Zinger Key Points
- Temab-A showed a 63% ORR in advanced EGFR-mutated NSCLC; 54% had responses lasting ≥6 months.
- Pivekimab sunirine achieved 85% ORR and 70% CCR in untreated BPDCN patients, with median CCR duration of 9.8 months.
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AbbVie Inc ABBV stock is trending on Tuesday after the U.S. drug giant announced that key data from its broad oncology portfolio will be showcased at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting.
An oral presentation on investigational elotuzumab 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 from the dose expansion part of a Phase 1 study in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC).
- The objective response rate (ORR) was 63%. High ORR was observed regardless of c-Met protein expression levels.
- At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR).
- Temab-A is also being evaluated in multiple ongoing clinical trials, including:
- Phase 1/2 Study in first-line NSCLC without actionable genomic alterations in combination with budigalimab.
- Phase 2 study in second-line metastatic colorectal cancer (CRC) in combination with fluorouracil, folinic acid, and bevacizumab.
- Phase 3 study as monotherapy in patients with c-Met overexpressing refractory metastatic CRC.
Also Read: FDA Fast-Tracks AbbVie’s New Lung Cancer Therapy Emrelis For Tough Lung Cancer Cases
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 received ABBV-706 monotherapy IV at 1.3–3.5 mg/kg once every 3 weeks.
- The entire cohort had an ORR of 31.3% and a median DoR of 5.6 months.
- This ongoing study is evaluating ABBV-706 as monotherapy or in combination with budigalimab, carboplatin, or cisplatin in patients with advanced solid tumors expressing SEZ6, including small-cell lung cancer, NENs, and high-grade Central Nervous System tumors.
Results from the open-label, multicenter Phase 1b/2 CADENZA trial of PVEK monotherapy in patients with previously untreated or relapsed/refractory (R/R) blastic plasmacytoid dendritic cell neoplasm (BPDCN), a highly aggressive and rare type of blood cancer, demonstrated clinical benefit.
- The results show that among 33 untreated patients, the primary endpoint of composite complete response (CCR) rate, defined as CR + clinical CR (CR with minimal skin abnormality), was 70%, with a median duration of CCR of 9.8 months.
- ORR was 85%.
- In the 51 patients, the CCR rate was 14%, with a median duration of CCR of 9.2 months. ORR was 35%.
- PVEK is also being evaluated in a Phase 1/2 study in R/R and newly diagnosed acute myeloid leukemia.
Price Action: At the last check on Tuesday, ABBV stock was up 1.11% at $185.29 during the premarket session.
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