Clinical Trial Updates
What are clinical trials? They are a type of research that test for treatments to give to people. They must go through various stages and pass certain criteria before being available to the general public. Drugs will be tested on tissues, healthy volunteers and patients at individual stages, and placebos will be distributed. It takes years and years of research for a drug to be approved and considered safe for use, many drugs will not reach phase 4 (the final stage.) Drugs may be compared to existing drugs to test for significant improvements.
Terlipressin has a similar structure to vasopressin (ADH), a hormone we naturally produce. Terlipressin is therefore an analogue drug used to manage blood pressure. Terlipressin has hit a phase 3 endpoint in clinical trials. In evaluation of the drug, the efficacy and safety was tested on 300 patients with hepatorenal syndrome type 1 (HRS-1).
“The initial results from the Phase III COFIRM study are very encouraging in that they demonstrate terlipressin reversed the course of HRS-1 as measured by improvement in renal function, avoidance of dialysis and short-term survival. The study met nearly all of the pre-specified secondary endpoints.”- says Arun Sanyal.
Lynparza (olaparib) is a joint company drug by AstraZeneca and MSD that has met the primary endpoint in a phase III clinical trial for prostate cancer. Prostate cancer being the second-most common cancer in males is associated with a significantly high mortality rate. Lynparza shows significant improvement, both statistically and clinically, in survival without the use of radiation. The drug is currently approved in 64 countries and is available to adults who have: advanced ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
NICE (National Institute for Health and Care Excellence) has recommended MSD’s Keytruda (pembrolizumab). Keytruda is a medicine used to treat melanoma, a skin cancer. The drug works by working with your immune system, causing your immune system to attack normal organs or tissues all over the body. In clinical trials, the drug was seen to significantly improve survival rates.
“The addition of pembrolizumab significantly improves overall survival compared to chemotherapy alone and, importantly, across all strata of tumour cell PD-L1 expression. The combination of pembrolizumab and chemotherapy in eligible patients with advanced squamous non-small cell lung cancer should now become the first line standard of care and the benchmark for future first line studies in the disease.”- says Professor Gary Middleton from the University of Birmingham.
Rozlytrek has been FDA approved for treating ROS1-positive metastatic non-small cell lung cancer. This is following success in clinical trials, where Rozlytrek shrank 78% of patient tumours.
“Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”- says Sandra Horning from Roche.