1,2 .

The PBS listing in advanced kidney cancer is for patients with stage IV clear cell variant RCC, after prior tyrosine kinase inhibitor (TKI) therapy in adults^1,2.

Brent Pfeiffenberger, General Manager for Bristol-Myers Squibb Australia and New Zealand, welcomed both PBS listings and commended the Federal Government on a quick decision following positive recommendations by the PBAC in March.

"OPDIVO® will be the first and only immuno-oncology therapy with a PBS listing for advanced lung and advanced kidney cancer. The Federal Government has listened to these communities and acted quickly to give eligible patients reimbursed access to a treatment that is improving survival," said Brent Pfeiffenberger.

"At Bristol-Myers Squibb, we are driven to work with speed to help more cancer patients.  With the addition of advanced lung and advanced kidney cancer, we have expanded the PBS listing of OPDIVO® in Australia to include three distinct types of advanced cancer – kidney cancer, melanoma and lung cancer.  OPDIVO® is cementing immuno-oncology as an established treatment option in the fight against cancer," said Brent Pfeiffenberger.

Lung cancer is the leading cause of cancer death in Australia³ with 8,000 people dying from the disease each year³.  Around 80-85% of diagnosed lung cancers are NSCLC ⁴ with the non-squamous form of NSCLC diagnosed in the majority of cases⁴.

Around 3,500 new cases of kidney cancer are diagnosed every year in Australia⁵, with approximately 75% confirmed as clear cell variant RCC⁶.

Patient groups welcomed the PBS listing announcements that give patients with advanced NSCLC and advanced RCC reimbursed access to immuno-oncology therapy.

"Lung cancer is a devastating disease that kills more Australians than any other cancer; more even than melanoma, prostate and breast cancer combined. The lack of treatment options, especially in later stages of the disease, has resulted in a significant unmet medical need that had to be addressed," said Heather Allan, CEO of Lung Foundation Australia.

"This makes the PBS listing of OPDIVO® in advanced lung cancer all the more welcome and we congratulate the Government for making a quick decision that will help thousands of patients," said Heather Allan.

Kidney Health Australia, the peak body dedicated to helping Australians affected by kidney diseases also welcomed the PBS listing confirmation.

"We’re delighted the Government has acted quickly to confirm the PBS reimbursement of OPDIVO® for advanced kidney cancer. This group of patients have been short on good news in recent times, but the PBS listing of OPDIVO® has the potential to make a significant difference to them and their families," said Mikaela Stafrace, CEO Kidney Health Australia.

The lung cancer PBS listing provides another treatment option for Australian patients with locally advanced or metastatic NSCLC who have progressed on or after prior chemotherapy, irrespective of their PD-L1 biomarker status¹. The safety and efficacy of nivolumab as treatment for locally advanced or metastatic NSCLC vs docetaxel was evaluated in two phase 3, randomised clinical trials CheckMate-017 (squamous NSCLC) and CheckMate-057 (non-squamous NSCLC) that enrolled patients regardless of their PD-L1 status.¹ CheckMate-057 enrolled stage IIIB or IV non-squamous NSCLC patients who had progression during or after prior platinum-based doublet chemotherapy (and targeted therapy if they had known EFGR or ALK mutations), patients given nivolumab had significantly improved median overall survival vs the docetaxel arm (12.2 vs 9.4 months, HR, 0.73; p=0.002) ⁷.  At one year, the overall survival for the nivolumab group was 51% vs 39% in the docetaxel arm⁷. At 18 months, the overall survival was 39% in the nivolumab group vs 23% in the docetaxel group⁷. Patients in the nivolumab group experienced fewer grade 3-4 treatment-related adverse events (10%) compared to the docetaxel group (54%)⁷.

In a phase 3 study known as Checkmate 025, patients with metastatic clear cell RCC who were treated with nivolumab, after progression on prior therapy , had a significant median overall survival compared to those who received everolimus (25 months versus 19.6 months, HR, 0.73; p=0.002)⁸. The 12 month OS for nivolumab group was 76% compared to everolimus group at 66.7% ^1,8.  Additionally, nivolumab provided an improved quality of life compared to everolimus and patients experienced fewer grade 3-4 treatment-related side effects (19%) compared to everolimus (37%)⁸.

About OPDIVO’s safety

OPDIVO® is administered as an intravenous infusion every 2 weeks, based on a patient’s body weight (3mg/kg)¹. Treatment with OPDIVO® continues for as long as the patient keeps benefitting from it or can no longer tolerate the treatment¹.

OPDIVO® acts on the immune system and may cause inflammation¹. Inflammation may cause serious damage to a patient’s body and some inflammatory conditions may be life-threatening¹. The most common adverse events reported in clinical studies for OPDIVO® monotherapy across tumour types were fatigue (32%), rash (18%), pruritis (13%), diarrhoea (13%) and nausea (13%)¹. OPDIVO should be used with caution in patients with immune system conditions or who are taking immune-suppressing medicines¹.

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.