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

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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.

Apollomics (NASDAQ: APLM) ha annunciato risultati deludenti per quanto riguarda i dati preliminari del suo studio di fase 3 in Cina su uproleselan per pazienti con leucemia mieloide acuta recidivante o refrattaria. Lo studio, che ha arruolato 140 soggetti randomizzati in un rapporto 1:1, non è riuscito a dimostrare benefici favorevoli confrontando uproleselan più chemioterapia rispetto alla sola chemioterapia.

La sopravvivenza globale mediana nel braccio di trattamento con uproleselan è stata di 9,3 mesi rispetto a 14,3 mesi nel braccio chemioterapia sola. Sebbene il farmaco sia stato generalmente ben tollerato, eventi avversi gravi si sono verificati nel 43% dei pazienti trattati con uproleselan rispetto al 39% nel gruppo di controllo. Dopo questi risultati e un precedente insuccesso dello studio globale di fase 3 condotto dal partner Glycomimetics, Apollomics sta concludendo il programma con spese rimanenti previste al di sotto di $500.000.

Apollomics (NASDAQ: APLM) anunció resultados decepcionantes en cuanto a los resultados preliminares de su ensayo de fase 3 con uproleselan en China para pacientes con leucemia mieloide aguda en recaída o refractaria. El ensayo, que inscribió a 140 sujetos aleatorizados en una proporción de 1:1, no logró demostrar beneficios favorables al comparar uproleselan más quimioterapia versus solo quimioterapia.

La supervivencia global mediana en el grupo de uproleselan fue de 9.3 meses frente a 14.3 meses en el grupo de quimioterapia solamente. Aunque el fármaco fue generalmente bien tolerado, se produjeron eventos adversos graves en el 43% de los pacientes tratados con uproleselan en comparación con el 39% en el grupo de control. Tras estos resultados y un anterior ensayo global de fase 3 fallido por parte del socio Glycomimetics, Apollomics está concluyendo el programa con gastos restantes esperados por debajo de $500,000.

아폴로믹스 (NASDAQ: APLM)는 재발성 또는 불응성 급성 골수성 백혈병 환자를 위한 중국에서의 우프로세란 제3상 브리징 시험에서 실망스러운 최고 결과를 발표했습니다. 140명의 피험자를 1:1로 무작위 배정한 이번 시험은 우프로세란과 화학요법을 비교했을 때 유리한 혜택을 입증하는 데 실패했습니다.

우프로세란 군의 중앙 전체 생존 기간은 9.3개월였고, 화학요법 단독 군은 14.3개월였습니다. 이 약물은 일반적으로 잘 견디는 것으로 평가되었지만, 우프로세란 환자의 43%에서 심각한 부작용이 발생한 반면, 대조군에서는 39%에서 발생했습니다. 이러한 결과와 파트너인 글라이코미메틱스의 이전 글로벌 제3상 시험 실패에 따라 아폴로믹스는 남은 비용이 $500,000 미만으로 예상되는 프로그램을 종료할 예정입니다.

Apollomics (NASDAQ: APLM) a annoncé des résultats décevants concernant les données préliminaires de son essai de phase 3 sur l'uproleselan en Chine, destiné aux patients atteints de leucémie myéloïde aiguë en rechute ou réfractaire. L'essai, qui a recruté 140 sujets randomisés dans un rapport de 1:1, n'a pas réussi à démontrer d'avantages favorables en comparant uproleselan plus chimiothérapie par rapport à la chimiothérapie seule.

La survie globale médiane dans le groupe uproleselan était de 9,3 mois contre 14,3 mois dans le groupe uniquement chimiothérapie. Bien que le médicament ait été généralement bien toléré, des événements indésirables graves sont survenus chez 43 % des patients ayant reçu l'uproleselan, contre 39 % dans le groupe de contrôle. Suite à ces résultats et à un précédent essai mondial de phase 3 infructueux mené par le partenaire Glycomimetics, Apollomics conclut le programme avec des dépenses restantes estimées à moins de 500 000 $.

Apollomics (NASDAQ: APLM) hat enttäuschende Ergebnisse aus seiner Phase-3-Überbrückungsstudie mit Uproleselan in China bei Patienten mit rezidivierter oder refraktärer akuter myeloischer Leukämie bekannt gegeben. Die Studie, die 140 Probanden im Verhältnis 1:1 randomisiert hat, konnte bei dem Vergleich von Uproleselan plus Chemotherapie mit nur Chemotherapie keine vorteilhaften Effekte nachweisen.

Die mediane Gesamtüberlebenszeit in der Uproleselan-Gruppe betrug 9,3 Monate im Vergleich zu 14,3 Monaten in der Gruppe mit nur Chemotherapie. Obwohl das Medikament im Allgemeinen gut vertragen wurde, traten bei 43 % der Uproleselan-Patienten im Vergleich zu 39 % der Kontrollgruppe schwerwiegende unerwünschte Ereignisse auf. Nach diesen Ergebnissen und einem zuvor gescheiterten globalen Phase-3-Versuch des Partners Glycomimetics wird Apollomics das Programm mit verbleibenden Kosten von voraussichtlich unter 500.000 USD abschließen.

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

Insights

The Phase 3 bridging trial results for uproleselan represent a significant setback for Apollomics. The trial data shows that adding uproleselan to chemotherapy provided no survival benefit and potentially worse outcomes, with median overall survival of 9.3 months versus 14.3 months in the chemotherapy-only arm. The lack of efficacy aligns with the earlier failed global Phase 3 trial by partner Glycomimetics, effectively ending uproleselan's commercial prospects in China.

The financial impact is already partially absorbed through the August 2024 intangible asset write-down. With remaining program expenses capped at $500,000, the immediate financial exposure is However, this represents the loss of a potential revenue stream in the lucrative Chinese market for relapsed/refractory AML treatment.

For a company with a market cap of only $8.7 million, losing a late-stage asset significantly narrows the pipeline and future growth prospects. This raises concerns about Apollomics' ability to successfully develop and commercialize its remaining oncology candidates.

The trial results reveal critical insights about targeting E-selectin in refractory AML. The similar adverse event profiles between arms (43% vs 39%) suggest uproleselan's safety wasn't the issue. Rather, the data indicates that inhibiting E-selectin-mediated cell adhesion may be insufficient to meaningfully improve outcomes in this patient population.

The shorter median survival in the uproleselan arm (9.3 vs 14.3 months) raises questions about potential antagonistic effects with chemotherapy. This finding is particularly concerning as it suggests the drug might interfere with standard treatment efficacy. The confidence intervals and p-value of 0.48 indicate the survival difference wasn't statistically significant, but the numerical trend is unfavorable.

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.

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