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OSE lung cancer vaccine clears phase 3 hurdle, but COVID-19 stalls programme

Tedopi is aimed at stimulating T-lymphocytes against tumours


OSE Immunotherapeutics has positive results from the first stage of its phase 3 trial of non-small cell lung cancer (NSCLC) vaccine Tedopi, but celebrations are on hold.

The French biotech says the coronavirus outbreak means the crucial second stage of the trial is now on hold for the time being, which could set the programme back by months.

On the plus side, Tedopi (OSE-2101) improved survival at one year compared to standard-of-care chemotherapy in patients with HLA-A2 positive NSCLC who had failed PD-1/PD-L1 inhibitor therapy, achieving the Atalante 1 trial’s primary objective.

At 12 months, 46% of patients treated with the vaccine were still alive, compared to 36% of the chemotherapy group. OSE had designed the first part of the trial with the proviso that a survival rate above 40% would be considered a successful outcome.

A second, larger stage should now start to see if that initial efficacy readout will translate to an improvement in overall survival, but for now that has been shelved.

“There is ongoing concern that trial data may be markedly impacted given the current worldwide COVID19 pandemic and the increased risk for patients with NSCLC, as COVID-19 can cause serious pulmonary complications in this immunocompromised patient population,” said OSE.

“Recommendations from several medical societies include voluntary holds on recruitment of new patients in oncology trials for the time being, due to patient safety concerns,” it added.

It’s a disappointment for OSE, which is vying to become the first to bring a drug for HLA-A2 positive NSCLC to market. It’s estimated almost half of all NSCLC cases carry the HLA-A2 antigen so could benefit from a drug that can induce an immune response to the biomarker.

Tedopi is a combination of 10 neoantigens – markers found on malignant cells but not healthy cells – aimed at stimulating T-lymphocytes against tumours.

OSE is also running a phase 2 study of Tedopi in HLA-A2 positive pancreatic cancer patients in combination with Bristol Myers-Squibb's PD-1 checkpoint inhibitor Opdivo (nivolumab), but the company didn’t indicate whether that trial was also affected by COVID-19.

The trial is testing Tedopi as a maintenance therapy, alone or in combination with Opdivo, compared to a standard chemotherapy regimen of folinic acid, 5-fluorouracil, irinotecan and oxaliplatin.

OSE’s chief executive Alexis Peyroles remains upbeat on the vaccine despite the delay, and said efforts to find a partner for the programme will be stepped up.

“Based on these positive results, we are now eager to engage in discussions with regulatory authorities to evaluate Tedopi’s current clinical results and agree upon the best options for further development,” he added.

Article by
Phil Taylor

2nd April 2020

From: Research



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