IPRO Response Rate detected treatment effects missed by ORR, eleven months before primary PFS readout and 26 months before final OS readout in a post hoc analysis.
TORONTO--(BUSINESS WIRE)--Altis Labs, Inc. (“Altis”), the AI endpoint company accelerating clinical trials, today announced findings from an independent post-hoc analysis evaluating its AI-powered imaging endpoint, IPRO, in the MARIPOSA Phase 3 trial.1 The findings, which were presented at the World Conference on Lung Cancer (WCLC) 2026 in Seoul, Republic of Korea, show that Altis’ IPRO Response Rate detected an early, notable treatment effect, while RECIST-based objective response rate (ORR) failed to anticipate the investigational treatment’s 12+ month median overall survival (OS) benefit.
IPRO Response Rate provides early efficacy signal in EGFR-mutated NSCLC
In a post-hoc analysis performed by the trial sponsor, IPRO demonstrated its value as an early endpoint in the trial, which compared treatments in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). The IPRO AI model automatically analyzed approximately 10,000 radiology scans, generating prognostic outcome measures for each patient at baseline and on-treatment assessments. IPRO Response was defined as a ≥50% improvement in the IPRO-α score relative to baseline, and the treatment effect was estimated as the IPRO Response Rate ratio for the investigational treatment versus control arm treatment at landmark early imaging assessments.
Key findings include:
- IPRO Response Rate favored the investigational treatment beginning at Week 16 (IPRO Response Rate Ratio, 1.33; 95% CI, 1.03-1.71) and throughout subsequent time points, while ORR failed to anticipate the significant OS benefit throughout.
- When evaluating pooled, patient-level IPRO trajectories over time, IPRO deterioration was consistently associated with OS detriment, while IPRO improvement was consistently associated with OS benefit.
- IPRO scores for the entire trial were generated automatically from routinely acquired CT imaging, providing an objective, reproducible measure of efficacy.
“This readout proves that AI can anticipate meaningful clinical benefit that traditional imaging endpoints like ORR may fail to detect,” said Felix Baldauf-Lenschen, Founder and CEO of Altis Labs. “We’re focused on supporting our biopharma partners and ultimately patients by bringing this level of precision into clinical trials so that efficacy can be detected earlier.”
The results were presented on September 13th, 2026, at WCLC, Abstract/Poster: P1.046: IPRO-a Response Rate as a Potential Early Endpoint for Overall Survival in MARIPOSA, a Phase 3 Trial in EGFR-Mutated NSCLC. Abstract can be viewed at: https://cattendee.abstractsonline.com/meeting/21487/Presentation/3918
About IPRO
IPRO is a fully automated AI system that predicts patient survival directly from the CT scans already acquired in clinical trials. Rather than automating RECIST, IPRO goes beyond measuring target lesion size by analyzing the entire three-dimensional scan to quantify thousands of prognostic imaging biomarkers spanning tumor burden, body composition, and organ health that contribute to multifactorial survival outcomes. At the patient-level, improvements in IPRO (i.e. IPRO Response) are associated with survival benefit, while IPRO deterioration is associated with survival detriment. Clinical trial sponsors use IPRO Response Rate as a novel, survival-linked endpoint to detect early efficacy signals and navigate go/no-go decisions with greater confidence.
About Non-Small Cell Lung Cancer (NSCLC)
NSCLC accounts for up to 85% of all lung cancer cases worldwide and is the leading cause of cancer death. Epidermal growth factor receptor (EGFR) alterations represent one of the most common driver mutations, found in 10% to 15% of Western patients and up to 40% to 50% of Asian patients with adenocarcinoma histology. Despite advances in targeted therapies, the five-year survival rate for patients with advanced EGFR-mutated NSCLC treated with standard-of-care remains under 20%.
About Altis Labs
Altis Labs is the AI endpoint company accelerating clinical trials. Altis was founded on the premise that AI's greatest potential lies in generating better evidence, faster. In close partnership with leading cancer centers, Altis has trained a prognostic AI model, IPRO, on the industry’s largest multimodal oncology database comprising longitudinal imaging, molecular, clinical, and outcomes data spanning over 500,000 patient years. Top 20 biopharma companies use IPRO to more confidently analyze data from phase 1-4 clinical trials so that they can bring the most effective novel treatments to patients sooner.
For more information, visit www.altislabs.com, follow @AltisLabs on social media, or email info@altislabs.com.
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1 | Cho BC, Lu S, Felip E, et al. Amivantamab plus Lazertinib in Previously Untreated EGFR-Mutated Advanced NSCLC. N Engl J Med. 2024;391(7):585-598. doi:10.1056/NEJMoa2403614 | |
Contacts
Altis Labs, Inc.
info@altislabs.com
Colin Sanford
colin@bioscribe.com
