Update for February 15, 2022

Regulatory Update

An FDA review of sintilimab agreed with the editorial by Singha and Pazdura. The review questions whether the data from a single country is representative of the U.S. population and if use of progression-free survival instead of overall survival (OS) is acceptable. They point out that OS is a stronger endpoint and has been used for other checkpoint inhibitors that have received approval. The FDA's Oncologic Drugs Advisory Committee agreed with the FDA’s review and rejected the BLA for sintilimab plus pemetrexed and platinum-based chemotherapy for the treatment of nonsquamous non–small cell lung cancer and recommended a new clinical trial be conducted.
 
Announced Research Updates
 
Alzhon announced interim data after 26-weeks from 80 patents enrolled in an 84 patient, open-label, Phase II trial, where treatment with valiltramiprosate resulted in a 29% reduction in plasma p-tau181 and an improvement in the Rey Auditory Verbal Learning Test (RAVLT) in patients with early Alzheimer’s disease who carry the APOE4/4 or APOE3/4 genotype.
 
Phathom announced that in the 42-day, 458 patient, Phase II PHALCON-NERD trial, relief of a heartburn episode was achieved within three hours with no further symptoms for 24-hours in 56% of patients treated with vonoprazan 10 mg, 60.6% with 20 mg and 70% with 40 mg compared to 27.3% with placebo in patients with non-erosive gastroesophageal reflux disease (NERD).
 
ProQR announced that in the 12-month, 36 patient, Phase II/III, ILLUMINATE trial, treatment with sepofarsen did not improve BCVA compared to sham injection in patients with Leber’s Congenital Amaurosis 10 due to the p.Cys998X mutation in the CEP290 gene.
 
AZ announced that in the 1,171, open-label, Phase III HIMALAYA trial, patients treated with tremelimumab plus durvalumab achieved an objective repose rate of 20% compared to 17% with durvalumab and 5% with sorafenib in patients with hepatocellular carcinoma.
 
Published Research Updates
 
In the 40-week, 475 patient, Phase III SURPASS-5 trial, treatment with tirzepatide reduced HbA1C by 2.11% with 5 mg, 2.40% with 10 mg and 2.34% with 15 mg compared to a 0.86% decrease with placebo in patients with type 2 diabetes inadequately controlled with insulin glargine with or without metformin. Tirzepatide also decreased body weight more than semaglutide by 5.4 kg with 5 mg, 7.5 kg with 10 mg and 8.8 kg with 15 mg compared to a 1.6 kg decrease with placebo.
 
In a 6-week, 150 patient, Phase III trial, the PANSS score was decreased by 20.5 with blonanserin 16 mg compared to a 10.6 point decrease with placebo in Japanese patients, 12-18 years of age, with schizophrenia. Blonanserin 8 mg did not provide an improvement compared to placebo.
 
In a 24-week, 321 patient, Phase III trial, treatment with balovaptan did not improve the Vineland-II 2DC score compared to placebo in autistic adult patients.
 
Check out our new lower subscription rates and don't miss out on these clinical updates