공시 • Jan 05
Aveo Oncology Highlights Recent Progress and 2022 Outlook
AVEO Oncology highlighted its recent progress and outlook for 2022. The team executed the U.S. commercial build out by hiring and training field teams and building infrastructure – including distribution, patient access and securing broad reimbursement. Market penetration for FOTIVDA has continued to increase since its commercial launch at the end of March 2021. Feedback from the field team suggests FOTIVDA has been well received by oncologists treating r/r RCC, noting both the durable responses and tolerability profile they have observed as attractive for their third-line patients. As with other launches during the COVID-19 pandemic, the sales team’s access to oncologists and their staff has been limited which the Company believes has potentially slowed the launch trajectory. This headwind continued in the fourth quarter of 2021 with the emergence of the Delta and Omicron COVID-19 variants. Despite these access challenges, AVEO expects to have continued quarter over quarter net revenue and underlying prescription demand growth in the fourth quarter of 2021. In addition, as is typical with launches in the relapsed/refractory oncology setting, physicians will tend to prescribe newly approved therapies for later line patients and, following positive experience with a new therapy, will prescribe to earlier line patients. To date, the majority of the patients prescribed FOTIVDA have been 4th line or later. Expect later line patients to generally exhibit higher early discontinuation rates. With slower account access due to COVID-19 related restrictions, the Company believes that broad product adoption in earlier lines of treatment may continue to be protracted. AVEO continues to believe FOTIVDA has the potential to become a standard of care for patients that have received two or more prior systemic treatments. These data included updated durability of response (DOR) and overall survival (OS) results, as well as an analysis of treatment-emergent adverse events (TEAEs) across trial arms. Tivozanib demonstrated clinically meaningful and statistically significant improvements in overall response rate (ORR) and DOR compared to sorafenib in highly relapsed or refractory RCC patients in the TIVO-3 trial. In addition, the long-term OS relative to sorafenib continued to improve with a hazard ratio of 0.91, as presented at ASCO 2021. Patients in the TIVO-3 trial demonstrated a longer duration of treatment exposure with tivozanib than sorafenib (11.9 cycles vs. 6.7 cycles), but fewer all-grade and grade =3 TEAEs. The observed TEAEs were generally similar with tivozanib and sorafenib. Patients receiving tivozanib in the TIVO-3 trial required fewer dose reductions, and the time to dose reductions were longer with tivozanib than sorafenib. Data highlighting outcomes of the subgroup of TIVO-3 patients who received tivozanib following prior axitinib therapy suggests that tivozanib, a potent and selective vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI), is more active following prior VEGFR TKI therapy than sorafenib, a multi-targeted VEGFR TKI. Tivozanib demonstrated significantly increased quality-adjusted time without symptoms of disease and toxicity (QTWiST) relative to sorafenib as third- or fourth-line therapy in patients with RCC. A Phase 3 clinical trial of tivozanib in combination with Bristol-Myers Squibb’s OPDIVO® (nivolumab), an antibody directed against programmed death-1 (PD-1), versus tivozanib monotherapy for the treatment of RCC patients progressing after one or two ines of prior therapy, one of which must include immunotherapy, opened for enrollment during the third quarter of 2021. This is a study of tivozanib in combination with IMFINZI® (durvalumab), AstraZeneca’s human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in patients with unresectable locally advanced or metastatic HCC. The trial has completed enrollment of the first-line cohort and is currently enrolling a second cohort of patients after pre-treatment with bevacizumab and atezolizumab in a prior line of therapy. The Company expects to present the data from the first-line cohort at ASCO GI in January 2022. Data from the portion of the trial that included patients with HPV negative disease, a subgroup of metastatic HNSCC normally associated with poorer outcomes, who received the combination of ficlatuzumab and cetuximab demonstrated improved responses, including two patients with complete responses, which compares favorably to historical controls. BAVEO has begun the manufacturing scale up and expects to commence manufacturing of ficlatuzumab clinical supply in the second quarter of 2022. In support of the proposed HPV negative HNSCC Phase 3 clinical trial of ERBITUX® (cetuximab) and ficlatuzumab, AVEO recently entered into a clinical trial collaboration and supply agreement for ERBITUX for the EU study sites with Merck KGaA, Darmstadt, Germany. AVEO expects to continue to discuss potential ficlatuzumab registrational clinical trial designs with the FDA and with potential partners. AV-380 is a first-in-class, potent, humanized inhibitory IgG1 monoclonal antibody targeting growth differentiation factor 15 (GDF15), a potential treatment pathway for cancer and/or cachexia. The last patient has been dosed in the Phase 1 clinical trial of AV-380 in healthy volunteers. AVEO expects to present data from the Phase 1 clinical trial in mid-2022 at a scientific meeting. AVEO plans to initiate a Phase 1b clinical trial in cancer patients in mid-2022. During 2021, AVEO regained worldwide rights to AV-203. AV-203 is a clinical-stage potent humanized IgG1 monoclonal antibody that targets ErbB3 (also known as HER3). AV-203 has demonstrated preclinical activity in a number of different tumor models, including breast, head and neck, lung, ovarian and pancreatic cancers. FOTIVDA® (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.