Encouraging Efficacy in Tough Patient Group (Image Credits: Pixabay)
For patients battling PIK3CA-mutated, hormone receptor-positive, HER2-negative metastatic breast cancer, new clinical results offered a glimpse of hope. Relay Therapeutics disclosed early data from its ReDiscover trial on a triplet combination featuring zovegalisib, atirmociclib, and fulvestrant.[1][2] The findings highlighted strong efficacy in heavily pretreated individuals, prompting analysts to reassess the company’s prospects in this challenging field.
Encouraging Efficacy in Tough Patient Group
The data came from the dose-finding portion of the ongoing Phase 1/2 ReDiscover study. As of the April 13 cutoff date, researchers evaluated 62 patients at or below the potential Phase 3 dose levels. These participants represented a difficult population: all had received prior CDK4/6 inhibitors and at least one endocrine therapy, with a median of two prior metastatic treatments. Nearly two-thirds harbored visceral disease, and almost half were pre-diabetic.[1]
Among 34 patients with measurable disease, the objective response rate reached 44%. Tumor reductions occurred in 85% of these cases. With a median follow-up of 7.4 months, 77% of the 62 patients remained on treatment. Progression-free survival data had not yet matured sufficiently for median estimates. The results held steady across kinase and non-kinase PIK3CA mutations.[1]
Favorable Safety Profile Eases Development Path
Safety stood out as a key strength. Only 3% of patients discontinued zovegalisib due to treatment-related adverse events, and 10% required dose reductions. Grade 3 or higher treatment-related adverse events affected 40% of participants, primarily neutropenia, with no cases of febrile neutropenia. Notably, no instances of grade 3 hyperglycemia emerged, even among pre-diabetic patients.[1]
Don Bergstrom, Relay’s president of research and development, emphasized the combination’s potential. He described it as a candidate for a well-tolerated, all-oral regimen suitable for frontline use. The profile aligned with prior reports on the individual components, supporting further advancement.[1]
Analysts Respond with Adjusted Forecasts
Wall Street took notice quickly. Raymond James lifted its price target on Relay Therapeutics (NASDAQ: RLAY) to $23 from $19 while maintaining a Strong Buy rating. The firm cited the data’s alignment with expectations, a favorable safety profile, and opportunities for frontline expansion in PIK3CA-mutated cases.[2]
Other firms echoed optimism in recent notes. H.C. Wainwright raised its target to $19, Guggenheim to $22, and Citizens to $17. Oppenheimer held its Outperform rating with a $14 target. Consensus estimates now point to around $18, suggesting upside from recent levels near $15.[2]
| Firm | Recent Price Target | Rating |
|---|---|---|
| Raymond James | $23 | Strong Buy |
| Guggenheim | $22 | Buy |
| H.C. Wainwright | $19 | Buy |
| Citizens | $17 | Market Outperform |
| Oppenheimer | $14 | Outperform |
Charting the Path to Phase 3 Trials
Relay plans a randomized Phase 3 trial in frontline, endocrine-sensitive patients. The experimental arm will test zovegalisib plus atirmociclib and an aromatase inhibitor against a CDK4/6 inhibitor plus aromatase inhibitor. Primary focus remains on progression-free survival, with overall survival as a secondary measure. Initiation could occur in early 2027, pending regulatory input.[1]
- Supply deal secured with Pfizer for atirmociclib and palbociclib.
- Ongoing expansion cohorts in ReDiscover.
- Separate Phase 3 ReDiscover-2 trial in second-line breast cancer, backed by FDA Breakthrough Therapy Designation.
- Upcoming data presentation on zovegalisib in vascular anomalies at ISSVA 2026.
These developments underscore Relay’s momentum in precision oncology. Investors eye the stock’s trajectory as the company navigates regulatory discussions and builds toward pivotal readouts. For shareholders and patients alike, the triplet’s promise carries weight in a market hungry for tolerable, effective options.