On Thursday, Immutep Limited (NASDAQ:IMMP) released data from the INSIGHT-003 Phase 1 trial of eftilagimod alpha (efti) in combination with Merck & Co Inc's (NYSE:MRK) Keytruda (pembrolizumab) and chemotherapy for first-line treatment of metastatic non-squamous non-small cell lung cancer (1L NSCLC) patients.
The survival data as of data cutoff of Oct. 15 from the triple combination therapy in patients irrespective of PD-L1 expression with a minimum followup of 22 months (N=21) shows:
- Median Overall Survival (OS) of 32.9 months.
- Median Progression-Free Survival (PFS) of 12.7 months.
- 24-month Overall Survival (OS) of 81.0%.
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The company compares the data with the 22.0-month median OS, 9.0-month median PFS, and 24-month OS rate of 45.5% from a registrational trial of anti-PD-1 and doublet chemotherapy in non-squamous 1L NSCLC regardless of PD-L1 expression.
Marc Voigt, CEO of Immutep, said, "The overall survival and progression-free survival data from this mature cohort of patients in INSIGHT-003 with nearly a 2-year minimum followup exceeds our expectations."
Data from all evaluable patients to date (N=40) demonstrates significant improvement in Overall Response Rate (ORR) across all levels of PD-L1 expression compared to historical control:
- 75.0% ORR versus 62.1% ORR in patients with high PD-L1 expression.
- 58.8% ORR versus 49.2% ORR in patients with low PD-L1 expression.
- 47.4% ORR versus 32.3% ORR in patients with negative PD-L1.
- In this all-comer PD-L1 trial, the 55.0% ORR and 87.5% Disease Control Rate (DCR) are from the following breakdown of patients by PD-L1 expression: high PD-L1 expression (N=4), low PD-L1 expression (N=17), and negative PD-L1 (N=19).
- Compared to the general 1L NSCLC patient population, each of these PD-L1 levels represents roughly one-third, INSIGHT-003 is biased towards low and negative PD-L1 patients who are typically less responsive to anti-PD-1 therapy.
- In these patients with low and negative PD-L1 expression (36 of 40 patients), the triple combination achieved a 52.8% ORR and 86.1% DCR.
INSIGHT-003, a multi-centre study led by the Frankfurt Institute of Clinical Cancer Research IKF, is nearing completion of patient enrolment.
Additional data updates from this trial are expected in 2025 and beyond.
Price Action: IMMP stock is up 9.6% at $2.05 at last check Thursday.
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