September 2023 • PharmaTimes Magazine • 9
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Taiho begins latest non-small cell lung cancer trial
Taiho Oncology has announced the launch of its phase 3 REZILIENT3 study to evaluate zipalertinib, combined with chemotherapy, as a first-line treatment among adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation.
The randomised, multi-location, open-label, global trial is currently enrolling adults and aims to analyse progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm. Ultimately, around 312 global patients will be recruited to participate.
The launch of the trial follows the phase 1/2a stages of the zipalertinib trial, during which results showed the therapeutic potential of the drug in heavily pretreated patients. Updated data from this study was recently published in the Journal of Clinical Oncology.
Jeffrey Jones, chief medical officer at Cullinan Oncology, was optimistic about the latest trial: “The initiation of the phase 3 trial for zipalertinib in the first-line setting is an important step forward for this clinical research programme, as it represents an opportunity for zipalertinib to help more patients with EGFR exon 20 insertion mutation NSCLC.”
He added: “We look forward to working with our partners at Taiho to rapidly assess zipalertinib in the front-line, while in parallel continuing to advance our pivotal phase 2b trial in patients who have received prior systemic treatment for locally advanced or metastatic disease.”
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HOT & NOT
Infex Therapeutics, a company focusing on anti-infectives, has revealed the nomination of a candidate for its COV-X programme.
The candidate for COV-X – Infex’s novel first-in-class small molecule oral pan-coronavirus PLPRO inhibitor – was chosen after in vivo efficacy data emerged in a murine SARS-CoV-2 model that showed an almost complete decrease in SARS-CoV-2 viral load in the lungs.
Meanwhile, it also delivered a sound safety profile when compared to nirmatrelvir, Pfizer’s approved MPRO inhibitor.
Chiesi has announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for Elfabrio across Britain.
Also known as pegunigalsidase alfa, the treatment involves long-term enzyme replacement therapy among adult patients with a confirmed diagnosis of Fabry disease.
Pegunigalsidase alfa is produced in plant cells using recombinant DNA technology and the treatment remains the only PEGylated ERT for Fabry disease.
CervoMed – a company focusing on treatments for degenerative brain conditions – has announced that it has finalised its merger with EIP Pharma.
The united company will still be known as CervoMed, and the merged business will concentrate on advancing lead drug candidate neflamapimod.
The therapy is anoral stress kinase inhibitor, which is currently being developed for the treatment of dementia with Lewy bodies and various other degenerative brain diseases.
CNX Therapeutics – a company focusing on boosting medicine access – has announced that it has acquired four cancer support products from Clinigen.
The four therapies concerned are Cardioxane (also known as dexrazoxane), Totect (also known as dexrazoxane), Ethyol (also known as amifostine) and Savene (also known as dexrazoxane).
All of the treatments help alleviate the sideeffects that individuals may experience when treated with other cancer drugs.
The National Institute for Health and Care Excellence (NICE) has issued a draft appraisal consultation document, which does not recommend CSL Behring’s gene therapy treatment Hemgenix.
The company is disappointed with NICE's draft decision, as results from its phase 3 HOPE-B trial demonstrated that after a single infusion of etranacogene dezaparvovec, 96% of patients discontinued routine FIX prophylaxis.
This effectively meant that they no longer required regular infusions – for up to two years – to help their blood clot.
A report from the Office for National Statistics has revealed that people in Britain feel their general well-being has declined in recent years. As the NHS commemorates its 75th anniversary, the survey reveals only half of us are happy with the UK’s healthcare system and the percentage of UK adults who are mostly or completely satisfied with their health has declined 8.6% since the first such poll in 2010. Dr Avinash Hari Narayanan, from the London Medical Laboratory, added that there has also been a 5.9% increase since 2016 in the number of people reporting depression.