This week on Pipeline Moves, we kick off by looking at the termination of a Phase II investigator-led trial of Roche’s Tecentriq in relapsed/refractory cutaneous T-cell lymphoma after an urgent safety measure.
Meanwhile, SGZ Biotechnologies dealt a double blow after terminating two trials of their oncology candidates and Celldex terminated a Phase II pancreatic cancer trial.
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On a positive note, Viking Therapeutics has announced a Phase II trial of its obesity candidate has met its endpoints.
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Roche’s Tecentriq (atezolizumab) saw its Phase Transition Success Rate (PTSR) decline following the termination of an investigator-led Phase II trial. The drug’s PTSR decreased by 14 points to 19% in cutaneous T-cell lymphoma, 17 points to 16% in Sezary syndrome, and 20 points to 21% in mycosis fungoides. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. The study was sponsored by the European Organisation for Research and Treatment of Cancer (EORTC).
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The trial’s status was updated on its ClinicalTrials.gov from ongoing, not recruiting to terminated on 23 February and GlobalData evaluated the asset on the same day. The study was terminated after an urgent safety measure due to toxicity and recruitment was closed prematurely, according to the trial’s ClinicalTrials.gov listing. No further details were listed on ClinicalTrials.gov.
The Phase II trial (NCT03357224) evaluated Tecentriq in 26 patients with stage IIb-IV mycosis fungoides/Sezary syndrome and cutaneous T-cell lymphoma, who received previous systemic treatment. The study’s primary endpoint assessed the best overall response rate for a period of up to a year post patient registration. Mycosis fungoides and Sezary syndrome are types of cutaneous T-cell lymphoma that affect the skin, due to lymphocytes becoming malignant.
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By GlobalDataTecentriq is a programmed cell death 1 ligand 1 (PD-L1) inhibitor that is marketed for the treatment of patients with lung cancer, soft tissue sarcoma and bladder cancer, among other conditions.
Phase II obesity trial meets endpoints
Viking Therapeutics’s VK-2735 has seen its PTSR increase in obesity after a Phase II trial reported positive topline results. The PTSR for the drug increased by 16 points to 39% in obesity.
Viking announced positive topline results from the Phase II Venture trial (NCT06068946) in a press release on 27 February. GlobalData evaluated the asset the following day.
The trial investigated the varying doses of the candidate versus placebo in 176 patients over a 13-week treatment period. There were five arms to the study, four treatment arms with varying doses (2.5mg, 5mg, 10mg and 15mg) and a placebo arm.
The results showed patients who received weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, up to a 14.7% change from baseline.
The candidate also demonstrated statistically significant differences relative to placebo on the key secondary endpoint of assessing the proportion of patients demonstrating at least 10% weight loss.
VK2735 was safe and well tolerated in the trial with most adverse events being mild or moderate.
Based on these findings, Viking intends to meet with the FDA to discuss next steps with the candidate.
VK-2735 is a dual GLP-1R/GIPR agonist. Activated GLP1R stimulates the adenylyl cyclase pathway to increase insulin synthesis and release. The GIP-R binds to glucose dependant insulinotropic polypeptide to induce insulin release.
Amgen’s daxdilimab prospects for transition rise after completion
Amgen’s daxdilimab saw a nine-point rise in its PTSR, settling at 40% in alopecia areata, following a Phase II trial completion.
The study’s (NCT05368103) status on ClinicalTrials.gov changed from active, not recruiting to completed on 23 February, and GlobalData evaluated the asset on 27 February.
The Phase IIa open-label, proof-of-concept trial, investigated the preliminary efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of daxdilimab for the treatment of moderate to severe alopecia areata. The study assessed the percent change from baseline in the Severity of Alopecia Tool (SALT) score at week 24 as its primary endpoint.
Amgen is developing daxdilimab to treat several autoimmune disorders including lupus erythematosus, dermatomyositis, and lupus nephritis. The therapy acts as an immunoglobulin-like transcript 7 (ILT-7) antagonist, inhibiting the production of IFN-alpha, thus reducing autoimmune symptoms.
Double blow for SGZ Biotechnologies
SQZ Biotechnologies saw the PTSR decrease in two of their candidates after a Phase I/II trial (NCT05357898) of its PBMC vaccine, SQZ-eAPC-HPV, and a Phase I trial (NCT04892043) of SQZ-AAC were both terminated.
The PTSR for SQZ-eAPC-HPV dropped by 16 points to 23% in vaginal cancer, 14 points to 19% in vulvar cancer, and 13 points to 17% in anal cancer.
SQZ’s PBMC vaccine elicits immunostimulant activity by targeting E6 and E7 antigens on HPV- positive cancers.
The purpose of the first-in-human, open-label, multi-centre study was to assess the safety, antitumor activity, immunogenic, and pharmacodynamic effects of PBMC vaccine as a monotherapy and in combination with Merck’s Keytruda (pembrolizumab) in patients with recurrent, locally metastatic HPV16+ solid tumours. The study enrolled 20 patients before being terminated.
While SQZ-AAC saw its PTSR drop by 16 points to 17% in vaginal cancer, 19 points to 14% in vulvar cancer, 19 points to 13% in cervical cancer, and 12 points to 12% in anal cancer.
SQZ-AAC elicits immunostimulant activity. The cell therapy candidate was under development for the treatment of HPV16+ solid tumours.
The purpose of the open-label, multi-centre study was to assess the safety, tolerability, antitumor activity, immunogenic, and pharmacodynamic effects of SQZ-AAC as a monotherapy and in combination with immune checkpoint inhibitors in patients with HPV16+ solid tumours. The study enrolled five patients before being terminated.
The status of both trials was updated from completed to terminated on ClinicalTrials.gov on February 23, with the ClinicalTrials.gov listings stating the trials were terminated by the sponsor due to a corporate decision, not due to safety or efficacy.
Celldex terminate Phase II pancreatic cancer trial
Celldex Therapeutics’s CDX-1140 and CDX-301 saw their PTSR decrease in pancreatic ductal adenocarcinoma after a Phase II trial was terminated. CDX-1140’s PTSR dropped by 15 points to 13% and CDX-301’s dropped by 17 points to 16%.
The Phase II trial’s (NCT05673876) status was updated from completed to terminated on ClinicalTrials.gov on 20 February, and GlobalData evaluated the asset the following day. The study’s ClinicalTrials.gov listing does not provide any additional information apart from saying, the study was terminated by Celldex.
The purpose of the study was to test the immunologic effects of CDX-1140 and CDX-301 in patients with pancreatic cancer. The study enrolled 16 patients before being terminated and was sponsored by Washington University School of Medicine.
CDX-1140 acts as a CD40 agonist and is under development for the treatment of metastatic biliary tract cancer, epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, endometrial cancer, and triple negative breast cancer.
CDX-301 is a recombinant FMS-like tyrosine kinase 3 ligand (Flt3L) and is under development for the treatment of low-grade B-cell lymphomas, marginal zone lymphoma, follicular lymphoma, cutaneous T-cell lymphoma, mycosis fungoides, non-small cell lung cancer, metastatic or unresectable triple negative breast cancer, small lymphocytic lymphoma, head and neck squamous cell carcinoma and cutaneous melanoma (skin cancer).
Phase I/II solid tumour trial completes
Mereo’s MPH313 (etigilimab) saw its PTSR increase following a Phase I/II trial completion in advanced and metastatic solid tumours. The drug’s PTSR rose by 16 points and reached 46% in cervical cancer.
The trial’s status was updated on its ClinicalTrials.gov from ongoing, not recruiting to completed on 22 February and GlobalData evaluated the asset on the next day.
The open-label Phase Ib/II trial (NCT04761198) evaluated the efficacy, safety and tolerability of MPH313 combined with Bristol Myers Squibb’s Opdivo (nivolumab) in subjects with locally advanced or metastatic solid tumours. The study originally aimed to recruit 125 participants but ended up enrolling only 76 subjects. The participants were assigned to receive MPH313 every two weeks in combination with Opdivo until either unacceptable toxicity or disease progression occurs. The trial’s primary endpoint evaluated the objective response rate for a time period of up to 24 months post-treatment.
Etigilimab is an antagonist of TIGIT, an immune checkpoint. TIGIT plays a role in the regulation of T-cell-mediated immune response by inhibiting T-cell activation, proliferation, cytokine production and development of cytotoxic activity. The drug is a monoclonal antibody that elicits a therapeutic response by antagonising TIGIT to produce an anti-tumour response.
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Pipeline Moves: Approval prospects for Roche’s tiragolumab rise in oesophageal squamous cell carcinomaNeed 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.
