Posted: 23 October 2023
Immutep Limited (ASX: IMM; NASDAQ: IMMP) (“Immutep” or “the Company”), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, today announces excellent new clinical data from the TACTI-002 / KEYNOTE-798 Phase II trial evaluating eftilagimod alpha (“efti”), a soluble LAG-3 protein and first-in-class MHC Class II agonist, in combination with MSD’s (Merck & Co., Inc., Rahway, NJ., USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab) as first-line treatment for patients with previously untreated unresectable or metastatic non-small cell lung cancer (NSCLC).
The updated TACTI-002 data, with a cut-off date of August 15, 2023 and a median follow up of over 2 years (25.1 months), was presented by Dr. Enric Carcereny, Catalan Institute of Oncology (ICO), Badalona, Spain, during a Mini Oral session (#1312MO) at ESMO Congress 2023 on Saturday, October 21st. Key takeaways from the oral presentation detailing results from efti in combination with KEYTRUDA® for frontline treatment of advanced or metastatic NSCLC in the TACTI-002 Phase II trial1 include:
- Promising Overall Survival (OS), Overall Response Rate (ORR), Progression Free Survival (PFS), and Duration of Response (DOR) are visible across all PD-L1 subgroups (Tumor Proportion Score [TPS] <1%, ≥1%, 1-49%, and ≥50%), which clearly differentiates efti in combination with KEYTRUDA® from other chemo-free immuno-oncology (IO) combinations for first-line treatment of NSCLC.
- A significant overall survival benefit was achieved, with a 35.5-month median Overall Survival (mOS) in patients with TPS ≥1%, 23.4-month mOS in TPS 1-49%, and mOS not yet reached in TPS ≥50%. Notably, the mOS in TPS ≥1% was attained with central assessment of PD-L1 (N=58) and a larger patient group with central + local assessment of PD-L1 (N=71), and the 35.5-month mOS compares very favourably to standard-of-care IO, IO-IO, IO-chemo, and IO-IO-chemo therapies (Table 1).
- Exceptional durability and quality of responses are increasingly evident with strong overall survival (OS) and progression free survival (PFS) rates across patients expressing PD-L1. The 3-year OS rates are 45.6%, 31.0%, and 63.6% in TPS >1%, TPS 1-49%, and TPS >50%, respectively. The 12-month PFS rates are 46.8%, 42.1%, and 55.0% for TPS >1%, TPS 1-49%, and TPS >50%, respectively.
- The entire patient population regardless of PD-L1 expression (N=114) showed encouraging efficacy with 20.2-month mOS, 21.6-month mDoR, and a 36-month OS rate of 36% despite ~75% of patients having negative or low PD-L1 expression.
In NSCLC patients with >1% PD-L1 expression, a key area for efti’s future development where it has FDA Fast Track status, the ORR (48.3%), mPFS (11.2 months), mDOR (24.2 months), and mOS (35.5 months) compare overall favourably to historical results of anti-PD-1 monotherapy, as well as to historical results of approved anti-PD-1 + chemo-containing regimens. Collectively, the breadth of efficacy and safety data from the large number of metastatic NSCLC patients in the Phase II TACTI-002 trial offers compelling evidence of efti’s substantial impact in safely stimulating the patients’ immune response to fight cancer.
Dr. Enric Carcereny stated, “The strong efficacy data across all levels of PD-L1 expression in TACTI-002, especially in PD-L1 low (1-49%) and PD-L1 negative (<1%) patients, differentiates efti in combination with anti-PD-1 from other chemo-free immuno-oncology combinations in the frontline treatment of advanced or metastatic non-small cell lung cancer. Unlike other IO-IO combinations that only work in high PD-L1 expressing patients or IO-chemo combinations that rely on toxic chemotherapy to drive better efficacy, efti is clearly enabling deep, durable responses for patients regardless of PD-L1 expression with a favourable safety profile that’s in line with anti-PD-1 monotherapy.”
Marc Voigt, Immutep CEO stated, “We are extremely pleased to report these excellent overall survival results, the gold standard benchmark within oncology, in patients with metastatic non-small cell lung cancer, and believe these are among the strongest ever delivered in a sizable Phase II clinical trial like TACTI-002 evaluating a dual immuno-oncology approach. The strength of the data positions us well as we continue to plan and prepare for our Phase III trial that we expect to launch next year.”
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