UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01 | Regulation FD Disclosure. |
September 9, 2024, ArriVent BioPharma, Inc. (the “Company”) issued a press release announcing positive proof-of-concept global Phase 1b interim data for firmonertinib monotherapy in first-line EGFR PACC mutant non-small cell lung cancer at the 2024 World Conference on Lung Cancer. A copy of the press release is furnished as Exhibit 99.1 hereto.
The information set forth in this Item 7.01 and Exhibit 99.1 shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 8.01 | Other Events. |
On September 9, 2024, the Company announced positive interim proof of concept data for firmonertinib monotherapy from a global study of firmonertinib in first-line epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC) patients with P-loop and-alpha-c-helix compressing (PACC) mutations, which the Company believes represents the first clinical dataset of an EGFR inhibitor being tested in a randomized defined population of EGFR PACC mutant NSCLC. In this interim readout, 81.8% of patients treated in first-line at 240mg and 47.8% of patients treated in first-line at 160mg as of June 20, 2024 were observed to experience a reduction in tumor size of at least 30% from the baseline in a patient without evidence of progression as measured by blinded independent central review (BICR) utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, which measurement of reduction is the threshold in this trial for a partial response and for inclusion in determination of the overall response rate (ORR). In this interim readout, 63.6% of patients treated in first-line at 240mg and 34.8% of patients treated in first-line at 160mg were observed to experience a confirmed response as measured by BICR utilizing RECIST 1.1 criteria as of June 20, 2024. Median duration of response had not yet been reached, with 90.9% (n = 20/22) of patients with confirmed responses remaining on study. In addition, 46.2% (n = 6/13) of first line patients with brain metastases at baseline were observed to experience a confirmed response utilizing modified RECIST 1.1 by BICR as of June 20, 2024. Firmonertinib was generally well-tolerated with interim safety results as of July 5, 2024 consistent with prior firmonertinib data, and the most frequent treatment-related adverse events (TRAEs) in the study were diarrhea, rash, dry skin, stomatitis, and hepatic enzyme elevation. No Grade 4 or 5 TRAEs were observed, and there were no treatment discontinuations due to TRAEs. The Company believes firmonertinib showed promising dose-dependent activity in NSCLC patients across a broad range of EGFR PACC mutations in the first-line metastatic setting and includes central nervous system antitumor activity consistent with its high brain penetrance.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Press Release dated September 9, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
| ARRIVENT BIOPHARMA, INC. | ||
| By: | /s/ Winston Kung, MBA | |
| Winston Kung, MBA | ||
| Chief Financial Officer and Treasurer | ||
Date: September 9, 2024