HeartSciences Receives FDA Breakthrough Device Designation for MyoVista

“The data we’re presenting at this year’s ASCO reflect the breadth and depth of our oncology pipeline and our unwavering commitment to research that could transform outcomes for patients facing cancer,” said Roopal Thakkar , M.D., executive vice president, research and development and chief scientific officer, AbbVie. “These presentations underscore our leadership in driving scientific innovation to address some of the most pressing unmet needs in oncology today by leveraging our innovative platforms such as ADCs.”

An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase:

• Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study ( NCT05029882 ). ¹ Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%. ¹ High ORR was observed regardless of c-Met protein expression levels. ¹ At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR). ¹ The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%). ¹ Additional data with 4 months follow-up will be presented at ASCO.

  Temab-A is also being evaluated in multiple ongoing clinical trials including a Phase 1/2 Study ( NCT06772623 ) in first-line NSCLC without actionable genomic alterations in combination with budigalimab (AbbVie’s investigational programmed cell death 1 inhibitor), a Phase 2 study ( NCT06107413 ) in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid and bevacizumab, and a Phase 3 study ( NCT06614192 ) as monotherapy in patients with c-Met overexpressing refractory metastatic CRC.

“The anti-tumor activity of Temab-A in patients with pre-treated, advanced EGFR-mutated non-squamous NSCLC is encouraging and supports further exploration of this novel ADC in this setting,” said Ross Camidge , M.D., Ph.D, University of Colorado Cancer Center, United States and principal investigator of the trial. “Temab-A appears to have a manageable safety profile and continues to show promising clinical activity in advanced NSCLC, which is associated with poor prognosis.”

Additional oral presentations will highlight new safety and efficacy data for ABBV-706, a SEZ6-directed ADC with a Top1i payload, and pivekimab sunirine (PVEK), a novel ADC designed to target CD123:

• In a Phase 1 open-label study of ABBV-706 monotherapy, 64 patients with high-grade neuroendocrine neoplasms (NENs), a diverse group of rare and aggressive solid tumors, received ABBV-706 monotherapy IV at 1.3–3.5…