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Other Disclosures4598Delta-Fly Pharma,Inc.Pharmaceuticals

Results of a Phase II trial of DFP-14323 in combination with low-dose afatinib published in Therapeutic Advances in Medical Oncology

Results of a Phase 2 trial of DFP-14323 (ubenimex) in combination with low-dose afatinib in patients with EGFR mutation-positive non-small-cell lung cancer have been published in a peer-reviewed international medical journal. The publication formally reports the trial results as a research paper and does not indicate approval or the launch of sales of the treatment.

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50Recurring
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Announced details

DFP-14323 (generic name: ubenimex)Combination therapy with low-dose afatinib
Applicable field (uses covered by this announcement)

First-line treatment for advanced or recurrent EGFR mutation-positive non-small-cell lung cancer (NSCLC)

What the company reported numerically
Quantitative Effects

Disease control rate (DCR): 100%; objective response rate (ORR): 69.2%; median progression-free survival (PFS): 23.1 months. No Grade 4–5 adverse events or treatment-related deaths were observed.

Usage history

26 patients enrolled (Phase 2 trial)

Relationship between the counterparty and the company
Delta-Fly Pharma,Inc.4598
Relationship with the Company

The company is advancing the development of DFP-14323.

Impact on Business Performance

No impact on business performance stated

The company does not address Contract Value / Offering price.

Source (materials cited by the company)

Therapeutic Advances in Medical Oncology、Volume 18, 2026、DOI: 10.1177/17588359261483551

Announced details
ItemDetails
Names of Products / Services CoveredDFP-14323 (generic name: ubenimex), Combination therapy with low-dose afatinib
Relationship with the CompanyThe company is advancing the development of DFP-14323.
Applicable areaFirst-line treatment for advanced or recurrent EGFR mutation-positive non-small-cell lung cancer (NSCLC)
Quantitative EffectsDisease control rate (DCR): 100%; objective response rate (ORR): 69.2%; median progression-free survival (PFS): 23.1 months. No Grade 4–5 adverse events or treatment-related deaths were observed.
Usage history26 patients enrolled (Phase 2 trial)
Impact on Business PerformanceNo impact on business performance stated
SourceTherapeutic Advances in Medical Oncology、Volume 18, 2026、DOI: 10.1177/17588359261483551
Items this document does not state (11)
CounterpartyCounterparty overviewContract ValueOffering priceContract DateLaunch dateAward/certification nameAwarding / certifying bodyRegistration number and expiry dateLocationLocation scale

These are items the company does not state in this document. We do not leave them blank, nor fill them in from other sources or by inference.

The reasons the company gives

The company's own explanation, not something inferred from the numbers.

The clinical trial results previously presented at academic conferences and other venues have now been formally reported in a peer-reviewed international medical journal. The company also stated that it will advance the treatment's clinical development going forward.

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Results of a Phase II trial of DFP-14323 in combination with low-dose afatinib published in Therapeutic Advances in Medical Oncology | Delta-Fly Pharma,Inc. (4598) timely disclosure | Komori