Relay Therapeutics (RLAY) Jefferies Global Healthcare Conference 2026 summary

Key data presentations and clinical insights

• Presented three major data sets in HR-positive, HER2-negative breast cancer and vascular anomalies, highlighting an 11-month PFS with an oral regimen in second-line breast cancer, outperforming standard care.

• Early data in third-line breast cancer showed a clean safety profile and strong efficacy, supporting rapid advancement into frontline trials.

• Vascular anomaly data showed a 60% volumetric response rate, far exceeding historical rates, indicating a paradigm shift for underserved patients.

• Ongoing pivotal trials in all three indications are progressing rapidly, with plans to bring new therapies to patients as soon as possible.

Competitive landscape and positioning

• Recent Celcuity data showed an 11-month PFS with a triplet IV regimen, matching the oral regimen's results, suggesting oral options may quickly gain market share due to patient preference.

• No clear benefit was observed for adding CDK4/6 to the triplet, creating prescriber uncertainty between doublet and triplet regimens.

• Confidence remains high in the oral PI3K-alpha/CDK4 combo, supported by external data (e.g., Roche's INAVO120) showing efficacy in frontline settings, despite tolerability challenges with some regimens.

Clinical trial design and future updates

• Frontline trials are powered based on historical PFS data (19–20 months for PIK3CA-mutated patients), with a clinically meaningful improvement defined as a six-month PFS gain.

• Additional triplet data, including dose expansion cohorts, will be disclosed in the first half of next year, with potential for median PFS estimates from over a year of follow-up.

• Tolerability and duration on drug are key metrics, with late-line data showing promising safety profiles expected to translate to frontline settings.