Immutep Reports Improving Results from INSIGHT-004 Trial

Rhea-AI Summary

Immutep Limited (NASDAQ: IMMP) announced interim results from its INSIGHT-004 Phase I clinical trial, presented at ESMO Virtual Congress 2020. The trial evaluated the combination therapy of eftilagimod alpha and avelumab, showing a 41.7% partial response rate in 12 patients, an increase from 33% in previous assessments. The treatment demonstrated promising activity in cancers typically resistant to immune checkpoint inhibitors. Importantly, the therapy was found to be safe and well-tolerated, with no dose-limiting toxicities.

Positive

• 41.7% of patients showed a Partial Response to the combination therapy, up from 33%.
• Encouraging anti-tumour activity in cancers typically resistant to immune checkpoint inhibitors.
• Combination therapy is safe and well tolerated with no dose-limiting toxicities.

Negative

• None.

• 41.7% of patients showed a Partial Response to the combination therapy of eftilagimod alpha and avelumab (previously 33%)
  
• Encouraging early anti-tumour activity signals in a variety of cancer indications not typically sensitive to immune checkpoint inhibitor (ICI) therapy
• Combination of eftilagimod alpha and avelumab continues to be safe and well tolerated       

SYDNEY, Australia, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Immutep Limited (ASX: IMM; NASDAQ: IMMP) is pleased to report further interim data from its ongoing INSIGHT-004 Phase I clinical trial. The data were presented at the ESMO Virtual Congress 2020 on 17 September 2020, CEST (poster ID number 1032P) by trial investigator at Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF), PD Dr. Thorsten Götze.

INSIGHT-004 is evaluating the combination of Immutep’s lead product candidate, eftilagimod alpha (“IMP321” or “efti”) with avelumab (Bavenico), a human anti-PD-L1 antibody, in 12 patients with different solid tumours, primarily gastrointestinal. It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., which are co-developing and co-commercialising avelumab. INSIGHT-004 is the fourth arm (Stratum D) of the investigator-initiated INSIGHT trial which is conducted by IKF in Frankfurt, Germany.

Prof Salah-Eddin Al-Batran, INSIGHT-004 trial investigator and Director of IKF said: “It is encouraging to see the range of patients with different solid cancers that are responding to the combination of efti and avelumab, including PD-L1-negative cervical cancer, squamous anal cell carcinoma and mesothelioma. These tumours are not typically responsive to immune checkpoint therapy and warrant further investigation.”

Results Summary (data cut off 12 June 2020)

• 41.7% of patients (5 / 12) showed a partial response (PR) to the combination therapy according to RECIST 1.1. Previously 33% showed a PR (June 2020).
• Encouraging durable deep responses in PD-L1 negative cancer.

Tumor response – according to RECIST 1.1	Total N (%) Total (N=12)
Complete Response (CR)	0 (0)
Partial Response (PR)	5 (41.7%)
Stable Disease (SD)	1 (8.3%)
Progressive Disease (PD)*	5 (41.7%)
Not Evaluable (NE)**	1 (8.3%)
Objective Response Rate (ORR)	5 (41.7%)
Disease Control Rate (DCR)	6 (50%)

*Includes 2 patients with clinical progression
**Response assessment not yet performed

Safety
Interim results from INSIGHT-004  show that the combination of efti and avelumab is well tolerated with no dose limiting toxicities, building on efti’s strong safety profile to date.

IKF INSIGHT Trial Poster
IKF also presented data from the broader INSIGHT trial at ESMO showing that intratumoral and intraperitoneal administration of efti up to 30 mg displayed signals of clinical and cytokine responses. Both IKF posters are appended below and are available on the Company’s website at https://www.immutep.com/investors-media/presentations.html.

About INSIGHT-004
INSIGHT-004 is the fourth arm of the investigator-initiated INSIGHT trial which is being conducted by the Institute of Clinical Cancer Research IKF at Krankenhaus Nordwest in Frankfurt. It is being conducted under Immutep’s collaboration with Merck KGaA, Darmstadt, Germany, and Pfizer Inc., and is evaluating the safety, tolerability and recommended Phase II dose of efti when given in combination with avelumab. It is the first combination trial of an approved and marketed anti-PD-L1 drug and efti.

Patients in cohort 1 receive 6mg doses of efti every two weeks with the standard dose of avelumab (800mg every two weeks), while patients in cohort 2 receive a higher dose of efti, 30mg, with avelumab.

Further information can be found on the Company’s website www.immutep.com or by contacting:

Australian Investors/Media:
Catherine Strong, Citadel-MAGNUS
+61 (0)406 759 268; cstrong@citadelmagnus.com

U.S. Media:
Tim McCarthy, LifeSci Advisors
+1 (212) 915.2564; tim@lifesciadvisors.com

FAQ

What are the interim results from Immutep's INSIGHT-004 trial?

The interim results revealed a 41.7% partial response rate in patients treated with eftilagimod alpha and avelumab.

What percentage of patients responded to the combination therapy in the INSIGHT-004 trial?

41.7% of patients showed a partial response to the combination therapy.

What is the safety profile of the eftilagimod alpha and avelumab combination therapy?

The combination therapy has been reported as safe and well tolerated, with no dose-limiting toxicities.

How does the response rate from INSIGHT-004 compare to previous results?

The response rate increased from 33% in previous assessments to 41.7% in the latest results.

In which types of cancer was the combination therapy tested?

The combination was tested in various solid tumours, including PD-L1-negative cervical cancer and squamous anal cell carcinoma.