MERECA Q&A – English

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In what way are these results positive?
The topline study results show that complete tumor response was reached in 5 out of 45 evaluable patients treated with the combination of ilixadencel and sunitinib. This result in itself was a real surprise to us and to the primary investigators. Complete tumor response is achieved when all signs of cancer disappear in response to the treatment. Tumor eradication is the ultimate goal of all cancer treatments and is rarely achieved in metastatic Renal Cell Carcinoma. Other patients had different degrees of response, like partial response or stable disease

In addition to that, more than half of the patients in the study are still alive which means we have not yet achieved median overall survival rate and is thus also a very positive result.

Another major positive factor is the confirmation of ilixadencel’s excellent safety profile. No difference in terms of safety between the groups implicates that ilixadencel can add a positive impact in efficacy without additional toxicity.

These data validate that ilixadencel has a therapeutic effect and supports the continued clinical development of ilixadencel as an immune primer in solid tumors.

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What does it mean that the median overall survival rate has not yet been reached?
Median overall survival is reached when 50% of the patients have deceased. Since more than half of the patients in the study are still alive, we are not yet able to calculate the median overall survival rate. This is very encouraging data and will be followed-up on a six months basis.

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When will you publish data on the endpoints that wasn’t presented in the press release?

  • Median overall survival rate:
    We are able to calculate the median overall survival rate at the point when more than half of the patients are deceased. These data will be followed up on a six months basis.
  • T-cell infiltration and more details on other endpoints:
    We need to further analyze the data in order to be able to release meaningful results for these endpoints. We expect to be able to present more data before the end of October.

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Why did you make an announcement when the data was not ready?
It is important to understand that under the rules and regulations for listed companies we were obliged to communicate the positive topline data we had received. Therefore, it was not possible to wait until all other data was analyzed.

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Why did the control arm have a better 18 months survival rate than the ilixadencel arm?
The results are in reality very similar and reflect that both treatment groups responded well to the treatment. However, survival at 18 months is too early to draw any conclusions about any differences in the median overall survival rate, and we need to continue to follow these patients for survival which we will do at 6 months intervals.

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It is difficult to understand how these data are related, for example in terms of complete tumor response and overall survival. When will you be able to share knowledge on any other specific question on the data from the MERECA study?
We will be able to answer detailed questions on the data when the full analysis of the study is completed and we inform the market, which we expect to do before the end of October. What was presented on August 29 were the topline results which will be followed by more detailed information after we have the opportunity to analyze the data in more detail.

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