'Elahere' launches in KOR…AbbVie's ADC success

First-in-class Antibody-Drug Conjugate (ADC) in ovarian cancer…improved key endpoints

Also successfully commercialized c-MET-targeting 'Emrelis' in non-small cell lung cancer (NSCLC)

New ADC drug 'Elahere'

AbbVie is rapidly expanding its oncology portfolio with a series of successful new Antibody-Drug Conjugate (ADC) commercializations.

AbbVie secured the first ADC approval for ovarian cancer and is now addressing unmet needs in non-small cell lung cancer (NSCLC) with the approval of a c-Met-targeting ADC.

According to industry sources on December 20, AbbVie obtained domestic approval for its new platinum-resistant ovarian cancer (PROC) ADC, 'Elahere (mirvetuximab soravtansine)', in South Korea on December 19.

The specific indication is for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.

Elahere is an ADC targeting FRα-expressing ovarian cancer, utilizing a mechanism that delivers the potent cytotoxic payload DM4 directly into cancer cells to induce tumor cell death. It is garnering significant attention as a new option for ovarian cancer patients who have developed resistance to platinum-based chemotherapy. As the first new mechanism-of-action drug for platinum-resistant ovarian cancer in approximately 10 years, it was designated as an orphan drug in South Korea this past January.

Elahere is a first-in-class ADC that includes an FRα-binding antibody, a cleavable linker, and maytansinoid payload DM4, a potent microtubule inhibitor, designed to kill targeted cancer cells.

In epithelial ovarian cancer, which accounts for 90% of all ovarian cancer cases, taxanes like paclitaxel and platinum-based agents like carboplatin and cisplatin are primarily used. However, in cases of recurrent ovarian cancer resistant to platinum agents, response rates to the current standard-of-care chemotherapy have been generally low, significantly limiting improvements in survival rates. Elahere proved to be a viable alternative through the Phase 3 MIRASOL study conducted on PROC patients.

In the MIRASOL study, Elahere demonstrated a 35% reduction in the risk of disease progression or death compared to existing non-platinum-based chemotherapy.

The median progression-free survival (PFS) was 5.62 months, an improvement over the 3.98 months in the control group. The objective response rate (ORR) was 42.3%, significantly higher than the 15.9% observed in the standard chemotherapy group.

Median overall survival (OS) was 16.85 months, reducing the risk of death by 32% compared to the 13.34 months in the control group.

Regarding safety, adverse events such as ocular reactions, fatigue, and abdominal pain were reported and generally considered manageable.

Based on these clinical achievements, Elahere received approval in the U.S. in March of last year and in Europe in November of the same year.

The U.S. NCCN guidelines recommend Elahere as a "preferred regimen" (Category 1) for the treatment of FRα-positive PROC patients, and the Korean Society of Gynecologic Oncology also recommends Elahere with the highest level of evidence (Level I, Grade A).

Commercialization of c-Met-targeting 'Emrelis' in NSCLC

New ADC drug 'Emrelis'

AbbVie also succeeded in ovarian cancer by commercializing an ADC for non-small cell lung cancer, following its success in ovarian cancer.

In May, the U.S. Food and Drug Administration (FDA) granted accelerated approval to the c-Met-targeting ADC 'Emrelis (telisotuzumab vedotin)' for adult patients with previously treated locally advanced or metastatic non-squamous NSCLC with c-Met protein overexpression.

c-Met is a protein expressed by the mesenchymal-epithelial transition (MET) gene. As a protein that transmits signals to cells, c-Met is considered a major oncogenic driver and is associated with the development of various solid tumors, including colorectal, gastric, and liver cancers, as well as NSCLC. It is known that c-Met alterations occur in approximately 6% of patients with NSCLC.

Currently, AbbVie’s Emrelis is the only commercialized ADC targeting c-Met alterations.

Emrelis's approval was based on improvements in key endpoints, such as ORR and duration of response (DOR). It is expected to transition to full approval if clinical benefit is confirmed in a confirmatory trial.

Analysis of 84 patients with c-Met overexpression in the Phase 2 LUMINOSITY study showed an ORR of 35% and a median DOR of 7.2 months in the Emrelis arm.

Major adverse events included peripheral neuropathy, fatigue, decreased appetite, and peripheral edema. Grade 3–4 adverse events reported included lymphopenia, increased liver enzymes, and electrolyte imbalances.

Based on this clinical data, Emrelis was also designated as a Breakthrough Therapy by the FDA in 2021.

Currently, Emrelis is under another evaluation as a monotherapy in the Phase 3 confirmatory TeliMET NSCLC-01 study.​