
Crucially, while Immutep expects that patient recruitment will continue into the first half of calendar year 2019, the event drivenread-out (152 events needed) of first Progression-Free Survival (PFS) data remains expected in the second half of calendar year 2019. The expected APIAC PFS readout therefore remains overall on track.
TACTI-mel
As reported in August 2018, the Company’s TACTI-mel Phase I study is fully recruited (24 patients) and final data could be expected in calendar 2019. The TACTI-mel (Two ACTive Immunotherapeutics in melanoma) trial is evaluating the combination of efti and KEYTRUDA® (pembrolizumab) in unresectable or metastatic melanoma patients.
TACTI-mel interim data will be presented at different industry conferences, as previously announced. Most notably, the Company will have a poster and for the first time an oral presentation at SITC, updating safety and efficacy data from part A of the trial (18 patients).
INSIGHT (IKF)
Immutep’s partner, the Institute of Clinical Cancer Research, Krankenhaus Nordwest GmbH in Frankfurt, Germany (“IKF”), has reported that patient recruitment for the trial is ongoing, with a total of 10 patients recruited to the trial. A status update is planned to be presented in the coming months.
Immutep and IKF have also commenced preparations for the necessary regulatory submissions to enable the commencement of patient recruitment for the Phase I clinical trial being conducted under Immutep’s new clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc., as announced in September 2018. See below for further updates on this collaboration.
Business Development Update
New collaboration with Merck KGaA, Darmstadt, Germany and Pfizer Inc.
As announced in September 2018, the Company entered into a clinical trial collaboration and supply agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate the combination of Immutep’s efti with avelumab*, a humananti-PD-L1 antibody, in patients with advanced solid malignancies.
The planned clinical evaluation will be executed as an amendment to the existing INSIGHT Phase I clinical trial and Immutep reports that it will involve the recruitment of 12 patients with different solid tumors. The trial will evaluate the safety, tolerability and recommended Phase II dose of efti when combined with avelumab.
IKF will be the sponsor of the clinical trial and it will be conducted under the existing protocol of the ongoing INSIGHT study. Prof. Dr. Salah-Eddin Al-Batran, the lead investigator of INSIGHT and member of Immutep’s clinical advisory board, will also be the lead investigator of the trial.