Lung Cancer News
November PBAC meeting outcomes saw a positive recommendation for ceritinib, deferral for nivolumab and a “TBD” for pembrolizumab:
- Ceritinib received a positive recommendation for a written Authority Required General Schedule listing for the treatment of ALK-positive NSCLC. It will be listed from February.
- Nivolumab – a recommendation was deferred and a proposal for a Managed Entry Scheme requested.
- Pembrolizumab – the PBAC recommendation will not be made public until the outcome of the TGA review (for marketing approval) is known.
The 2017 round of Cancer Australia’s PdCCRS (Priority-driven Collaborative Cancer Research Scheme) application process is now open.
Applications are invited for the IASLC annual Fellowship and Young Investigators Programs; and the Bonnie J Addario Lung Cancer Foundation (ALCF)-IASLC Joint Fellowship Award (Early Detection of Lung Cancer)
17th WCLC highlights
We asked some of our MAC and SAC members who attended the 17th WCLC in Vienna to nominate their highlights. Here’s what they said:
Anna Nowak, Sir Charles Gairdner Hospital, WA. One of the highlights of the meeting for me was the mesothelioma immunotherapy session. 10 years ago I would have been one of 30 immunotherapy enthusiasts in the room at WCLC. This year, even in a substantial sized room, it was ‘standing room only’ and people were spilling out the doors trying to hear the results of three trials of checkpoint blockade in mesothelioma. That shows how far immunotherapy has come in a decade.
The efficacy of PD-1 blockade as second line therapy in mesothelioma was remarkably consistent across agents (pembrolizumab or nivolumab) – around 20-25% durable responses to single agent therapy, irrespective of PD-L1 expression on the tumour.
The other exciting data was from the phase II LUME-Meso trial of chemotherapy + nintedanib or placebo in first line MPM. This was the first release of the results, which supported the efficacy of an anti-VEGF strategy with an exciting hazard ratio of 0.56 for progression-free survival for patients on nintedanib, with particular hints towards efficacy in the epithelioid population.
Haryana Dhillon, School of Psychology, The University of Sydney, NSW. Virtually @ World Lung: With so many meetings and so little travel funding available, not to mention time, I have benefitted greatly from following international meetings on Twitter. The World Lung Cancer Congress was one of these meetings.
I was starting my day catching up on information shared by colleagues throughout the European Day and into the night.
People were incredibly responsive and generous, answering questions posed over twitter and providing greater detail about presentations when asked. The feeling imbued throughout these discussions was one of hope. Our understanding of lung cancer is increasing, we have more tools to treat it, and patients are doing better. There is so much work to be done, but with our global network we can do it.
Ros Wilson, ALTG Secretariat, QLD. My personal highlights were (1) seeing David LeDuc, Executive Director of the Bonnie J. Adario Lung Cancer Foundation, lean in to the monitor and nod with great interest as Claire Mulvihill, Lung Cancer Support Nurse at the Lung Foundation, presented the Australian Lung MDT Directory; and (2) the presentation of the AURA3 results in which osimertinib treatment increased median PFS from 4.4 to 10.1 months.
Drug development news
- The PD-L1 checkpoint inhibitor atezolizumab (Tecentriq, Roche/Genentech) has been approved by the US FDA in metastatic NSCLC. The approval is based on two studies – OAK (Phase 3) and POPLAR (Phase 2). In the OAK study median OS in the group treated with atezolizumab was 13.8 months compared with 9.6 months (HR 0.74); the study recruited patients with any PD-L1 status. View the FiercePharma article or company press release.
- Merck & Co. has submitted an application to the US FDA for the combination of pembrolizumab with chemotherapy (based on Keynote-012) – this will go through the priority review process.
- In the UK, the NICE (National Institute for Health and Care Excellence) has approved reimbursement of pembrolizumab for patients with PD L1-positive NSCLC previously treated with chemotherapy. Treatment is to be stopped after two years if a patient has no documented disease progression.
- Servier and Pieris Pharmaceuticals have entered into a co-development agreement in immuno-oncology, providing Servier with access to the Pieris pipeline. The lead molecule is PRS-332, a PD-1-targeting bispecific checkpoint inhibitor, currently in preclinical development. View the FiercePharma article or company press release.
- Merck KGaA has licensed in four research and development programmes from Vertex – two clinical stage projects targeting DNA damage and repair, and two preclinical. View the FiercePharma article or company press release.
- AstraZeneca has updated the timelines for the Phase III MYSTIC study (involving durvalumab and tremelimumab in NSCLC) with PFS data expected mid-2017 and OS in 2018. View the FiercePharma article or company press release.
- Takeda has announced it will acquire ARIAD. ARIAD has been developing brigatinib. View the company press release.