This week on Pipeline Moves, we kickoff by looking at the completion of a Phase III trial in oesophageal cancer. On a good note, we investigate the completion of a Phase IIb trial in congestive heart failure and chronic kidney disease, a Phase II trial in triple-negative breast cancer, a Phase I trial in metastatic colorectal cancer and a Phase I trial in paediatric diffuse intrinsic pontine glioma.
Phase III trial Completion
Innovent Biologics’ sintilimab saw a six-point jump in its Likelihood of Approval (LoA), reaching 67% following a Phase III completion. LoA is identified via GlobalData’s analysis using a combination of machine learning and a proprietary algorithm.
The Phase III study’s (NCT03748134) status on ClinicalTrials.gov was changed from recruiting to completed on 24 October. GlobalData evaluated the asset on 25 October. The purpose of the multicentre, double-blind, randomised trial, called ORIENT-15, was to determine the efficacy and safety of sintilimab or placebo in combination with chemotherapy as a first-line treatment in subjects with unresectable, locally advanced recurrent or metastatic oesophageal squamous cell carcinoma. The trial enrolled a total of 746 participants.
Sintilimab works by antagonising programmed cell death protein-1 (PD1). The drug is marketed under the brand name Tyvyt in China. Upon binding, sintilimab blocks PD1 activity and evokes an anti-tumour response.
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AstraZeneca’s Phase IIb trial completion
AstraZeneca’s balcinrenone saw its Phase Transition Success Rate (PTSR) grow in congestive heart failure and chronic kidney disease after the completion of a Phase IIb study.
The compound’s PTSR grew by nine points to 42% in both indications. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The trial’s status (NCT04595370) was updated from active, not recruiting to completed on ClinicalTrials.gov on 24 October, and GlobalData updated the PTSR a day later. The study evaluated the efficacy and safety of balcinrenone in combination with dapagliflozin compared with dapagliflozin alone.
The 153-subject trial studied the percentage change in the urinary albumin to creatinine ratio from baseline until week 12 as the primary endpoint. Also known as AZD9977, balcinrenone is a mineralocorticoid receptor (MR) antagonist.
Completion of Phase II trial
I-Mab’s uliledlimab (TJ004309) saw a six-point increase in its PTSR, settling at 38% in triple-negative breast cancer (TNBC).
The Phase II study’s Clinicaltrials.gov (NCT05001347) status changed from active, not recruiting to completed on 10 October, and GlobalData evaluated the asset on 13 October following a Phase II trial completion. The trial investigated the safety and efficacy of uliledlimab in combination with atezolizumab for patients with advanced or metastatic solid tumours.
Uliledlimab acts by inhibiting CD73, which is expressed on regulatory T cells and tumour cells. This leads to increased immunosuppression through the pathway degrading ATP into adenosine, which increases anti-tumour activity. I-Mab is developing the treatment for several cancers including non-small cell lung cancer, gastric cancer and laryngeal cancer.
Phase I trial completion
Arrys Therapeutics’ grapiprant saw its PTSR increase in metastatic colorectal cancer after a Phase I trial was completed. The drug’s PTSR grew by 11 points to 75%.
The Phase I trial’s (NCT03658772) status was updated from recruiting to completed on ClinicalTrials.gov on 24 October, and GlobalData evaluated the asset on the following day. The purpose of this multi-centre, open-label study was to assess the safety and tolerability of grapiprant in combination with Merck’s Keytruda (pembrolizumab). The trial enrolled 54 patients.
Grapiprant is an EP4 antagonist. The drug candidate inhibits IL-23 production from dendritic cells and suppresses the expansion of Th17 cells, contributing to the pathogenesis of autoimmune diseases and cancers. The drug candidate is under development for the treatment of various cancers, allergies and autoimmune disorders.
Eli Lilly’s Phase I trial completion
Eli Lilly’s Verzenio (abemaciclib) saw its PTSR increase in paediatric diffuse intrinsic pontine glioma (DIPG) after a Phase I trial in DIPG and recurrent and refractory solid tumours was completed. The drug’s PTSR increased by seven points, reaching 73% in DIPG. The trial was sponsored by Emory University, which is based in Georgia, US.
The Phase I trial’s (NCT02644460) status was updated from recruiting to completed on ClinicalTrials.gov on 26 October, and GlobalData evaluated the asset on the next day.
The open-label study evaluated the safety and pharmacokinetics of LY2835219 in children and young adults with newly diagnosed DIPG and in relapsed, refractory, progressive malignant brain and solid tumour patients. The study’s co-primary endpoints assessed the maximum tolerated dose (MTD) for DIPG and for recurrent /refractory solid tumours within a time frame of up to six weeks, in addition to other pharmacokinetic and pharmacodynamic measures.
Verzenio is a CDK 4/6 inhibitor marketed to treat for hormone-sensitive breast cancer, metastatic breast cancer, human epidermal growth factor receptor 2 (HER2)-negative breast cancer in different settings.
Read the last edition:Pipeline Moves: Advancement prospects drop for hearing loss drug after trial termination
Need to know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.