GSK’s Marketing Authorisation Application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted by the European Medicines Agency (EMA) under accelerated assessment, with a decision expected in the third quarter of 2023.

There is currently no US-approved vaccine for RSV, a contagious virus characterised by several cold-like symptoms. Although most people recover within a week or two, the virus can be dangerous, especially for children and older adults, according to the Centers for Disease Control and Prevention.

The submission is based on positive data from a pre-specified interim analysis of the pivotal AReSVi-006 phase 3 trial, which demonstrated overall vaccine efficacy of 82.6% against RSV lower respiratory tract disease (LRTD) in adults aged 60 years and older.

Consistent high vaccine efficacy was also observed across a range of pre-specified secondary endpoints, while the vaccine was well tolerated with a favourable safety profile, the company reported.

Efficacy was 94.1% against severe RSV-LRTD, defined as LRTD with at least two lower respiratory signs or assessed as severe by the investigator and confirmed by the external adjudication committee. In participants with pre-existing comorbidities, such as underlying cardiorespiratory and endocrine metabolic conditions, vaccine efficacy was 94.6%, with 93.8% efficacy observed in adults aged 70 to 79 years.

Regeneron’s PD-1 inhibitor Libtayo (cemiplimab-rwlc) has been approved by the US Food and Drug Administration (FDA), in combination with platinum-based chemotherapy, as a first-line treatment for adults with advanced non-small cell lung cancer (NSCLC).

Specifically, the treatment is indicated for patients with no epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) or ROS1 aberrations, and those eligible for treatment will either have metastatic or locally advanced tumours that are not candidates for surgical resection or definitive chemoradiation, the company specified in a statement.

The approval is based on positive results from the global phase 3 trial, EMPOWER-Lung 3, that investigated Libtayo in combination with platinum-doublet chemotherapy, compared to platinum-doublet chemotherapy alone.

During the trial, 466 patients were randomised and given either Libtayo 350mg or placebo intravenously every three weeks, plus platinum-doublet chemotherapy.

The study showed patients receiving the combination therapy achieved a 22-month overall survival, versus 13 months for those receiving chemotherapy alone. This significant improvement in overall survival, which was the primary endpoint of the trial, was the basis for the Independent Data Monitoring Committee’s recommendation that the trial be stopped early.

Lung cancer is the leading cause of cancer-related deaths worldwide. Approximately 84% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages.

Ipsen’s cabozantinib has been recommended by the National Institute for Health and Care Excellence (NICE) as an option for patients with previously treated advanced hepatocellular carcinoma (HCC).

Specifically, the recommendation is for adults who have had sorafenib – the standard initial treatment for advanced disease – only if they have Child-Pugh grade A liver impairment and an Eastern Cooperative Oncology Group performance status of zero or one.

NICE’s decision is based on positive results from the global placebo-controlled CELESTIAL phase 3 pivotal trial in patients in the second or third line after treatment with sorafenib.

The trial met its primary endpoint of overall survival (OS), with cabozantinib providing a statistically significant improvement in OS compared with placebo in patients with advanced HCC who have been previously treated with sorafenib.

The median OS in the overall population was 10.2 months with cabozantinib and eight months with placebo. A longer duration of progression-free survival (PFS) was also observed, with a PFS of 5.2 months in cabozantinib-treated patients and 1.9 months in those receiving placebo.

Adverse reactions were consistent with the known safety profile of cabozantinib, and the number of high-grade adverse reactions in the cabozantinib group was approximately twice as many as there were in the placebo group.

The US Food and Drug Administration (FDA) has given accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) to treat adults with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Most patients present with late-stage disease and will typically undergo surgery, followed by platinum-based chemotherapy, but the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies have low response rates, short durations of response and significant toxicities.

The FDA’s decision was based on positive results from the pivotal SORAYA trial, a single-arm study of 106 patients with platinum-resistant ovarian cancer whose tumours expressed high levels of FRα and who had been treated with one to three prior systemic treatment regimens, at least one of which included Avastin (bevacizumab).

Elahere demonstrated an overall response rate – the primary endpoint of the study – of 31.7%, including five complete responses. The average duration of response – the key secondary endpoint – was 6.9 months.

The company outlined that the safety of Elahere has been evaluated in a pooled analysis from three studies among a total of 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least one dose of Elahere.