Peptide education
LTX-315
Ruxotemitide · VP-315
LTX-315, also called ruxotemitide, is an investigational peptide injected directly into accessible tumors in cancer studies. It has been studied alone and with immune checkpoint treatment.
Early studies report local tumor changes and responses in a small combination group, but the cited studies have no randomized comparator. Serious hypersensitivity was reported in phase 1.
Overview
Quick answer
Shrinkage of one injected lesion is not the same as an objective response assessment. In the cited phase 1 study, the immune-related assessment excluded the injected lesion from tumor burden. Combination results cannot be attributed to LTX-315 alone.
Is LTX-315 FDA-approved?
Exact openFDA active-ingredient and brand-name searches found no matches for LTX-315, ruxotemitide, or VP-315. Trial authorization is not marketing approval; other names and jurisdictions require separate checks.
What did the solid tumor study find?
Seven of 24 evaluable patients had more than 30% regression in an injected lesion. Separately, none of 27 evaluable patients had an objective response by immune-related criteria, which assessed tumor burden excluding the injected lesion.
What did the melanoma combination study report?
Registry-posted results for LTX-315 plus pembrolizumab describe three partial responses in an efficacy population of 22 participants, one of whom was classified as not evaluable for response. The study included mostly patients with advanced melanoma and had no comparison arm.
What are the main safety concerns?
The phase 1 report described low blood pressure, flushing, injection-site reactions, and severe hypersensitivity or anaphylaxis.
Evidence
Evidence snapshot
The monotherapy dose-ranging study involved accessible solid tumors. Local lesion measurements and immune-related response criteria are different outcomes.
The registry reports results for LTX-315 plus pembrolizumab, not for LTX-315 alone. One enrolled participant had a non-melanoma diagnosis.
A VP-315 study evaluated injected basal cell lesions before excision. Its cohort results should not be mixed with melanoma outcomes.
Serious reactions and transient blood-pressure changes were observed in the phase 1 study.
Claims
Common claims vs evidence
| Claim | Human evidence | Verdict |
|---|---|---|
| Shrinkage at the injection site proves a systemic cancer response. | Seven of 24 evaluable patients had more than 30% regression in an injected lesion. No objective responses were reported among 27 patients evaluated by immune-related criteria, excluding the injected lesion. | Local lesion response should not be substituted for an overall response. |
| Responses with pembrolizumab prove LTX-315 adds benefit. | The phase 2 study gave both medicines to all participants and posted results without a pembrolizumab-only group. | The uncontrolled combination results cannot establish the added effect. |
Bottom line
Main takeaway
LTX-315 is an experimental cancer treatment; exact FDA searches found no match under the names reviewed.
A change in an injected lesion is not automatically a response across the whole cancer.
The cited solid tumor and melanoma studies are uncontrolled; the latter reports a combination outcome.
Identity
What it is
The nine-amino-acid peptide has been injected into accessible tumors during dose-ranging research. Ruxotemitide is another name for LTX-315.
Research
Research evidence
The solid tumor publication, melanoma combination study, and basal cell carcinoma study involve different populations and endpoints.
| Study / evidence area | Population | Design | Product context | Main outcome | Limitations | Weight |
|---|---|---|---|---|---|---|
| Phase 1 monotherapy dose-ranging study | 39 patients with advanced solid tumors accessible for injection | Uncontrolled phase 1 study | LTX-315 alone, injected into accessible tumor lesions | Seven of 24 evaluable patients had more than 30% regression in an injected lesion. No objective responses occurred among 27 patients assessed by immune-related criteria excluding the injected lesion. | Small study with no randomized comparator; local and overall outcomes differ. | Early uncontrolled human evidence |
| ATLAS-IT-05 | 23 participants, mostly with advanced melanoma after prior checkpoint therapy | Open-label, single-arm phase 2 combination study | Intratumoral LTX-315 plus intravenous pembrolizumab | Registry results report three partial responses and no complete responses in the efficacy population of 22 participants, including one participant classified as not evaluable for response. | No comparator; one enrolled participant had a non-melanoma diagnosis. The result cannot isolate the contribution of LTX-315. | Registry-posted uncontrolled combination results |
| VP-315 basal cell carcinoma study | 92 adults with biopsy-confirmed basal cell carcinoma | Open-label, nonrandomized phase 2 study with a safety run-in | Intratumoral VP-315 followed by lesion excision | The registry reports one dose-limiting toxicity among 10 people in the safety run-in and reports histological clearance by later cohort. | Cohort-specific results have no randomized comparator and are not evidence that the drug can replace standard care. | Registry-posted uncontrolled study results |
Use context
Reported use context
These are protocol details from supervised cancer research, not instructions for use or an approved regimen.
Study and label context
Cohorts received 3, 4, or 5 mg per injection, once daily on two consecutive days in each of the first three weeks.
Study-reported only, not a recommendation.Cautions
Safety and unknowns
- In the phase 1 study, treatment-related low blood pressure, flushing, and injection-site reactions were reported. Severe hypersensitivity or anaphylaxis also occurred.
- Small uncontrolled studies cannot establish comparative safety, uncommon harms, or the contribution of each drug in a combination.
Product quality
Product identity and quality
The trial used investigational material under a clinical protocol. An unrelated product's name does not verify its identity, sterility, or suitability for injection.
Approval status
The exact-name FDA search covered three specified names, not every name or jurisdiction.
Mechanism
How it is proposed to work
LTX-315 can disrupt cell membranes and is studied for effects within injected tumors.
Researchers observed tumor tissue injury and changes in immune cells in some biopsies. These observations are not proof of a durable treatment benefit.
FAQ
Common questions
Does shrinkage of an injected tumor mean a systemic response?
No. In the early trial, local lesion shrinkage was distinct from the immune-related response assessment, which found no objective responses among 27 evaluable patients and excluded the injected lesion from tumor burden.
Details
Technical details
Sources
References
- 1.
doi:10.1158/1078-0432.CCR-20-3435 PMID:33542073 NCT01986426
Early monotherapy dose-ranging study of accessible solid tumors; local lesion shrinkage is not a systemic response rate.
- 2.
ClinicalTrials.gov. A study of LTX-315 in patients with transdermally accessible tumors
NCT01986426
Registry describes separate monotherapy and combination arms and their schedules.
- 3.
ClinicalTrials.gov. Intratumoral injection of LTX-315 in combination with pembrolizumab in advanced melanoma
NCT04796194
Single-arm phase 2 registry-posted combination results, including one participant recorded with a non-melanoma diagnosis.
- 4.
ClinicalTrials.gov. Open-label proof of concept study of VP-315 in basal cell carcinoma
NCT05188729
Phase 2 registry-posted results in basal cell carcinoma; cohort outcomes are separate from the melanoma study.
- 5.
Study developer. VP-315 clinical development update
Developer identifies VP-315 as ruxotemitide, formerly LTX-315; this does not establish approval.
- 6.
FDA. Drugs@FDA approved drug products database
Search LTX-315, ruxotemitide, and VP-315 in Drugs@FDA. This link opens the search page, not a saved result.
- 7.
FDA. FDA information about Drugs@FDA coverage
Exact openFDA active-ingredient and brand-name queries for LTX-315, ruxotemitide, and VP-315 found no matches. This page describes database coverage, not the saved results; other names and jurisdictions are not assessed.
- 8.
National Cancer Institute. LTX-315 drug entry
Identifies ruxotemitide as a synonym; does not establish regulatory approval.