Pharmaceutical Market Europe • October 2024 • 8-9
NEWS
Sanofi has shared positive results from a late-stage study of its investigational BTK inhibitor, tolebrutinib, in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
The phase 3 HERCULES trial evaluated an oral dose of the candidate in MS patients who had stopped experiencing confirmed relapses but continued to experience accumulation of disability.
Results presented at this year’s European Committee for Treatment and Research in MS (ECTRIMS) conference showed that tolebrutinib delayed the time to onset of six-month confirmed disability progression by 31% compared to placebo.
Sanofi also reported that the number of patients who experienced confirmed disability improvement increased in the tolebrutinib arm, at 10% versus 5% in the placebo cohort.
Data from the phase 3 GEMINI 1 and 2 trials of the drug in relapsing MS was also shared at ECTRIMS.
The studies did not meet their shared primary endpoint of reducing annualised relapse rate compared to Sanofi’s current oral MS therapy Aubagio (teriflunomide), but a pooled analysis showed that tolebrutinib delayed the time to onset of six-month confirmed disability worsening by 29%.
AstraZeneca (AZ) has shared “unprecedented” overall survival (OS) results from a late-stage study of Imfinzi (durvalumab) plus Imjudo (tremelimumab) in advanced liver cancer.
The phase 3 HIMALAYA trial has been evaluating a single 300mg priming dose of Imjudo added to Imfinzi 1500mg, followed by Imfinzi every four weeks, in patients with unresectable, advanced hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment.
The results presented at this year’s European Society for Medical Oncology Congress showed that the combination, known as the STRIDE regimen, reduced the risk of death by 24% compared to sorafenib, a standard-of-care multi-kinase inhibitor, at five years of follow-up.
An estimated 19.6% of patients receiving Imfinzi plus Imjudo were alive at five years versus 9.4% of those in the sorafenib group. Additionally, in a subgroup analysis of patients who achieved disease control, 28.7% of those being treated with STRIDE were alive at five years compared to 12.7% of those in the sorafenib cohort.
The combination already holds approvals to treat adults with advanced or unresectable HCC in the US, EU and several other countries.
Merck & Co – known as MSD outside the US and Canada – and Daiichi Sankyo have announced that a late-stage trial of patritumab deruxtecan in non-small cell lung cancer (NSCLC) met its primary endpoint of progression-free survival (PFS).
The phase 3 HERTHENA-Lung02 study has been evaluating the HER3-directed antibody drug conjugate (ADC) in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR)-mutated NSCLC who have previously received EGFR tyrosine kinase inhibitor (TKI) treatment.
Results demonstrated a statistically significant improvement in PFS compared to a regimen of platinum plus pemetrexed induction chemotherapy followed by pemetrexed maintenance chemotherapy, the partners said, adding that the trial will continue to further assess overall survival.
NSCLC accounts for approximately 85% of all lung cancer cases, and EGFR-activating mutations occur in up to 38% of all NSCLC tumours globally.
Despite initial treatment with an EGFR TKI, many patients with metastatic EGFR-mutated NSCLC experience disease progression, and currently available therapies in the second-line setting are limited.
The companies began collaborating on patritumab deruxtecan last year after Merck paid Daiichi Sankyo $4bn upfront to jointly develop three of its ADC candidates.
Researchers from the Wellcome Sanger Institute have discovered that a common diabetes medication can slow the growth of precancerous cells in the oesophagus.
The findings published in Nature Genetics suggest that metformin could be used to manage squamous oesophageal cancer risk, and highlight the role of metabolic conditions in accelerating the growth of potentially cancerous cells.
The team, partly funded by Cancer Research UK, used experiments in mice, cell cultures and DNA sequencing of human samples to study the evolution of mutations in the oesophagus and focused on the PIK3CA gene, which plays a major role in cell growth and can cause cells to multiply rapidly when altered.
The researchers observed that cells with these PIK3CA mutations grow faster than normal cells, and that when treated with metformin, the mutant cells lost their growth advantage, both in mice and in lab-grown cells.
They also found that a high-fat diet and type 1 diabetes in mice enhanced the growth of cells with PIK3CA mutations, and human oesophagus sample analysis showed that overweight individuals had more cells with PIK3CA mutations compared to those at a normal weight.
Researchers from the Institute of Cancer Research (ICR) have found that prostate cancer patients with high levels of a specific protein have significantly poorer outcomes compared to those without.
The findings published in the Journal of Clinical Investigation suggest that BCL2, a protein responsible for preventing cell death, could be a new drug target for the disease and be used to help predict which patients will become resistant to hormone therapy.
The researchers estimate that around 10% of patients with the disease have high levels of BCL2.
The team examined 427 biopsies from 245 patients with metastatic castration-resistant prostate cancer and found that those with higher levels of BCL2 had a much shorter overall survival from the time of diagnosis of mCRPC, of 20.4 months versus 53 months.
A significant difference in response to common hormone therapy treatments, depending on the cancer’s level of BCL2, was also observed. Prostate-specific antigen levels were reduced by more than 50% in only 12.5% of patients with higher BCL2 levels, compared to 47.6% of those with lower BCL2 expression, and overall survival from starting therapy was markedly different.
The UK government has announced the launch of a joint public-private investment programme worth up to £400m to support clinical research and accelerate the development of new drugs.
It is hoped that the initiative, which is part of the Voluntary Scheme for Branded Medicine Pricing, Access and Growth, will give NHS patients earlier access to new treatments, strengthen clinical trials, as well as improve medicines manufacturing in the UK.
The programme will allocate 75% of the funding to expand the UK’s capacity for commercial clinical trials, with up to 18 new clinical trial hubs set to be opened across the four nations. Researchers will also have increased access to the latest equipment and technology to enable studies to be designed across hospital and primary, community and residential care settings.
Approximately 20% of the investment will be directed towards sustainable manufacturing initiatives, promoting efficiency and reducing waste and emissions within the pharmaceutical sector, while the remaining 5% will focus on modernising the Health Technology Assessment processes used to assess the cost and clinical effectiveness of new treatments.