Allogene Therapeutics, a leading biotech company, has made a strategic decision to discontinue its plans to target one of its allogeneic CAR-T therapies for leukemia, citing the emergence of new treatment options in the market. The company's focus will now shift to advancing its other promising CAR-T programs, including a potential first-line consolidation therapy for large B-cell lymphoma (LBCL) and a CD70-targeting therapy for renal cell carcinoma.

Navigating the Competitive Landscape in Leukemia Treatment

Allogene's Withdrawal from the CLL Segment

Allogene had been enrolling patients in a phase 1 trial of a CD19 CAR-T cell therapy called cemacabtagene ansegedleucel (cema-cel) for relapsed or refractory chronic lymphocytic leukemia (CLL) in patients previously treated with BTKi and BCL2i therapies. However, the company has now decided to discontinue enrollment in this trial, citing slower-than-anticipated enrollment due to the emergence of new alternative treatment options.While Allogene did not explicitly name the specific competitors that contributed to this decision, analysts have pointed to the recent approval of Bristol Myers Squibb's CD19 CAR-T therapy, Breyanzi, for CLL as a potential factor. Breyanzi became the first CAR-T therapy to enter the CLL market, where BTK inhibitors are the standard first-line treatments.

The Evolving CLL Treatment Landscape

The CLL treatment landscape has seen significant advancements in recent years, with the approval of new therapies like Eli Lilly's BTK inhibitor, Jaypirca, which was approved in December 2023 for CLL patients who have already tried another BTK inhibitor and a BCL-2 inhibitor. These new treatment options have likely contributed to the slower-than-expected enrollment in Allogene's CLL trial.

Allogene's Shift in Focus

Despite the discontinuation of the CLL program, Allogene remains committed to advancing its other CAR-T therapies. The company will now focus its resources on the development of cema-cel as a potential first-line consolidation therapy in LBCL, where it is already undergoing a phase 2 trial. Additionally, Allogene's pipeline includes a CD70-targeting CAR-T called ALLO-316, which recently showed promising results in a phase 1 renal cell carcinoma trial, as well as a CD19/CD70 dual CAR-T called ALLO-329, which is in preclinical development for autoimmune diseases.

Analysts' Perspective

Analysts at William Blair have expressed understanding for Allogene's decision, noting that the discontinuation of the CLL program was not entirely unexpected given the delays in initial data and the lack of mention in the company's recent earnings release. The analysts view Allogene's decision to focus on the advancement of cema-cel, ALLO-316, and ALLO-329 as a prudent move, allowing the company to allocate its current cash resources ($403.4 million as of September 30) more effectively.

Potential for Cema-cel in LBCL

In the LBCL market, analysts believe that cema-cel has the potential to "leapfrog" other autologous and allogeneic CD19 CAR-T therapies, remain competitive for longer, and expand the total addressable market. This optimism is based on the therapy's potential to be a first-line consolidation treatment, which could provide a significant advantage over existing options.

Allogene's Diversified Pipeline

Allogene's decision to focus on its other CAR-T programs, such as ALLO-316 and ALLO-329, demonstrates the company's commitment to diversifying its pipeline and exploring the potential of its technology in various cancer and autoimmune indications. This strategic shift aligns with the company's goal of delivering innovative and effective treatments to patients in need.