Himalaya Early Access Program

Overall design This is a multi centre, open-label, early access program (EAP) designed to provide treatment access to intravenous (IV) combination treatment regimen of 300 mg tremelimumab administered IV once on Day 1 of Cycle 1 plus 1500 mg durvalumab IV (MEDI 4736) followed by durvalumab IV monotherapy administered once every 4 weeks (Q4W) for eligible patients with unresectable, hepatocellular carcinoma (HCC). Durvalumab and tremelimumab will be provided free of charge to the patients entering this program. This global EAP will be opened in a staggered fashion, country by country, based on the requesting Treating Physician(s) and local regulations, ending when durvalumab and tremelimumab has received marketing authorisation in first line treatment in patients with unresectable hepatocellular carcinoma. Target patient population Patients with unresectable HCC and Barcelona Clinic Liver Cancer (BCLC) stage B (who are not eligible or no longer suitable for locoregional therapy \[LRT\]) or stage C before entering the EAP. Program period The EAP will enrol patients and provide resupply of durvalumab and tremelimumab until durvalumab and tremelimumab has received marketing authorisation in first line treatment for patients with unresectable HCC as per local regulations. The EAP will be closed to new patients based on local regulations or when commercially reimbursed product is available. After reimbursement is secured, or denial of reimbursement, or decision by the Sponsor to close the enrolment, whichever occurs first, no new patients can be enrolled after this point. In the event that market license approval or reimbursement should not be granted, contingencies will be made to ensure continued drug supply for patients who are still deriving benefit from durvalumab and tremelimumab. Number of patients: The number of patients who will enrol in the EAP is based on approval of unsolicited requests received from the Treating Physician. Program treatment: On Day 1 of Cycle 1, tremelimumab will be administered first followed by durvalumab 1 hour later. Tremelimumab will be given once on Day 1 of Cycle 1. Durvalumab monotherapy is then given Q4W. Duration of treatment: Patients may continue to receive EAP treatment providing they continue to show clinical benefit, as judged by the Treating Physician, in the absence of unacceptable safety concerns until disease progression, toxicity or withdrawal.