Valneva – a company specialising in vaccines – has completed enrolment for a phase 3 trial of its single-shot chikungunya vaccine candidate, VLA1553. The group is comprised of adolescents and initial results of the study are expected halfway through this year.

Conducted in partnership with Instituto Butantan, VLA1553-321 is a multi-centre, double-blinded, randomised and placebo-controlled phase 3 trial. In total, 754 adolescents aged 12 to 17 years were vaccinated following randomisation at a 2:1 ratio to receive either VLA1553 or the placebo.

The central target of the trial is to evaluate immunogenicity and safety 28 days after a single vaccination with VLA1553. Participants will then be evaluated for the primary endpoint and monitored for up to 12 months.

The company completed submission of the Biologics License Application (BLA) to the US Food and Drug Administration for approval of VLA1553 in individuals of 18 years and above in December 2022. If approved it could become the first chikungunya vaccine to be marketed in the US.

Valneva reported final pivotal phase 3 data for VLA1553 in March last year and final results in May. Furthermore, the company also recently reported positive antibody persistence data with a 99% seroresponse rate 12 months after the single-dose vaccination.

The research is funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and aims to support the label extension in this age group following the initial regulatory approval.

Ultimately, the adolescent trial is expected to yield licences for the vaccine in Europe and Brazil, which would be the first potential approval for use in endemic populations.

Ipsen has revealed follow-up results from its phase 3 CheckMate-9ER trial. The study demonstrated that Cabometyx in combination with nivolumab provides survival benefits after three-years of treating advanced renal cell carcinoma (RCC), compared to sunitinib.

During the CheckMate-9ER trial, overall survival benefits were maintained during three-years of follow-up. Meanwhile, median overall survival was significantly higher for patients on Cabometyx (also known as cabozantinib) together with nivolumab versus sunitinib.

Accounting for around 90% of cases, RCC is the most common type of kidney cancer. When detected at an early stage, the five-year survival rate is high, but for people living with advanced or late-stage metastatic RCC the survival rate is considerably lower – around 12%.

The study results were also assessed by the following International Metastatic Renal Cell Carcinoma Database Consortium risk scores. Benefits were duly identified with Cabometyx in combination with nivolumab across all efficacy measures, regardless of IMDC risk.

Steven Hildemann, executive vice president at Ipsen, explained: “The results from the CheckMate-9ER study continue to demonstrate sustained, now three-year long-term benefits for people living with advanced renal cell carcinoma across the most meaningful efficacy measures and risk scores, adding to the body of evidence we have for Cabometyx plus nivolumab. We sincerely thank the patients who participated in the trial, their families and their healthcare teams.”

Mauricio Burotto, medical director at Bradford Hill Clinical Research Center, added: “Despite the progress made through science and medicine, there remains a need for treatment options that can durably extend survival for patients with metastatic renal cell carcinoma, especially for those classified as higher risk.”