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August 23, 2022

Pipeline Moves: Lilly completes pain, cancer trials, advancement prospects rise

The Clinical Trials Arena team also investigates a trial suspension in solid tumours and a trial completion in neuroendocrine tumours.

By Clinical Trials Arena Team

This week on Pipeline Moves, we start with two trial completions from Eli Lilly: a Phase II in osteoarthritis pain and a Phase I in transitional cell carcinoma. We round out the week with a Phase I trial suspension in solid tumours and a Phase I completion in neuroendocrine tumours.

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Lilly completes Phase II in osteoarthritis pain

Eli Lilly’s LY-3526318 saw its Phase Transition Success Rate (PTSR) jump ten points to 38% in osteoarthritis-related pain after a Phase II trial completion. ClinicalTrials.gov updated the study’s status from “Active, not recruiting” to “Completed” on August 11, and the PTSR change took effect the next day. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase II study (NCT05080660) had an original target enrollment of 150 patients with osteoarthritis, but 160 patients were enrolled, as per the trial listing. As a primary endpoint, the study used the Numeric Rating Scale (NRS) for pain intensity, which entails patients rating their pain on a scale of 1-10.

LY-3526318 acts by blocking transient receptor potential cation channel subfamily A member 1 (TRPA1), thereby suppressing pain impulse transition. The Phase II trial was part of the Chronic Pain Master Protocol (CPMP) designed to accelerate the development of chronic pain drug candidates.

Lilly finishes Phase I in transitional cell carcinoma

Eli Lilly’s Cyramza (ramucirumab) saw its PTSR rise in transitional cell carcinoma, also referred to as urothelial cell carcinoma, after the completion of a Phase I oncology study. The PSTR increased by seven points reaching 74% in transitional cell carcinoma.

The Phase I trial’s status was marked as “Completed” on its ClinicalTrials.gov listing on August 11, with GlobalData evaluating the asset the next day. The study aimed to recruit 155 participants but eventually recruited 298 subjects.

The Phase I trial (NCT02443324) investigated Cyramza combined with Merck’s Keytruda (pembrolizumab) in participants with metastatic disease or locally advanced, unresectable adenocarcinoma of the gastroesophageal junction, biliary tract cancer, gastric adenocarcinoma, non-small cell lung cancer, or transitional cell carcinoma. The trial has a primary endpoint looking at dose-limiting toxicities, with a variety of secondary efficacy endpoints.

Monoclonal antibody Cyramza is a Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) antagonist. Cyramza was first approved by the FDA for gastric cancer and non-small cell lung cancer in 2014, with subsequent approvals in metastatic colorectal cancer and hepatocellular carcinoma.

Phase I solid tumour trial suspension

Pact Pharma’s NeoTCR-P1 (Neoantigen Targeted TCR T-cell therapy) saw its PTSR decline in eight oncology indications after a Phase Ia/Ib study in solid tumors was suspended. The reason for the suspension was listed as a “business decision”, on the ClinicalTrials.gov listing. The trial’s status was marked as “Suspended” on ClinicalTrials.gov on August 18, with GlobalData evaluating the asset on the next day.

The largest PTSR change was a 36-point drop to 28% for head and neck cancer. The PTSR also decreased by 35 points for both lung cancer and bladder cancer, settling at 29%. It also declined by 34 points for transitional cell cancer (now 31%), metastatic colorectal cancer (now 31%), and metastatic ovarian cancer (now 30%). Lastly, the PTSR dropped by 33 points for metastatic breast cancer and metastatic ovarian cancer to 32% for both indications

The open-label Phase Ia/Ib study (NCT03970382) investigated the safety and efficacy of a single dose of NeoTCR-P1 T cells (with or without an anti-PD-1 agent) in patients with incurable or metastatic solid tumors. The study initially aimed to enroll 140 participants but ended up recruiting only 21 subjects.

NeoTCR-P1 comprises of autologous, gene-edited tumor infiltrating lymphocytes (TILs) developed by the imPACT Isolation Technology platform. The TILs are infused back into the patient enabling the destruction of tumor cells conferring specific antigens and improving immune response.

Neuroendocrine tumour Phase I completes

HEC Pharma’s HEC-68498 saw its PTSR in neuroendocrine tumors grow by six points to 62% after the completion of a Phase I study. The study was sponsored by Sunshine Lake Pharma. HEC Pharma is a subsidiary of the HEC Pharm Group, which also owns Sunshine Lake Pharma.

The study’s ClinicalTrials.gov page updated the Phase I trial’s status from “Active, not recruiting” to “Completed” on August 12. GlobalData appraised the asset on August 16.

The open-label study (NCT04324372) evaluated the maximum tolerated dose and dose limiting toxicity of the treatment in subjects with advanced refractory solid tumors. The study was anticipated to enrol 72 participants but ended with 12.

The trial looked at the maximum tolerated dose over a 28-day timeframe as the primary endpoint. HEC-68498 inhibits phosphatidylinositol 3 kinase (PI3K) and the mechanistic target of rapamycin (mTOR). 

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 data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.

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