This week in clinical trials: 22nd to 26th January 2024
And so, our weekly clinical trials round-ups continue. In this instalment, we look at developments in life sciences research and development announced during the week of 22nd to 26th January, from early-stage onwards. During that week, there were only a couple of developments that caught our eye - in the fields of ophthalmology (absolutely no pun intended) and oncology – but they are yet worthy of attention.
- Bayer receives MHRA authorisation for aflibercept 8mg for wet age-related macular degeneration.
- BioNTech and Duality Bio announce first patient with metastatic breast cancer treated in Ph3 trial of ADC candidate BNT323/DB-1303 targeting HER2.
During the week of 22nd to 26th January:
Bayer announced it had received Medicines and Healthcare products Regulatory Agency (MHRA) authorisation for aflibercept 8 mg (EYLEA® 8mg) in adults in the UK for the treatment of neovascular (wet) age-related macular degeneration (nAMD), and visual impairment due to diabetic macular oedema (DMO).
The authorisation is based on positive data from Phase 3 study PULSAR in nAMD and Phase 2/3 study PHOTON in DMO, which compared aflibercept 8 mg with a lower 2 mg dose in patients with nAMD and DMO, respectively. At week 48, both studies met their primary endpoint of non-inferiority in terms of best corrected visual acuity (BCVA) of aflibercept 8 mg with two extended dosing regimens (every 12 and 16 weeks) compared to aflibercept 2 mg dosed every eight weeks, following initial monthly doses.
nAMD is a chronic progressive eye disease, predominantly affecting older people and is a major cause of blindness worldwide. DMO is also characterised by loss of central vision and is the most common cause of sight loss in people with Type 2 diabetes. Treatment generally consists of regular injections into the eye.
According to NHS England, ophthalmology is currently the busiest outpatient speciality in secondary care and comprises nearly 10% of the entire NHS waiting list.
Cathy Yelf, chief executive of the Macular Society, commented, “Having a new treatment that both increases options and the time between hospital visits will improve the lives of patients and benefit the NHS.”
Aflibercept 8 mg is expected to be available from early February to NHS patients.
BioNTech and Duality Bio have announced that the first patient has been treated in their Phase 3 trial evaluating the efficacy and safety of the next-generation antibody-drug conjugate (ADC) candidate BNT323/DB-1303 in metastatic breast cancer, targeting cancer cell surface protein Human Epidermal Growth Factor Receptor 2 (HER2).
The global, multi-centre, open-label, randomised Phase 3 trial with the third-generation topoisomerase-1 inhibitor-based ADC BNT323/DB-1303 follows positive Phase 1/2 safety and efficacy data in patients with HER2-expressing advanced solid tumours with early signs of anti-tumour activity in heavily pretreated patients with HER2-low and HER2-positive breast cancer.
The trial is expected to enrol 532 patients with Hormone Receptor-positive (HR+) and HER2-low metastatic breast cancer progressing on hormone therapy at clinical trial sites worldwide, though initially in China, followed by sites in the US, Europe, and additional regions.
Breast cancer is the most commonly diagnosed cancer worldwide and the leading cause of death from malignant tumours in women globally. The clinical milestone is in furtherance of BioNTech’s and Duality Bio’s strategic objective to advance BNT323/DB-1303 into late-stage development in multiple high unmet medical need cancer indications.
Data presented at ASCO 2023 demonstrated encouraging anti-tumour activity in heavily pretreated patients with HER2-low breast cancer with an objective response rate of 38.5% and a disease control rate of 84.6%.
BioNTech will hold commercial rights globally (excluding Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region), while Duality Bio will retain commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.