Lyell Shares Surge on Impressive Lymphoma Drug Trial Results
Company reports 93% response rate for its Ronde-Cel therapy at the prestigious ASH annual meeting, positioning it as a strong future contender in a competitive cancer market.
Lyell Immunopharma (NASDAQ: LYEL) saw its shares climb near a 52-week high after the clinical-stage biotechnology firm presented highly encouraging data for its experimental T-cell therapy, Ronde-Cel, in patients with an aggressive form of blood cancer.
The results, unveiled at the 67th American Society of Hematology (ASH) Annual Meeting, showed the treatment produced a 93% overall response rate and a 76% complete response rate in heavily pre-treated patients with relapsed or refractory large B-cell lymphoma (LBCL). The data represents a significant milestone for Lyell as it seeks to establish a foothold in the competitive CAR T-cell therapy landscape.
According to the company's announcement on Sunday, the study focused on patients in a third-line or later setting, a population with limited treatment options. Beyond the high initial response rates, the data pointed to notable durability. Among patients who achieved a complete response, 72% remained in remission at six months or longer, with a median progression-free survival of 18 months.
Investors reacted positively to the news from the ASH meeting, which is considered the premier global event for hematology research. Lyell's stock, trading at $25.25, is now approaching its yearly high of $25.74, reflecting growing optimism about Ronde-Cel's potential. The company, based in South San Francisco, has a market capitalization of approximately $536 million.
"These data... showing high rates of durable complete responses along with a manageable safety profile in patients with high-risk large B-cell lymphoma represent the potential of ronde-cel to improve patient outcomes," commented Dr. Sarah M. Larson, a lead investigator on the trial and an Associate Professor at the David Geffen School of Medicine at UCLA.
The treatment landscape for LBCL is crowded, featuring established CAR T-cell therapies from major pharmaceutical players like Gilead's Yescarta and Novartis's Kymriah. As noted by research presented at the same ASH conference, these existing therapies continue to show consistent safety and efficacy. To gain market share, new entrants like Lyell must demonstrate not just efficacy but also a superior or more manageable safety profile.
On this front, Lyell's data was promising. The company reported no instances of high-grade cytokine release syndrome (CRS), a common and potentially dangerous side effect of T-cell therapies. Furthermore, severe neurotoxicity, another significant concern, was observed in only one patient following a prophylactic treatment. This manageable safety profile could allow for outpatient administration, a key logistical and cost advantage.
Lyell is now advancing Ronde-Cel into two pivotal trials, including what it describes as a first-of-its-kind head-to-head study against existing approved CAR T-cell therapies. The outcomes of these trials will be critical in determining the therapy's ultimate place in the clinical setting.
Wall Street analysts have set an average 12-month price target of $19.00 on Lyell's stock, though these targets may see revisions following the strong data presentation. The company's progress offers a potential new option for patients who have exhausted other treatments and marks a critical step forward for the clinical-stage firm as it moves toward potential commercialization.