The UK National Institute for Health and Care Excellence (NICE) has recommended Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) as a treatment option for certain resected oesophageal or gastro-oesophageal junction (GEJ) patients.

Opdivo has been cleared as an adjuvant treatment of completely resected oesophageal or GEJ cancer in adults who have residual disease following neoadjuvant chemoradiotherapy.

The recommendation was made based on clinical trial evidence showing that, for people who had residual disease after chemoradiotherapy and following surgery, Opdivo increases the time individuals’ live without their cancer returning compared to placebo.

In a statement, NICE added that Opdivo is likely to be more effective at extending how long people live overall, although the clinical trial evidence to demonstrate this is not yet available.

According to BMS, there are around 200 people in England who are eligible for this treatment. The company has also agreed a commercial agreement which makes Opdivo available to the NHS with a discount.

The main two types of oesophageal cancer are squamous cell carcinoma and adenocarcinoma – squamous cell carcinoma typically affects the upper and middle oesophagus, while adenocarcinoma usually affects the lower oesophagus, including the gastro-oesophageal junction.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally authorised Merck’s MET inhibitor Tepmetko (tepotinib) for the treatment of certain non-small cell lung cancer (NSCLC) patients.

The conditional marketing authorisation opens access to Tepmetko treatment for adult patients with advanced NSCLC harbouring mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping alterations.

The MHRA decision is based on results from the Phase II VISION study, evaluating Tepmetko monotherapy in patients with advanced or metastatic NSCLC with METex14 skipping alterations.

The efficacy of the therapy was evaluated among 146 patients, with the study demonstrating an objective response rate (ORR) by independent review of 45.2% in the combined-biopsy group.

The authorisation was conducted through Project ORBIS – a pathway coordinated by the US Food and Drug Administration (FDA).

The programme is designed to review and approve promising cancer treatments concurrently with regulatory authorities in six countries, including the UK’s MHRA.
It aims to speed-up patient access to innovative cancer treatments with potential benefits over existing therapies ‘across the globe’.

As such, further evidence on Tepmetko is awaited under the conditional marketing authorisation scheme.

AstraZeneca has announced positive results from a Phase III trial evaluating its long-acting antibody (LAAB) combination AZD7442 in non-hospitalised patients with mild-to-moderate symptomatic COVID-19.

In the Phase III TACKLE trial, a total of 90% of participants enrolled were from populations with a high-risk of progressing to severe COVID-19, including individuals with comorbidities.

The late-stage trial hit its primary endpoint, with AZD7442 600 mg given by intramuscular injections (IM) reducing the risk of developing severe COVID-19 or death from any cause by 50% compared to placebo in outpatients who had been symptomatic for seven days or less.

On top of that, a prespecified analysis of participants who received treatment within five days of symptom onset showed that AZD7442 reduced the risk of developing severe COVID-19 or death by 67% compared to placebo.

“These important results for AZD7442, our long-acting antibody combination, add to the growing body of evidence for use of this therapy in both prevention and treatment of COVID-19,” said Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AZ.

“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” he added.

AZ has already submitted a request to the FDA seeking an emergency use authorisation (EUA) for the LAAB combination for prophylaxis of COVID-19.

French pharma company Sanofi has revealed new long-term data for its investigational oral Bruton’s tyrosine kinase (BTK) inhibitor tolebrutinib, which demonstrated a ‘promising’ safety and efficacy profile in patients with relapsing forms of multiple sclerosis (MS).

Results from the Phase IIb long-term extension study (LTS) showed that after 48 weeks of treatment, Sanofi’s BTK inhibitor reduced multiple sclerosis (MS) disease activity – as measured by magnetic resonance imaging (MRI).

Sanofi also revealed data on the effect of tolebrutinib on human microglia, which the company says supports its capacity to modulate neuroinflammatory processes directly within the central nervous system (CNS). According to Sanofi, this data makes tolebrutinib the only BTK inhibitor in development for MS which has been shown to directly modulate microglia – based on ‘publicly available information’.

“Understanding the ability of a brain-penetrant therapy to slow disability accumulation has the potential to bring new hope to people suffering from difficult-to-treat MS,” said Erik Wallström, therapeutic area head, Neurology Development at Sanofi.

“For nearly two decades, Sanofi has been unwavering in its efforts to accelerate research and treatment options for these patients,” he added.

Currently, tolebrutinib is being evaluated in Phase III clinical trials for the treatment of RMS, non-relapsing secondary progressive MS (nrSPMS) and primary progressive MS (PPMS).