Olaparib and durvalumab in patients with germline BRCA-mutated metastatic breast cancer (MEDIOLA): an open-label, multicentre, phase 1/2, basket study.

BACKGROUND: Poly (ADP-ribose) polymerase inhibitors combined with immunotherapy have shown antitumour activity in preclinical studies. We aimed to assess the safety and activity of olaparib in combination with the PD-L1-inhibitor, durvalumab, in patients with germline BRCA1-mutated or BRCA2-mutated metastatic breast cancer. METHODS: The MEDIOLA trial is a multicentre, open-label, phase 1/2, basket trial of durvalumab and olaparib in solid tumours. Patients were enrolled into four initial cohorts: germline BRCA-mutated, metastatic breast cancer; germline BRCA-mutated, metastatic ovarian cancer; metastatic gastric cancer; and relapsed small-cell lung cancer. Here, we report on the cohort of patients with breast cancer. Patients who were aged 18 years or older (or aged 19 years or older in South Korea) with germline BRCA1-mutated or BRCA2-mutated or both and histologically confirmed, progressive, HER2-negative, metastatic breast cancer were enrolled from 14 health centres in the UK, the USA, Israel, France, Switzerland, and South Korea. Patients should not have received more than two previous lines of chemotherapy for metastatic breast cancer. Patients received 300 mg olaparib in tablet form orally twice daily for 4 weeks and thereafter a combination of olaparib 300 mg twice daily and durvalumab 1·5 g via intravenous infusion every 4 weeks until disease progression. Primary endpoints were safety and tolerability, and 12-week disease control rate. Safety was analysed in patients who received at least one dose of study treatment, and activity analyses were done in the full-analysis set (patients who received at least one dose of study treatment and were not excluded from the study). Recruitment has completed and the study is ongoing. This trial is registered with ClinicalTrials.gov, NCT02734004. FINDINGS: Between June 14, 2016, and May 2, 2017, 34 patients were enrolled and received both study drugs and were included in the safety analysis. 11 (32%) patients experienced grade 3 or worse adverse events, of which the most common were anaemia (four [12%]), neutropenia (three [9%]), and pancreatitis (two [6%]). Three (9%) patients discontinued due to adverse events and four (12%) patients experienced a total of six serious adverse events. There were no treatment-related deaths. 24 (80%; 90% CI 64·3-90·9) of 30 patients eligible for activity analysis had disease control at 12 weeks. INTERPRETATION: Combination of olaparib and durvalumab showed promising antitumour activity and safety similar to that previously observed in olaparib and durvalumab monotherapy studies. Further research in a randomised setting is needed to determine predictors of therapeutic benefit and whether addition of durvalumab improves long-term clinical outcomes compared with olaparib monotherapy. FUNDING: AstraZeneca.

An Update from the Benchmark Survey of phactMI™ Member Companies on Providing Medical Information in the Digital Space.

OBJECTIVE: The Pharma Collaboration for Transparent Medical Information (phactMI™) benchmarking survey of 32 pharmaceutical companies describes the use of technology by Medical Information Departments. METHODS: A survey was distributed to phactMI™ member companies in June 2022 and included 79 closed and open-ended questions. The survey's six sections included demographics, chatbot, social media, instant messaging applications, websites, and technology. RESULTS: Most Medical Information Departments have implemented innovative technology since 2019 with the main driver of remaining up-to-date. A total of 94% have a Medical Information website. Of those with a Medical Information website for healthcare professionals (HCPs), 97% allow for self-authentication. Most HCP-based websites have webforms for inquiries and 1-800 numbers, while only few offer video chat, chatbot, and the ability to identify local representatives. These websites also link to clinicaltrials.gov, publications, posters, and congress materials. Only 30% have a website for patients/caregivers. Most websites are discoverable by Google™. Awareness of Medical Information Websites occurs in a variety of ways, with most using multiple strategies to reach HCPs. There is wide variation in the technology platform used for the core functions of Medical Information. CONCLUSION: As technology continues to advance and omnichannel content remains a key objective, Medical Information needs to remain agile and transformative in their strategic and tactical planning and execution. Based on this benchmarking survey, the authors recommend that Medical Information Departments focus on expanding services for patients/caregivers, leverage digital innovations, expanding awareness, building efficiencies in workflow through technology, and continually improving website functionalities with innovative technologies.