AbbVie's etentamig succeeds in Phase 3 trial for multiple myeloma

AbbVie announced positive Phase 3 results for its multiple myeloma drug etentamig, which reduced the risk of disease progression or death by 60% in the CERVINO trial. Etentamig demonstrated a 74% objective response rate and a favorable safety profile, with a 28.3% rate of cytokine release syndrome. Analysts and investigators suggest etentamig's monthly dosing schedule and low toxicity could expand treatment access to community oncology centers, positioning it to compete with established therapies.

Etentamig Phase 3 trial results

• ▪Independent trial monitors unblinded the Phase 3 CERVINO trial of AbbVie's etentamig at a pre-planned interim checkpoint due to a significant difference between the treatment and control groups, leaving 393 people evaluable.
• ▪The Phase 3 CERVINO trial enrolled 421 patients with relapsed or refractory multiple myeloma who had undergone at least two prior lines of therapy.
• ▪AbbVie's investigational drug etentamig achieved an objective response rate of 74% in the Phase 3 CERVINO trial, compared to 45.7% in the control arm receiving standard therapies.
• ▪In the Phase 3 CERVINO trial, AbbVie's investigational drug etentamig reduced the risk of disease progression or death by 60% compared to standard therapies in patients with relapsed or refractory multiple myeloma.

Cytokine release syndrome rates

• ▪AbbVie reported a 28.3% rate of cytokine release syndrome in the etentamig treatment group during the Phase 3 CERVINO trial, with most cases being grade 1 and none reaching grade 3 or above.
• ▪Only one patient treated with AbbVie's etentamig in the Phase 3 CERVINO trial developed grade 1 immune effector cell-associated neurotoxicity syndrome.
• ▪The 28% cytokine release syndrome rate for AbbVie's etentamig is lower than the rates reported in clinical trials for rival drugs, including Johnson & Johnson's Tecvayli at nearly 75%, Pfizer's Elrexfio at more than 50%, and Regeneron's Lynozyfic at 46%.

Bispecific antibody mechanism

• ▪AbbVie's etentamig is an investigational anti-BCMA bispecific T cell engager that simultaneously binds to diseased tumor cells and T cells to trigger an immune response against multiple myeloma.
• ▪Unlike CAR-T therapies that require extensive re-engineering of a patient's own cells, bispecific antibodies like AbbVie's etentamig are dual-acting drugs that do not require cell engineering but still carry risks of cytokine release syndrome and neurotoxicity.

Monthly dosing schedule advantage

• ▪Competitor multiple myeloma drugs Johnson & Johnson's Tecvayli and Regeneron's Lynozyfic require two step-up doses and weekly or biweekly injections before transitioning to a monthly schedule.
• ▪AbbVie's etentamig utilizes a single step-up dose followed by dosing once every four weeks.

Community oncology center access

• ▪Atrium Health Levine Cancer Institute investigator Peter Voorhees stated that AbbVie's etentamig has the potential to expand patient access into outpatient and community-based settings.
• ▪The low rates of cytokine release syndrome and neurotoxicity associated with AbbVie's etentamig could reduce the need for post-treatment patient monitoring, enabling its use in community oncology centers.

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