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Axelar AB's Phase 2 Lung Cancer Study Data Does Not Impress



12/31/2013 6:55:47 AM

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Axelar announces final data from Phase II study with AXL1717 in lung cancer

STOCKHOLM, SWEDEN - December 27, 2013. Axelar AB announced today the final results from its Phase II study AXL-003 in patients with non-small cell lung cancer (NSCLC). The final data showed no statistically significant difference in rate of progression-free survival (PFS) between the patients treated with AXL1717 compared with the group treated with docetaxel, which confirms the previously communicated preliminary data. A conference call will be held today at 1.00pm CET.

“Although we did not see an improved outcome for the patients with NSCLC that received AXL1717 compared to patients receiving docetaxel, we are still encouraged by the results from AXL-003. The clinical data taken together with new data on a second mechanism of action suggest that AXL1717 has the potential to be developed for patients that have relapsed after treatment with docetaxel in this difficult to treat indication”, says Mikael von Euler, CEO of Axelar.

A total of 101 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC, stage IIIB or IV) were randomized in the AXL-003 study (see ‘About AXL-003’). The primary objective was to compare the rate of progression-free survival (PFS) at 12 weeks between the group of patients treated with AXL1717 and the docetaxel group. The 12-week PFS rate for the 99 patients who received study medication was 25.9% in the AXL1717 group and 39.0% in the docetaxel group, the difference was not statistically significant (p=0.19).

The main secondary endpoints were PFS and overall survival (OS), yielding the results shown in the table below. Neither of these endpoints showed a statistically confirmed difference between the two treatment groups for all patients or for any of the histological subgroups. The OS results for patients with adenocarcinoma suggested a more favorable outcome following treatment with AXL1717 compared with the outcome for patients with squamous cell carcinoma.

“AXL1717 has been tested in more than 140 patients to date and data suggest that it has a clinical effect in one of the most deadly cancers. Based on the clinical data package, Axelar is now planning future studies in parallel with ongoing partner discussions”, says Torbjörn Bjerke, CEO of Karolinska Development.

The main side effects in both groups were hematological; mainly reduced neutrophil granulocyte counts in blood (neutropenia): 22.4% of the AXL1717 treated patients reported at least one event of CTCAE (Common Terminology Criteria for Adverse Events) grade 3/4 neutropenia compared with 53.7% of the docetaxel treated patients. Some of the early neutropenic episodes in the AXL1717 group developed into serious events and some of these were fatal. The neutropenia side effects were managed with a dose reduction of AXL1717 coupled with increased supervision of the patients.

“There is increasing evidence that AXL1717, in addition to the IGF-1R pathway inhibition, also suppress tumor cell division by arresting cells in mitosis through a non-IGF-1R dependent mechanism. This proposed additional mechanism of action would explain the differences in efficacy and side effect profile compared with other substances inhibiting the IGF-1R pathway”, says Mikael von Euler.

Axelar is planning to present more data from AXL-003 at scientific meetings during 2014.

“Although we did not see an improved outcome for the patients with NSCLC that received AXL1717 compared to patients receiving docetaxel, we are still encouraged by the results from AXL-003. The clinical data taken together with new data on a second mechanism of action suggest that AXL1717 has the potential to be developed for patients that have relapsed after treatment with docetaxel in this difficult to treat indication”, says Mikael von Euler, CEO of Axelar.

A total of 101 patients with locally advanced or metastatic non-small cell lung cancer (NSCLC, stage IIIB or IV) were randomized in the AXL-003 study (see ‘About AXL-003’). The primary objective was to compare the rate of progression-free survival (PFS) at 12 weeks between the group of patients treated with AXL1717 and the docetaxel group. The 12-week PFS rate for the 99 patients who received study medication was 25.9% in the AXL1717 group and 39.0% in the docetaxel group, the difference was not statistically significant (p=0.19).

The main secondary endpoints were PFS and overall survival (OS), yielding the results shown in the table below. Neither of these endpoints showed a statistically confirmed difference between the two treatment groups for all patients or for any of the histological subgroups. The OS results for patients with adenocarcinoma suggested a more favorable outcome following treatment with AXL1717 compared with the outcome for patients with squamous cell carcinoma.

“AXL1717 has been tested in more than 140 patients to date and data suggest that it has a clinical effect in one of the most deadly cancers. Based on the clinical data package, Axelar is now planning future studies in parallel with ongoing partner discussions”, says Torbjörn Bjerke, CEO of Karolinska Development.

The main side effects in both groups were hematological; mainly reduced neutrophil granulocyte counts in blood (neutropenia): 22.4% of the AXL1717 treated patients reported at least one event of CTCAE (Common Terminology Criteria for Adverse Events) grade 3/4 neutropenia compared with 53.7% of the docetaxel treated patients. Some of the early neutropenic episodes in the AXL1717 group developed into serious events and some of these were fatal. The neutropenia side effects were managed with a dose reduction of AXL1717 coupled with increased supervision of the patients.

“There is increasing evidence that AXL1717, in addition to the IGF-1R pathway inhibition, also suppress tumor cell division by arresting cells in mitosis through a non-IGF-1R dependent mechanism. This proposed additional mechanism of action would explain the differences in efficacy and side effect profile compared with other substances inhibiting the IGF-1R pathway”, says Mikael von Euler.

Axelar is planning to present more data from AXL-003 at scientific meetings during 2014.

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