Strong survival data backs Sanofi’s early finish for Phase 3 lung cancer clinical trial
Sanofi and Regeneron have pumped the breaks on their Phase 3 clinical trial for a Libtayo-chemotherapy combo in lung cancer because the treatment already proved to increase the overall survival rate of patients with first-line advanced non-small cell lung cancer (NSCLC).
Lung cancer is the leading cause of cancer death worldwide. In 2020, an estimated 2.2 million new cases of lung cancer were diagnosed globally. Approximately 84 per cent of all lung cancers are NSCLC, with 75 per cent of cases diagnosed in advanced stages, according to Sanofi.
After winning the US Food and Drug Administration nod for the completion of their Phase 2 clinical trial in just two weeks in February 2021, the Sanofi-Regeneron lung cancer treatment rivalled Merck’s skin cancer treatment, Keytruda, for the blockbuster favorite, Fierce Pharma reported.
The decision to stop the Phase 3 trial of Libtayo early was based on a recommendation by the Independent Data Monitoring Committee during a protocol-specified interim analysis.
Miranda Gogishvili, an oncologist at the High Technology Medical Center, University Clinic, in Tbilisi, Georgia and a trial investigator, said: “Libtayo in combination with chemotherapy increased median overall survival to 22 months in patients with advanced non-small cell lung cancer, compared to 13 months with chemotherapy alone.”
This means, in this top-line initial analysis of 466 patients, that combining Libtayo with chemotherapy reduced the risk of death by 29 per cent compared to chemotherapy alone.
Gogishvili added: “Notably, the Phase 3 trial enrolled patients with a variety of challenging-to-treat disease characteristics, as well as those with locally advanced disease. This data adds to the growing body of evidence supporting Libtayo in advanced non-small cell lung cancer, which also includes the pivotal results for Libtayo monotherapy in cases of high PD-L1 expression.”
The data of the Sanofi-Regeneron Phase 3 clinical trial is planned to form the basis of regulatory submission for lung cancer trials in the US and EU, according to Sanofi.
Bayer commits to farmer-centric innovation portfolio to advance food and health security
Bayer has set its eyes on expanding its innovation portfolio, once solely focused on pharmaceuticals, to include scientific investigation into chemicals used in farming and agriculture.
Bayer has claimed that focus on famer-centric solutions is vital in broadening its product portfolio, at a time when new tools in scientific innovation is ever more important for combatting the Covid-19 pandemic health crisis and its implications on food and nutritional security.
Current food consumption patterns are a leading cause of morbidity and disability according to a report by the World Health Organization, with poor diets accounting for 8 million premature deaths globally every year. This requires increased spending for healthcare organizations to treat patients with malnutrition and places significant burdens on national healthcare systems and economies.
With an aim to improve global food and health security Bayer is investigating the chemical diflufenican to advance framing, crop protection and scientific chemical discovery.
Frank Rittemann, Product Manager at Bayer, said: “We are taking a look at chemistries [diflufenican, chief among them] that control some of farmers’ most challenging pests and we are relying on science to bring those options to the market, including previously untapped sites of action.”
“While there may be no proverbial silver bullets, our crop protection focus will provide continuous advances in healthcare by adding additional tools where farmers need it most,” Rittemann added.
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