TRACON Pharmaceuticals Provides Update on Ongoing ENVASARC Phase 2 Pivotal Trial Following Independent Data Monitoring Committee Recommendation to Continue the Trial as Planned
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The findings from the ENVASARC Phase 2 pivotal trial are significant for the field of oncology, particularly for the treatment of refractory sarcoma subtypes such as UPS and MFS. The reported objective response rate (ORR) of 11% by investigator review and the confirmed ORR of 5.5% may seem modest, but in the context of these aggressive cancers, these figures can represent a meaningful advancement. The duration of response exceeding six months is encouraging, as it suggests a level of durability in the antitumor activity of envafolimab.
Moreover, the absence of drug-related serious adverse events of grade 3 or higher is noteworthy. This safety profile, if consistent with further data, could make envafolimab a preferred option for patients intolerant to more toxic treatments. However, it is important to maintain a cautious optimism until the final data set is available, as interim results can evolve with the accumulation of more data and longer follow-up times.
From a research analysis perspective, the completion of enrollment for the ENVASARC trial is a critical milestone for TRACON Pharmaceuticals. The data monitoring committee's recommendation to continue the trial as planned indicates no significant safety concerns were identified in the interim analysis, which is a positive signal for potential investors and partners. However, the disparity between the investigator and blinded independent central review (BICR) ORRs warrants attention. The lower confirmed ORR by BICR may impact the perceived effectiveness of envafolimab, possibly affecting future regulatory decisions and market confidence.
Investors should also consider the implications of the primary and secondary endpoints. Achieving the primary endpoint of an 11% ORR by BICR in the 82 patient cohort is a binary outcome that could substantially influence TRACON's stock performance. A median duration of response greater than six months as a secondary endpoint further underscores the potential for envafolimab to offer a durable treatment option, which could be a deciding factor in its commercial success. The upcoming final data in the third quarter of 2024 will be pivotal in shaping the drug's trajectory and the company's valuation.
Envafolimab's progress through clinical trials is closely watched by market analysts due to its potential impact on the sarcoma treatment landscape. The refractory sarcoma market is a niche but underserved area and new therapies can command significant market share if proven effective. TRACON's PDP approach, which emphasizes cost-efficiency and independence from contract research organizations (CROs), could give it a competitive edge in terms of speed and cost of development, potentially leading to attractive pricing strategies upon market entry.
However, the current market reaction may be tempered by the mixed results—while the safety profile is favorable, the efficacy as measured by ORR is not overwhelmingly positive. The final data will be important in determining envafolimab's market potential. Investors should monitor not only the clinical outcomes but also the company's plans for commercialization, potential partnerships and overall strategy to capitalize on the trial results.
ENVASARC Trial is Fully Enrolled and Final Data are Expected in Third Quarter 2024
SAN DIEGO, April 03, 2024 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent Product Development Platform (PDP) to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced the independent data monitoring committee (IDMC), following a review of ongoing safety and efficacy data on April 2, recommended the ENVASARC Phase 2 pivotal trial continue as planned. The ENVASARC Phase 2 pivotal trial completed enrollment in March 2024 with a total of 82 evaluable patients in cohort C of treatment with single agent envafolimab at 600 mg SQ every three weeks and final data are expected in the third quarter of 2024.
The IDMC reviewed interim safety and efficacy data from 73 patients enrolled into cohort C who had the opportunity to complete two on-treatment scans (a minimum of 12 weeks of treatment). The objective response rate (ORR) is currently
“Subcutaneous envafolimab has been generally well tolerated and continues to demonstrate durable single agent activity in a subset of these sarcoma patients,” said James Freddo, M.D., TRACON’s Chief Medical Officer. “An additional five objective responses confirmed by central review are needed to achieve our goal in the 82 patient cohort of single agent envafolimab treatment.”
“We believe that achievement of the primary endpoint in the ENVASARC trial would position envafolimab to become a potentially compelling treatment option for patients with the refractory sarcoma subtypes of UPS and MFS,” said Charles Theuer, M.D., Ph.D., TRACON’s Chief Executive Officer
About ENVASARC (NCT04480502)
The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. The primary endpoint is ORR by blinded central review of nine responses in cohort C of 82 evaluable patients with duration of response a key secondary endpoint. The trial is fully enrolled and the primary endpoint will continue to be evaluated.
About TRACON
TRACON utilizes a cost-efficient, CRO-independent, product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies. TRACON believes it can serve as a solution for companies without clinical capabilities who wish to become CRO-independent. To learn more about TRACON, visit TRACON’s website at www.traconpharma.com.
Forward-Looking Statements
Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s expectations for the timing and scope of its clinical trials as well as timely achievement of expected endpoints and goals, the timing and expected results of clinical data, whether the ENVASARC trial will achieve its primary endpoint, and the potential for envafolimab to become a treatment option for patients with the refractory sarcoma subtypes of UPS and MFS. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development and regulatory approval of pharmaceutical product candidates; risks relating to TRACON’s ability to continue as a going concern; risks relating to cost variability of clinical trials; whether other therapies are developed and compete with TRACON’s product candidates; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with macroeconomic and geopolitical events; the fact that future clinical results may not be consistent with preliminary results or results from prior studies; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing on favorable terms or at all; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.
| Company Contact: | Investor Contact: |
| Charles Theuer | Brian Ritchie |
| Chief Executive Officer | LifeSci Advisors LLC |
| (858) 550-0780 | (212) 915-2578 |
| ctheuer@traconpharma.com | britchie@lifesciadvisors.com |
