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Roche's Itovebi Approval Boosts Relay Therapeutics Following Positive Trial Data

• The FDA approved Roche's Itovebi (inavolisib) in combination with Ibrance and Faslodex for HR+, HER2- advanced or metastatic breast cancer with PIK3CA mutation. • The approval was based on the Phase 3 INAVO120 trial, which showed a 57% reduction in disease progression or death compared to Ibrance and Faslodex alone. • Relay Therapeutics' stock is influenced by this approval, with analysts maintaining positive ratings due to the inclusion of Relay's drug candidate in the Roche therapy. • The combination therapy demonstrated a significantly higher objective response rate (58.4%) compared to the control group (25%) in the INAVO120 trial.

The FDA has approved Roche's Itovebi (inavolisib) for treating HR+, HER2- advanced or metastatic breast cancer with PIK3CA mutations, significantly impacting Relay Therapeutics. This approval follows the Phase 3 INAVO120 trial, which demonstrated a substantial reduction in the risk of disease progression or death when Itovebi was combined with Ibrance (palbociclib) and Faslodex (fulvestrant).

INAVO120 Trial Results

The INAVO120 trial compared the Itovebi combination therapy against Ibrance and Faslodex alone. The results, presented at the San Antonio Breast Cancer Symposium (SABCS) in 2023, revealed a 57% reduction in the risk of disease worsening or death for the combination therapy group. This translated to a median progression-free survival (PFS) of 15.0 months, compared to 7.3 months for the control group. The analysis also indicated a favorable overall survival (OS) rate with a stratified hazard ratio (HR) of 0.64.
The treatment combination also resulted in a 58.4% objective response rate (ORR), significantly higher than the 25% ORR observed with the control regimen. The median duration of response (mDOR) also favored the combination therapy, at 18.4 months versus 9.6 months for the control.

Safety Profile

While the combination therapy was associated with higher incidences of certain side effects such as stomatitis, hyperglycemia, and diarrhea, the majority of patients were able to continue treatment with dose adjustments or interruptions. Only 6.8% of patients discontinued treatment due to adverse events (AEs).

Analyst Perspectives on Relay Therapeutics

Following the FDA's approval of Roche's treatment, H.C. Wainwright maintained its Buy rating on Relay Therapeutics (NASDAQ:RLAY) shares, with a steady price target of $19.00. The firm's endorsement reflects confidence in Relay Therapeutics' position, as the approved treatment includes Relay's drug candidate. Relay Therapeutics' share value is anticipated to be influenced by the clinical advancements and regulatory milestones achieved by its partnered therapies in the oncology space.

Relay Therapeutics' Other Developments

Relay Therapeutics recently reported promising results from its Phase 1 ReDiscover trial, showing a 33.3% objective response rate and a median progression-free survival of 9.2 months. This led to adjustments in outlooks from several analyst firms. H.C. Wainwright raised its price target for Relay Therapeutics to $19.00 while maintaining a Buy rating.
Stifel maintained its Buy rating with a steady price target of $28.00. Jefferies upgraded Relay Therapeutics stock from Hold to Buy and increased the price target to $16.00. However, Oppenheimer downgraded their rating from Outperform to Perform due to concerns about the selectivity profile of RLY-2608.
Relay Therapeutics also initiated a $200 million underwritten public offering of its common stock. The company reported a cash position of approximately $688 million as of the second quarter of 2024, expected to fund operations into 2026.
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Reference News

[1]
Relay Therapeutics stock holds price target on FDA approval - Investing.com UK
uk.investing.com · Oct 14, 2024

H.C. Wainwright maintains Buy rating on Relay Therapeutics (NASDAQ:RLAY) with $19.00 price target, following FDA approva...

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