French non-profit healthcare network WIN Consortium (WIN) is set to conduct a clinical trial (SPRING) of a new three targeted therapies combination as a first-line treatment for patients with advanced non-small-cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA).
Merck’s avelumab, in combination with Pfizer’s palbociclib and axitinib, will be evaluated in the trial and the combination regimen is expected to be highly potent.
The new targeted tri-therapy approach will be based on existing similar approaches used for AIDS and tuberculosis.
WIN chairman Dr John Mendelsohn said: “Nevertheless, it is important to acknowledge a significant difference between cancer and AIDS which lies in the higher biological complexity and heterogeneity of cancer compared to AIDS.
“In AIDS, one tri-therapy combination is effective for a majority of patients, whereas in cancer it is expected that many combinations will be needed to treat all patients effectively.
“WIN Consortium has developed new technologies for tailoring combinations for each individual patient.’’
The trial will include subjects who are eligible to receive first line platinum-based chemotherapy and will not recruit patients with documented targetable driver alterations such as EGFR mutations, ALK rearrangements, ROS1 and MET exon 14 skipping mutations.
Planned to be performed at eight WIN member sites in five countries, SPRING will initially include a Phase I portion designed to assess the combination’s safety and establish optimal doses for the subsequent Phase II portion.
The Phase II part will explore the efficacy of the combination therapy and will also validate WIN’s new Simplified Interventional Mapping System (SIMS) algorithm developed to match a patient’s tumour biology to a specific drug combination.
Lung tissue biopsies obtained during the trial will be analysed using Illumina’s next generation sequencing (NGS) and HTG Molecular’s expression EdgeSeq technologies.