AbbVie Highlights Solid Tumor Pipeline Progress at ESMO 2024 with New Data on High-Need Tumor Types

AbbVie has announced that new data from its innovative antibody-drug conjugate (ADC) platform will be presented at the European Society for Medical Oncology (ESMO) Congress 2024. The data will focus on three ADCs: mirvetuximab soravtansine (ELAHERE®), telisotuzumab vedotin (Teliso-V), and telisotuzumab adizutecan (ABBV-400). These ADCs are designed to target specific protein biomarkers, such as folate receptor-alpha (FRα) and c-Met (MET protein), which are highly expressed in various tumor types and are often linked to poor prognoses. The ADCs work by delivering potent cancer-killing agents directly to the tumors, using these biomarkers as guides.

The Phase 2 PICCOLO trial evaluated mirvetuximab soravtansine as a monotherapy for FRα-positive, platinum-sensitive ovarian cancer (PSOC). The trial's primary endpoint was met, with an objective response rate (ORR) of 51.9%, including six complete and 35 partial responses among the 79 heavily pre-treated patients. This is significant as more than 80% of the patients had previously been treated with poly (ADP-ribose) polymerase inhibitors (PARPi). Secondary endpoints showed a median duration of response of 8.3 months and a median progression-free survival of 6.9 months. The safety profile was consistent with previous studies, with the most common adverse events being blurred vision, dry eye, nausea, keratopathy, and diarrhea. Additional data will be shared at the ESMO meeting.

Dr. Angeles Alvarez Secord from the Duke Cancer Institute highlighted the urgent need for effective and tolerable therapies for patients with platinum-sensitive ovarian cancer, particularly those pre-treated with PARPi, where response rates to subsequent platinum-based chemotherapies are often diminished. The response rate observed in the PICCOLO trial indicates the potential of mirvetuximab soravtansine for these patients.

Mirvetuximab soravtansine is also being tested in the Phase 3 GLORIOSA trial in combination with bevacizumab for maintenance after second-line platinum-doublet therapy in PSOC. Another Phase 2 trial, IMGN853-0420, is exploring its combination with carboplatin as a second-line treatment for PSOC.

In the Phase 2 LUMINOSITY trial, exploratory patient-reported outcomes (PROs) for Teliso-V in advanced non-small cell lung cancer (NSCLC) will be presented. Teliso-V is being evaluated for its potential as a monotherapy in patients with previously treated c-Met overexpressing, EGFR wild-type non-squamous NSCLC. AbbVie plans to submit Teliso-V for accelerated FDA approval in Q3 2024, with an approval decision expected in 2025.

New data from a Phase 1 study of ABBV-400 will also be presented, showcasing its potential in pre-treated patients with advanced NSCLC and gastroesophageal cancer (GEA). Preliminary results indicate significant antitumor activity, with an ORR of 43.8% in NSCLC patients and 28.6% in GEA patients. The study supports further exploration of ABBV-400 across these and other solid tumors.

Both Teliso-V and ABBV-400 target the c-Met protein but utilize different mechanisms of action. Teliso-V employs a microtubule polymerization inhibitor, while ABBV-400 uses a novel topoisomerase 1 inhibitor.

AbbVie will also present real-world data on the prevalence and prognostic value of c-Met protein overexpression in NSCLC from the METPRO and METEXPRESS studies. These data emphasize the progress of AbbVie's ADC pipeline and its commitment to delivering innovative cancer treatments. 

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