This week on Pipeline Moves, we start off by reviewing the terminations of a Phase II trial in oncology and Phase I/II trials in high-grade glioma and hepatocellular carcinoma. We also investigate a trial completion in osteoarthritis pain.

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Novartis Phase II oncology trial termination

Novartis’ Tabrecta (capmatinib hydrochloride) saw its Phase Transition Success Rate (PTSR) drop after a Phase II oncology trial was terminated. The PTSR decreased by 10 points to 45% in hepatocellular carcinoma. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

GlobalData evaluated the asset on 7 July after the entry was updated on the previous day.

GlobalData is the parent company of Clinical Trials Arena

The decision to terminate the Phase II trial (NCT01737827) was based on difficulties in identifying subjects who meet the eligibility criteria and therefore the study never reached its planned sample size per protocol. The trial termination was not due to any safety concerns.

The open-label, single-arm trial intended to evaluate the safety and efficacy of Tabrecta as first-line treatment in patients with advanced hepatocellular carcinoma. The trial recruited 38 patients before the termination.

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Tabrecta, also known as INC280, is a highly selective inhibitor of c-Met receptor tyrosine kinase (RTK). It was first marketed for non-small lung cancer in 2020.

Phase I/II high-grade glioma trial termination

Regeneron Pharmaceuticals’ Libtayo (cemiplimab) saw its PTSR fall after a Phase I/II trial in high-grade glioma was terminated. The PTSR decreased by 10 points to 11% in that indication.

GlobalData evaluated the asset on 11 July after the entry was updated on the previous day.

The decision to terminate the Phase I/II trial (NCT03690869) was determined by the sponsor and no further details were provided.

The purpose of the trial was to evaluate the safety and pharmacokinetics of Libtayo in paediatric patients with relapsed or refractory solid or central nervous system tumours, and the safety and efficacy in combination with radiotherapy in paediatric patients with newly diagnosed diffuse intrinsic pontine glioma, newly diagnosed high-grade glioma, or recurrent high-grade glioma. The trial recruited 57 out of the 150 patients originally anticipated to participate.

Libtayo works by inhibiting the activity of PD-1 receptor. The monoclonal antibody (mAb) is marketed and in development for the treatment of various cancers.

Phase I/II hepatocellular carcinoma trial termination

AVEO Oncology’s Fotivda (tivozanib hydrochloride) saw its PTSR decrease in metastatic hepatocellular carcinoma (HCC) after a Phase I/II trial was terminated. The drug’s PTSR dropped by 11 points to 9%.

The Phase I/II trial’s (NCT03970616) status was updated from completed to terminated on on 12 July, and GlobalData evaluated the asset the next day. According to the study’s listing, the study was terminated the study due to regulatory approval of newer therapeutic options and slower than anticipated accrual.

The study evaluated the safety and tolerability of Fotivda in combination with AstraZeneca’s Imfinzi (durvalumab) in subjects with advanced HCC. The study enrolled 27 out of the 42 patients originally anticipated to participate.

Fotivda is a highly potent protein kinase inhibitor and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2 and 3. The small molecule is marketed for the treatment of renal cell carcinoma and is under development for the treatment of various cancers.

Eli Lilly’s Phase II osteoarthritis pain trial completion

Eli Lilly’s LY-3857210 saw its PTSR rise in osteoarthritis pain after the completion of a Phase II trial. The PTSR grew by nine points to 38%.

The Phase II study (NCT05620563) evaluated the efficacy and safety of LY-3857210 in 147 patients with osteoarthritic pain. The trial’s status on was updated from active, not recruiting to completed on 12 July, and the PTSR change took effect the following day. It measured the change from baseline for average pain intensity measured through the Numeric Rating Scale (NRS) for up to eight weeks as the primary endpoint.

LY-3857210 is an oral P2X7 inhibitor. P2X7 is an ATP ligand-gated ion channel, which activates neuronal and non-neuronal cells in the peripheral and central nervous system pain pathways.

Read the last edition:

Pipeline Moves: Advancement prospects fall for Pfizer’s RSV therapy 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.