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Imugene Limited’s (ASX:IMU) HER-Vaxx Delivers Promising Results in Phase 2 Interim Analysis

  • November 24, 2020 03:11 PM AEDT
  • Kunal Sawhney
    CEO Kunal Sawhney
    2345 Posts

    Kunal Sawhney is founder & CEO at Kalkine and is a richly experienced and accomplished financial professional with a wealth of knowledge in the Australian Equities Market. Kunal obtained a Master of Business Administration degree from University of T...

Imugene Limited’s (ASX:IMU) HER-Vaxx Delivers Promising Results in Phase 2 Interim Analysis

Summary

  • Imugene Limited (ASX:IMU) has recently shared promising interim data from its continuing Phase 2 trial of HER-Vaxx.
  • The interim analysis results demonstrated that twice as many patients survived on the HER-Vaxx plus SOC chemotherapy group in contrast to the SOC chemotherapy alone.
  • The data indicated that the HER-Vaxx does not add toxicity to standard-of-care chemotherapy.
  • The median OS for patients obtaining HER-Vaxx along with chemotherapy was ~14.2 months in contrast to 8.8 months in patients receiving chemotherapy alone.
  • The IDMC provided guidance that it is ethically and scientifically appropriate to lower the overall number of patients to complete the trial.
  • The committee also agreed that the interim analysis data is strongly positive to conclude that HER-Vaxx and SOC chemotherapy combination is safe.
Gold MTF non-AMP

Imugene Limited (ASX:IMU) has recently shared promising interim data from its continuing Phase 2 trial of B-cell immunotherapy, HER-Vaxx. The interim analysis has returned encouraging results in terms of overall survival Hazard Ratio (HR) and median overall survival (OS) in the randomized Phase 2 trial of HER-Vaxx in advanced gastric cancer.

The Phase 2 study of HER-Vaxx is designed to measure the safety, efficacy, and immune response in 68 patients suffering from metastatic gastric cancer overexpressing the HER-2 protein. The ongoing Phase 2 trial is randomized into two arms of either standard-of-care (SOC) chemotherapy alone or HER-Vaxx plus standard-of-care chemotherapy.

Imugene is undertaking the study at numerous sites across India and Eastern Europe where clinicians face difficulty in accessing approved antibody treatments like Herceptin® and Perjeta® sold by Roche Holding AG. Besides, there is a high prevalence of gastric cancer in these countries.

Recently, Imugene has also released its Investor Presentation for November 2020 and Annual General Meeting Presentation on the ASX. Following the release of presentations, IMU shares traded ~8.7 per cent higher at $0.125 during the early trading session on 24 November 2020.

Favourable Interim Analysis Results

The HER-Vaxx Phase 2 study that was designed with a specified 1-sided false positive probability of 0.10 demonstrated in the interim analysis that twice as many patients survived on the HER-Vaxx plus SOC chemotherapy group in contrast to the SOC chemotherapy alone.

This translated to a statistically significant overall survival HR of 0.418 (80% two-sided CI: 0.186, 0.942), with a 1-sided p-value of 0.083.

It is worth mentioning that the Phase 3 ToGA trial, which tested the effect of Herceptin combined with chemotherapy versus chemotherapy alone in advanced gastric cancer, delivered an overall survival HR of 0.74 in historical data. Importantly, this Phase 3 ToGA trial was intent-to-treat analysis of the similar patient population of HER2 overexpressing patients, as included in the HER-Vaxx Phase 2 study.

Besides, the HER-Vaxx indicated a reduced risk of death of 58.2 per cent in the HER-Vaxx plus chemotherapy treatment arm as against SOC chemotherapy control arm. Significantly, there was not any difference in safety events between the two treatment arms, indicating that the HER-Vaxx does not add toxicity to standard-of-care chemotherapy.

The median overall survival (OS) for patients obtaining HER-Vaxx along with chemotherapy was about 14.2 months in contrast to 8.8 months in patients receiving chemotherapy alone. Imugene notified that the longest HER-Vaxx treated patient stays progression-free and on therapy 16.3 months after dosing.

Second IDMC Review Completed

The second Independent Data Monitoring Committee (IDMC) review of HER-Vaxx Phase 2 trial has also been completed. The first IDMC review was finalised in Q2 2020, with IDMC validating the safety of HER-Vaxx Phase 2 study.

The safety and efficacy data received from the interim analysis of HER-Vaxx Phase 2 trial were recently reviewed at the IDMC meeting. Following the review, the IDMC confirmed no safety concerns and regarded this preliminary data as strongly advocating an HER-Vaxx survival effect.

The IDMC endorsed a positive survival outcome with no added toxicity for HER-Vaxx plus SOC chemotherapy over chemotherapy alone. Besides, the committee provided guidance that it is ethically and scientifically appropriate to lower the overall number of patients to complete the trial.

The IDMC advised reducing the number of required events and the overall number of patients to approximately 34, given the strong indication that it would be considered unethical to enrol 68 patients as initially planned.

The IDMC agreed that the interim analysis data is strongly positive to conclude that HER-Vaxx and SOC chemotherapy combination is safe.

The HER-Vaxx Phase 2 interim analysis safety and efficacy data represent a clinical proof-of-concept signal for Imugene’s HER-Vaxx when combined with chemotherapy. The data primarily indicate that B-cell activating immunotherapy vaccines can encourage clinically active antibody responses.

Related Read: Imugene (ASX:IMU) Wins FDA IND Approval to Kick Off PD1-Vaxx’s Phase 1 Trial in US

 

 


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