BMS immunotherapy slips after lung cancer trial halted: regulatory roundup
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Regulatory roundup: BMS’s T lymphocyte immunotherapy tripped by lung cancer trial termination

By Reynald Castaneda 20 Sep 2021 (Last Updated September 20th, 2021 14:13)

Sanofi’s pemphigus asset, Artios solid tumor trial among recent events reviewed by GlobalData’s Investigative News team.

Regulatory roundup: BMS’s T lymphocyte immunotherapy tripped by lung cancer trial termination
BMS T lymphocyte immunotherapy JTCR016 saw its PTSR plummet by 24 points to 21% after the termination of an investigator-led Phase I/II trial in non-small cell lung cancer (NSCLC) or mesothelioma. Credit: nitpicker / Shutterstock.com

Need to Know:

GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s Phase Transition Success Rate (PTSR) and Likelihood of Approval (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.

BMS immunotherapy drops 24 points

Bristol Myers Squibb’s T lymphocyte immunotherapy JTCR016 saw its PTSR plummet by 24 points to 21% after the termination of an investigator-led Phase I/II trial in non-small cell lung cancer (NSCLC) or mesothelioma.

The decision to terminate the 11-patient Phase I/II was due to loss of funding, as noted by a 16 August update on ClinicalTrials.gov. The PTSR change went live on 13 September. The trial involves T cells being collected from patients. The T cells are then modified to target tumour cells with the Wilms’ tumour 1 (WT1) protein. The Phase I/II has coprimary endpoints investigating safety and T cell-related efficacy measures.

The Phase I/II termination resulted in a 7-point drop in JTCR016’s LoA to 7%. Public information shows JTCR016 is under Juno Therapeutics, but was acquired by Celgene in January 2018, which was then acquired by BMS in November 2019. The BMS immunotherapy is also under development for acute myelocytic leukemia (AML) and chronic myelogenous leukemia (CML).

Sanofi approval chances dive in pemphigus

Sanofi’s rilzabrutinib saw its LoA plummet in moderate-to-severe pemphigus after it failed in a Phase III trial. Rilzabrutinib’s LoA dropped by 17 points to 24% in pemphigus vulgaris and 6 points to 4% in pemphigus foliaceus.

The LoA changed on 13 September after Phase III PEGASUS trial results were reported on 9 September. PEGASUS did not meet its primary endpoint of complete remission with minimal use of corticosteroids from weeks 29 to 37. Data shows the proportion of rilzabrutinib patients that reached this endpoint was not significantly different from the placebo arm.

Rilzabrutinib is a BTK inhibitor also under investigation in autoimmune haemolytic anaemia, asthma, atopic dermatitis, and immune thrombocytopenic purpura. Principia Biopharma ran the Phase III pemphigus trial; it was acquired by Sanofi in August 2020.

Artios bolstered by solid tumour trial start

Artios Pharma’s polymerase theta inhibitor ART-4215 saw its PTSR leap ten points to 21% after its Phase I/IIa solid tumour basket trial began recruiting.

The PTSR change occurred on September 9 following an update on its ClinicalTrials.gov listing on 2 September. The Phase I/IIa is designed to enroll 206 patients. It aims to establish a safe dose of ART-4215 as a monotherapy and in combination with Pfizer’sTalzenna (talazoparib), as well as to explore the safety and efficacy of both approaches. Talzenna, a poly-ADP ribose polymerase inhibitor, received FDA approval in 2018 for patients with HER2-negative metastatic breast cancer.

The Phase I/IIa update also resulted in a two-point bump to oral ART-4215’s LoA, which rose to 5%. Artios is based in Cambridge, UK.

Reponex’s pouchitis asset rises by 10 points

Reponex Pharmaceuticals’ immunostimulator molgramostim saw its PTSR in pouchitis jump by 10 points to 44% on the back of an investigator-led Phase I/II trial starting recruitment. Pouchitis is inflammation that happens in the lining of a pouch made during surgery to treat ulcerative colitis.

The PTSR change went live on 13 September when the 18-patient Phase I/II trial’s ClinicalTrials.gov listing was revised as recruiting on 6 September. Molgramostim is a recombinant granuloctye macrophage colony-stimulating factor (GM-CSF).

The idea is for endoscopically-applied molgramostim to target immunological and bacterial elements of pouchitis. The trial is combining molgramostim with antibiotics metronidazole and fosfomycin; it has a coprimary efficacy endpoint of change in pouchitis disease activity index. The Phase I/II update also increased molgramostim’s LoA by 4 points to 18%.

Pfizer completes Phase I anorexia trial

Pfizer’s MC4 receptor antagonist PF-07258669 saw its PTSR in anorexia nervosa jump by 7 points to 79%. This is due to its Phase I trial’s ClinicalTrials.gov listing updated as completed.

The PTSR change went live on 9 September, two days after the Phase I (NCT04628793) listing was revised (7 September). The update also notes that the trial’s anticipated 24 healthy volunteers increased to 29 actual participants. The Phase I aims to evaluate the safety, tolerability, and pharmacokinetics of single ascending oral doses of PF-07258669 in healthy volunteers.

Due to the Phase I update, PF-07258669’s LoA also increased by 2 points to 22%.

For last week’s regulatory roundup, click here.