Early Data Indicates Potential of Arcellx and Gilead's Cancer Cell Treatment

Early Data Indicates Potential of Arcellx and Gilead’s Cancer Cell Treatment

Dive Brief:

  • A cancer cell therapy created by Arcellx in collaboration with Gilead Sciences has successfully reduced or eliminated multiple myeloma symptoms in 95% of individuals in advanced stages of the disease, as reported by the companies on Monday. The results came from trial participants whose condition worsened following prior treatments, showing favorable comparison to the primary multiple myeloma cell therapy, Carvykti from Johnson & Johnson and Legend Biotech.
  • So far, none of the trial participants using the Arcellx cell therapy have reported movement disorders linked to nerve damage, a significant side effect that has raised concerns among healthcare providers managing multiple myeloma. A cell therapy that is both effective and poses fewer risks than Carvykti could be more appealing to patients and healthcare professionals, as per analysts’ insights.
  • This information was part of an abstract presentation planned for the upcoming American Society of Hematology annual meeting in December. Additionally, the companies have shared findings from a smaller Phase 1 trial involving participants with early-stage multiple myeloma.

Dive Insight:

Carvykti is positioned behind Bristol Myers Squibb and 2Seventy bio’s Abecma in the treatment landscape. Similar to Abecma, it is a CAR-T therapy aimed at a specific protein, BCMA, commonly present on malignant multiple myeloma cells. Carvykti has gained significant ground, now approved for use post just one line of therapy, while Abecma requires two prior treatments for eligibility.

These CAR-T therapies are created from the patients’ own immune cells and are formulated to recognize and attack cells that express BCMA. However, their production can be intricate and they pose challenges for recipients, such as necessary preparatory treatments and various immune-related side effects. In many instances, patients must remain at or near specialized medical facilities for an extended time.

A notable side effect associated with these therapies is parkinsonism, which was reported in eight out of 285 participants who received Carvykti in critical clinical studies. As a result, clinicians continue to explore newer experimental treatments that might present fewer risks related to this adverse effect.

Data from Arcellx and Gilead, pertaining to their therapy known as anitocabtagene autoleucel or anito-cel, were showcased from two distinct trials. One of these was a Phase 2 study aimed at backing regulatory approval for patients whose multiple myeloma has deteriorated after four lines of therapy, alongside a Phase 1 study for those treated with one to three lines.

In both investigations, researchers reported no incidents of parkinsonism or similar nervous system-related side effects.

The Phase 2 trial demonstrated that diseased cells diminished or vanished entirely in 95% of participants receiving anito-cel. Additionally, three-fifths experienced a complete or near-total elimination of malignant cells. In a comparable cohort, Carvykti resulted in a 98% overall response rate and an 80% complete response rate, although a direct comparison is not feasible as the two have not been evaluated in a head-to-head trial.

Opinions among Wall Street analysts varied regarding these findings. Stifel analyst Benjamin Burnett, who tracks Arcellx, noted that anito-cel “checks the box” in terms of demonstrated similar efficacy with an improved side effect profile. However, he pointed out a concern regarding one participant’s death due to a hemorrhage.

On the other hand, RBC Capital Markets analyst Leonid Timashev, who covers J&J partner Legend, emphasized anito-cel’s efficacy results. He remarked, “Our assessment from the totality of the efficacy data is that Carvykti remains the most effective BCMA cell-therapy, and given that efficacy is a vital concern for physicians, we believe Carvykti will likely maintain its status as the preferred CAR-T option,” he noted.

Following the announcement, Arcellx shares experienced a 6% decline on Tuesday morning, while Gilead’s stock remained stable.