This section highlights FDA-related milestones and regulatory updates for drugs developed by Lyell Immunopharma (LYEL).
Over the past two years, Lyell Immunopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
IMPT-314, LYL314, and LYL797. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
IMPT-314 - FDA Regulatory Timeline and Events
IMPT-314 is a drug developed by Lyell Immunopharma for the following indication: For the treatment of B-cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- IMPT-314
- Announced Date:
- May 1, 2025
- Indication:
- For the treatment of B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced that an abstract highlighting new clinical data from the Phase 1/2 trial of LYL314 (formerly IMPT-314) in large B-cell lymphoma will be presented as an oral presentation at the International Conference on Malignant Lymphoma (ICML) 2025 taking place in Lugano, Switzerland June 17-21, 2025.
AI Summary
Lyell Immunopharma, Inc. announced that new clinical data from its Phase 1/2 trial of LYL314 in large B-cell lymphoma will be presented as an oral session at the International Conference on Malignant Lymphoma (ICML) 2025. The presentation is scheduled for June 18, 2025, at ICML in Lugano, Switzerland. LYL314 is a dual-targeting CD19/CD20 CAR T-cell product candidate designed to treat aggressive large B-cell lymphoma, especially in patients who have not responded well to previous treatments.
This new clinical data emphasizes LYL314's potential to produce high rates of durable complete responses in patients with relapsed or refractory large B-cell lymphoma. The findings could offer valuable insights into advancing next-generation CAR T-cell therapies and improving treatment options for patients battling this aggressive form of cancer.
Read Announcement- Drug:
- IMPT-314
- Announced Date:
- December 9, 2024
- Indication:
- For the treatment of B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced initial positive clinical data from the multi-center Phase 1-2 study of IMPT-314 in patients with large B-cell lymphoma that is being presented at the 66th American Society of Hematology (ASH) Annual Meeting.
AI Summary
Lyell Immunopharma, Inc. has revealed initial positive data from its multi-center Phase 1-2 trial of IMPT-314 in patients with large B-cell lymphoma. The study, presented at the 66th American Society of Hematology Annual Meeting, focused on heavily pretreated, CAR T-cell naïve patients. IMPT-314 is a dual-targeting CAR T-cell therapy designed to target both CD19 and CD20, and early results show a 94% objective response rate and a 71% complete response rate by three months.
The safety profile of IMPT-314 was favorable, with no high-grade cytokine release syndrome reported and only a small percentage experiencing Grade 3 immune effector cell-associated neurotoxicity. Additionally, the treatment demonstrated robust cell expansion and maintained a high proportion of naïve and central memory T cells, which may contribute to durable clinical responses in these patients.
Read Announcement
LYL314 - FDA Regulatory Timeline and Events
LYL314 is a drug developed by Lyell Immunopharma for the following indication: For the Treatment of Aggressive Large B-cell Lymphoma.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYL314
- Announced Date:
- June 17, 2025
- Indication:
- For the Treatment of Aggressive Large B-cell Lymphoma
Announcement
Lyell Immunopharma, Inc. announced positive new clinical data from the multi-center Phase 1/2 trial of LYL314, including data from patients with large B-cell lymphoma (LBCL) treated in the third- or later-line (3L+) setting.
AI Summary
Lyell Immunopharma recently shared promising new clinical data from their multi-center Phase 1/2 trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting. In this group, LYL314 achieved an overall response rate of 88% and a complete response rate of 72%. Notably, 71% of those who reached complete response maintained it for at least six months, indicating durable results. The treatment demonstrated a manageable safety profile suitable for outpatient care, with no instances of severe cytokine release syndrome and low rates of neurotoxicity that resolved quickly.
The company is moving forward with a pivotal single-arm PiNACLE trial in CAR T-naïve patients, and these positive findings underline LYL314’s potential to offer significant benefits for patients with relapsed or refractory large B-cell lymphoma.
Read Announcement
LYL797 - FDA Regulatory Timeline and Events
LYL797 is a drug developed by Lyell Immunopharma for the following indication: Solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- LYL797
- Announced Date:
- June 26, 2024
- Indication:
- Solid tumors
Announcement
Lyell Immunopharma, Inc announced initial clinical and translational data from its Phase 1 trial of LYL797, its first-generation reprogrammed ROR1 CAR T‑cell product candidate enhanced with proprietary anti-exhaustion technology.
AI Summary
Lyell Immunopharma announced promising initial clinical and translational data from its Phase 1 trial of LYL797, a first-generation reprogrammed ROR1 CAR T‑cell product enhanced with proprietary anti‑exhaustion technology. In patients with relapsed/refractory triple‑negative breast cancer, the trial showed a dose‑dependent antitumor response, with a 40% objective response rate and a 60% clinical benefit rate at the highest dose of 150 x 10⁶ CAR T cells. The data revealed that LYL797 not only expanded effectively but also infiltrated solid tumors to kill cancer cells. Importantly, the treatment was generally safe in patients without lung involvement, while pneumonitis was noted in those with lung metastases, which is being managed with steroids. These results underscore the potential of anti‑exhaustion technologies to improve CAR T‑cell therapy outcomes and support further exploration in other ROR1‑positive solid tumors.
Read Announcement
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