What are the key efficacy and safety data points from the Phase 1/2 study in the 2L setting? | LYEL (Aug 12, 2025) | Candlesense
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What are the key efficacy and safety data points from the Phase 1/2 study in the 2L setting?

Answer

The press release does not disclose any specific efficacy or safety results from the Phase 1/2 study of LYL314 in the second‑line (2L) setting. Lyell only notes that the product is being evaluated in a Phase 1/2 trial for relapsed/refractory large B‑cell lymphoma (LBCL) after first‑line therapy, but no objective response rates, complete‑response (CR) percentages, duration of response (DoR), or safety‑event frequencies (e.g., cytokine‑release syndrome, neurotoxicity) were reported.

Because the data are still pending, the 2L trial remains a near‑term catalyst. Until the company releases the first efficacy read‑out (typically ORR ≥ 70% and CR ≥ 30% are considered “next‑generation” for dual‑targeting CAR‑T) and safety profile (grade ≥ 3 CRS/ICANS ≤ 15% of patients), the market will price the stock on speculation. Traders should watch for a forthcoming data‑release update (likely in the next 4‑6 weeks). A strong efficacy signal combined with a manageable safety profile could trigger a short‑cover rally and upside to the $12‑$14 range, while a modest or safety‑concern‑laden read‑out may keep the stock constrained near its current $9‑$10 level. Until then, a cautious, wait‑for‑data stance is advisable.

Other Questions About This News

What is the company’s partnership or licensing strategy for LYL314 and other pipeline assets? What are the implications of the 3L+ and 2L trial data for market share in the LBLB market? How will the Q2 financial results affect LYEL's stock price in the short term? What are the specific enrollment numbers and projected timelines for the PiNACLE pivotal trial? What is the anticipated regulatory pathway and timeline for FDA approval of LYL314? How does LYL314's dual-targeting CD19/CD20 approach compare to competitor CAR‑T products in efficacy and safety? What are the projected revenues from LYL314 if it reaches commercialization, and how does that compare with existing CAR‑T therapies? What is the company’s cash runway and burn rate, and how much runway remains after the quarter? Did the company provide updated guidance for 2025 revenue, net loss, and cash burn? What are the potential catalysts or risks that could impact the stock price (e.g., trial results, FDA meetings, competitive announcements)? How does the current valuation (PE, price/sales, EV/EBITDA) compare to other late‑stage CAR‑T companies? Are there any upcoming data readouts, conference presentations, or shareholder meetings that could move the stock? How does the sentiment score of 30 align with analyst consensus and market expectations? What is the competitive landscape for dual‑targeting CAR‑T therapies and who are the main rivals? How does Lyell’s financial performance this quarter compare to the same quarter last year? What is the current ownership structure and any recent insider trading activity? What are the potential implications of the trial's single‑arm design for regulatory approval? What is the potential impact of any FDA Fast Track, Breakthrough, or other designations on the timeline? How might the market react to any disclosed adverse events or safety concerns in the trial data?