Apollomics Announces Top-line Results for Phase 3 Bridging Trial of Uproleselan in China in Patients with Relapsed or Refractory Acute Myeloid Leukemia

Rhea-AI Summary

Apollomics (NASDAQ: APLM) announced disappointing top-line results from its Phase 3 bridging trial of uproleselan in China for relapsed or refractory acute myeloid leukemia patients. The trial, which enrolled 140 subjects randomized 1:1, failed to demonstrate favorable benefits when comparing uproleselan plus chemotherapy versus chemotherapy alone.

The median overall survival in the uproleselan arm was 9.3 months versus 14.3 months in the chemotherapy-only arm. While the drug was generally well-tolerated, serious adverse events occurred in 43% of uproleselan patients compared to 39% in the control group. Following these results and a previous failed global Phase 3 trial by partner Glycomimetics, Apollomics is concluding the program with expected remaining expenses under $500,000.

Positive

• Drug showed acceptable safety profile with similar tolerability to control arm
• Company limiting further financial exposure with program expenses capped at $500,000

Negative

• Phase 3 trial failed to meet primary endpoint of overall survival improvement
• Uproleselan arm showed worse survival (9.3 months) vs control arm (14.3 months)
• Higher rate of serious adverse events in uproleselan arm (43%) vs control (39%)
• Company forced to terminate development program
• Previous investment resulted in write-down of intangible assets

News Market Reaction

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+4.06% News Effect

On the day this news was published, APLM gained 4.06%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

FOSTER CITY, Calif., Dec. 20, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced today the results from its Phase 3 bridging trial of uproleselan in China in patients with relapsed or refractory acute myeloid leukemia. The trial did not demonstrate favorable benefit for uproleselan.

The Phase 3 trial was a randomized, double-blinded bridging trial to evaluate the safety and efficacy of uproleselan administered with chemotherapy versus chemotherapy alone in patients with relapsed or refractory acute myeloid leukemia. The primary endpoint was comparing overall survival (OS) in the uproleselan treatment arm versus the control arm. A total of 140 subjects were enrolled in the Phase 3 trial and randomized 1:1 to receive either uproleselan with chemotherapy (n=69) or chemotherapy alone (n=71). The median OS in the uproleselan arm was 9.3 months (95% CI 6.1 – 16.0 months) versus 14.3 months (95% CI 6.2 – NA months) in the chemotherapy-only arm (p=0.48). Addition of uproleselan to chemotherapy was generally well tolerated, with a similar safety profile to the control arm. The incidence of serious adverse events was 43% in the uproleselan arm versus 39% in the chemotherapy-only arm. The most common serious adverse events in the uproleselan arm were decreased platelet count, infectious pneumonia, and sepsis.

“While we are disappointed that uproleselan did not show a clinical benefit, the results were expected given that the global Phase 3 trial of uproleselan in a similar patient population by our partner, Glycomimetics, did not meet its primary endpoint earlier this year. Our regulatory and commercial strategy in China has always required a positive global Phase 3 trial, and therefore we are currently wrapping up this program,” said Guo-Liang Yu, PhD, Chairman and CEO of Apollomics. “We extend our thanks and gratitude to all the patients and their families, investigators and clinical team that supported the trial.”

In August 2024, Apollomics announced the write-down of the intangible asset related to the upfront payment for the uproleselan program. Apollomics is concluding the clinical trial and expects future expenses for the uproleselan program to be less than $500,000.

The Company intends to submit the full results of this trial for presentation at a future medical conference.

About Apollomics Inc.

Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead program is vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States and over 10 other countries. For more information, please visit www.apollomicsinc.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding the Company’s strategy, prospects, plans and objectives are forward-looking statements, including statements about the conclusion, expenses and results of the Phase 3 bridging trial. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations and the continued listing of Apollomics’ securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) the failure to protect Apollomics’ intellectual property; (v) breaches in data security; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and (viii) those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2023, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date made by the Company. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law.

Investor Contact:

Eric Ribner
LifeSci Advisors, LLC
(646) 751-4363
eric@lifesciadvisors.com

FAQ

What were the results of APLM's Phase 3 uproleselan trial in China?

The Phase 3 trial failed to show favorable benefits, with median overall survival of 9.3 months in the uproleselan arm versus 14.3 months in the chemotherapy-only arm.

How many patients were enrolled in APLM's Phase 3 uproleselan trial?

The trial enrolled 140 subjects, randomized 1:1 with 69 patients receiving uproleselan with chemotherapy and 71 receiving chemotherapy alone.

What are the financial implications of the failed uproleselan trial for APLM?

Apollomics has written down the intangible asset related to the upfront payment and expects remaining program expenses to be less than $500,000.

What were the safety results of APLM's uproleselan Phase 3 trial?

The drug was generally well-tolerated but showed 43% serious adverse events in the uproleselan arm versus 39% in the control arm, with main events including decreased platelet count, infectious pneumonia, and sepsis.

What is APLM's next step following the uproleselan trial results?

Apollomics is concluding the clinical trial program and plans to submit the full results for presentation at a future medical conference.