Positive Phase 1b data propels firmonertinib toward pivotal NSCLC trial

Rhea-AI Filing Summary

ArriVent BioPharma (Nasdaq: AVBP) furnished an 8-K to disclose positive interim results from its global Phase 1b FURTHER study evaluating first-line firmonertinib monotherapy in patients with EGFR P-loop and α-C-helix compressing (PACC) mutant non-small cell lung cancer (NSCLC).

At the 240 mg dose, investigators observed a median progression-free survival (mPFS) of 16.0 months and a median duration of response of 14.6 months (cut-off 3 Mar 2025). Tumor shrinkage of ≥30%—the study’s threshold for overall response—occurred in 68.2% of first-line patients at 240 mg versus 43.5% at 160 mg. Among patients presenting with brain metastases, 41% achieved a confirmed response and 53% recorded ≥30% tumor reduction, underscoring central-nervous-system activity.

Safety remained favorable: no Grade 4 or 5 treatment-related adverse events (TRAEs) and no treatment discontinuations; the most common TRAEs were diarrhea, elevated hepatic enzymes, rash, stomatitis and dry skin.

Based on these data, AVBP will launch ALPACCA (FURMO-006), a randomized global Phase 3 trial using the 240 mg dose, with first-patient-in targeted for the second half of 2025. The press release detailing the findings is furnished as Exhibit 99.1; information under Item 7.01 is not deemed “filed” for Exchange Act purposes.

Positive

• Interim Phase 1b data show 16.0-month median PFS and 68.2% tumor shrinkage at the 240 mg dose, indicating strong efficacy signals
• No Grade 4/5 treatment-related adverse events and zero discontinuations, highlighting a favorable safety profile
• Company to commence global Phase 3 ALPACCA trial in 2H 2025, advancing firmonertinib toward potential registration

Negative

• Results are interim Phase 1b findings and must be confirmed in the upcoming Phase 3 study before regulatory submission

Insights

Biotech Equity Analyst

TL;DR: Robust early efficacy & clean safety de-risk Phase 3 launch

The filing presents clinically meaningful signals—a 16-month mPFS and high tumor-shrinkage rates—that compare favorably with historical first-line NSCLC benchmarks. The absence of Grade 4/5 TRAEs and zero discontinuations strengthens firmonertinib’s therapeutic window. Selection of the higher 240 mg dose for pivotal development suggests a clear dose-response relationship. With Phase 3 enrollment slated for 2H 2025, the asset’s path to registrational data is now defined, materially improving program visibility and valuation. Near-term catalysts will revolve around Phase 3 initiation timing and potential regulatory interactions.

Clinical Trial Risk Analyst

TL;DR: Encouraging but still interim; confirmation risk persists

While efficacy and tolerability are promising, the dataset remains early-stage and comes from a limited patient population typical of Phase 1b trials. Reliance on surrogate endpoints such as mPFS and RECIST responses must withstand Phase 3 scrutiny, and the heterogeneous PACC mutation subset could complicate enrollment and outcome interpretation. Nevertheless, clear CNS activity and dose-dependent responses reduce pharmacologic risk, justifying a cautiously optimistic stance ahead of pivotal enrollment.

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UNITED STATES 

SECURITIES AND EXCHANGE COMMISSION 

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT 

Pursuant to Section 13 or 15(d) 

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): June 23, 2025

ARRIVENT BIOPHARMA, INC. 

(Exact name of registrant as specified in its charter)

Delaware		001-41929		86-3336099
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

18 Campus Boulevard, Suite 100 Newtown Square, PA		19073
(Address of principal executive offices)		(zip code)

Registrant’s telephone number, including area code: (628) 277-4836

N/A 

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		AVBP		The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

Emerging Growth Company x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 7.01 Regulation FD Disclosure.

On June 23, 2025, ArriVent BioPharma, Inc. (the “Company”) issued a press release announcing positive interim firmonertinib monotherapy data from its global Phase 1b study in epidermal growth factor receptor (“EGFR”) P-loop and-alpha-c-helix compressing (“PACC”) mutant non-small cell lung cancer (“NSCLC”) and plans to advance into a global pivotal study. 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 June 23, 2025, the Company announced additional follow-up proof-of-concept data from the randomized global Phase 1b FURTHER trial for first-line firmonertinib monotherapy in patients with NSCLC harboring EGFR PACC mutations. In this interim readout, patients treated with 240 mg of firmonertinib were observed to experience 16.0 months median progression free survival (mPFS) and 14.6 months median duration of response by blinded independent central review (BICR) as of March 3, 2025. Majority of the patients treated at 240 mg remained on study after one year as of March 3, 2025. In this interim readout, 68.2% of patients treated in first-line at 240 mg and 43.5% of patients treated in first-line at 160 mg as of March 3, 2025 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 BICR utilizing Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria, which measurement of reduction is the threshold in this trial for determination of the overall response rate (ORR). In addition, 41% (n = 7/17) 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 March 3, 2025 and 53% (n = 9/17) of first line patients with brain metastases at baseline 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 BICR utilizing RECIST 1.1 criteria, which measurement of reduction is the threshold in this trial for determination of the ORR. Firmonertinib was generally well-tolerated with interim safety results as of March 24, 2025 consistent with prior firmonertinib data, and the most frequent treatment-related adverse events (TRAEs) in the study were diarrhea, hepatic enzyme elevation, rash, stomatitis, and dry skin. No Grade 4 or 5 TRAEs were observed, and there were no treatment discontinuations due to TRAEs. Based on the data observed to date, 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 central nervous system antitumor activity consistent with its high brain penetrance.

The Company plans to initiate ALPACCA (FURMO-006), the first randomized global Phase 3 study in first-line NSCLC in patients across PACC mutations, with firmonertinib 240 mg selected as the dose for pivotal Phase 3 development. Enrollment of the first patient in this trial is expected in the second half of 2025.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.		Description
99.1		Press Release dated June 23, 2025.
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: June 23, 2025

FAQ

What progression-free survival did AVBP report for firmonertinib in the Phase 1b FURTHER trial?

The interim analysis showed a median PFS of 16.0 months at the 240 mg dose.

Which firmonertinib dose will be used in the Phase 3 ALPACCA study?

The company selected 240 mg once daily as the pivotal Phase 3 dose.

When will enrollment begin for AVBP’s Phase 3 ALPACCA trial?

First-patient-in is expected in the second half of 2025.

How safe was firmonertinib according to the interim readout?

Firmonertinib was generally well-tolerated with no Grade 4/5 TRAEs or treatment discontinuations.

What CNS activity was observed in patients with brain metastases?

41% (7/17) achieved a confirmed response, and 53% experienced ≥30% tumor reduction in the brain.