Lung Cancer News – November PBAC Meeting; International Development and Reimbursement News; ESMO 2016
There are four applications for lung cancer on the November PBAC meeting agenda. Download the full agenda here. The applications are:
- Ceritinib for ALK-positive NSCLC (locally advanced or metastatic) with progression after treatment with an ALK inhibitor
- Nivolumab for (1) squamous and (2) non-squamous NSCLC (locally advanced or metastatic) with progression on or after chemotherapy
- Pembrolizumab for PD-L1 positive NSCLC in patients refractory to platinum-based chemotherapy.
Beakthrough Therapy Designation has been granted by the US FDA for alectinib for patients who have not received prior treatment with an ALK inhibitor. This is based on results of the J-ALEX study conducted by Chugai in Japan, comparing alectinib with crizotinib in 207 Japanese patients with ALK-positive, advanced or recurrent NSCLC who had not been previously treated with an ALK inhibitor. Median PFS was not reached in the alectinib group compared with 10.2 months in those treated with crizotinib and a 66% improvement in PFS (HR 0.34, p<0.0001). There were also more frequent grade 3/4 adverse events in the crizotinib group (51% vs 27%). Source: FiercePharma, company press release.
Osimertinib NICE decision. Osimertinib has been recommended by the UK’s National Institute for Health and Care Excellence (NICE) to be made available through the Cancer Drugs Fund. Osimertinib will be available as a second line treatment for patients with advanced NSCLC expressing the EGFR T790M mutation. Source: FiercePharma, NICE website.
Olmutinib (HM61713) development collaboration ended. This third generation EGFR inhibitor was to be developed as a possible competitor to osimertinib; however following recent reports of severe toxicity, including the death of one patient, Boehringer Ingelheim has handed back the rights to Hanmi Pharmaceutical. Source: FiercePharma.
Data presented at ESMO. Results of KEYNOTE-024 showed pembrolizumab significantly reduced the risk of progression and prolonged overall survival compared with chemotherapy in patients with advanced NSCLC patients and high levels of PD-L1 expression. Read the NEJM article. Greater patient selection may be needed for first line nivolumab to improve progression-free survival over chemotherapy in advanced lung cancer as the CheckMate 026 trial gave negative results in a broad group of patients expressing PD-L1 in their tumour cells. Read the ESMO press release. UPDATE: pembrolizumab has been approved by the US FDA in first-line. Read the company press release.