ArriVent BioPharma, Inc. reports news as a clinical-stage biopharmaceutical company developing oncology therapeutics. Company updates center on firmonertinib, an EGFR inhibitor for EGFR mutant non-small cell lung cancer, including exon 20 insertion and PACC mutation settings, as well as regulatory designations, clinical data presentations, and global study activity.
Recurring developments also cover ArriVent's antibody-drug conjugate portfolio, including ARR-217, a CDH17-targeted ADC for gastrointestinal malignancies, and ARR-002, a MUC16/NaPi2b targeting tetravalent ADC with an initial focus in ovarian and endometrial cancers. News releases also include IND clearances, oncology conference presentations, financial results, collaborations, and executive or commercial organization updates.
ArriVent BioPharma (Nasdaq: AVBP) reported initial Phase 1 results for ARR-217 in heavily pretreated gastrointestinal cancer patients at ESMO Congress 2026. ARR-217 is a CDH17-targeting antibody-drug conjugate developed with Lepu Biopharma. At the August 5, 2026 cutoff, 123 patients had received treatment, including 113 with colorectal cancer (CRC).
At 6 mg/kg every three weeks, the objective response rate was 44.8% (13/29) in CRC: seven confirmed partial responses, four pending confirmation and two unconfirmed. Disease control was 93.1%. At 4 mg/kg and higher, CRC response and disease control rates were 34.2% and 91.8%, respectively. Across all doses, Grade 3 or higher treatment-related adverse events occurred in 30.1%; no Grade 5 treatment-related events or interstitial lung disease were observed. ARR-217 has advanced into Phase 1b dose optimization at 5 and 6 mg/kg every three weeks; ArriVent expects further data in 2027.
ArriVent BioPharma (Nasdaq: AVBP) will present initial Phase 1 safety and efficacy data for ARR-217 at ESMO on October 25, 2026.
The first-in-human study (NCT07066657) evaluates the CDH17-targeted antibody-drug conjugate in patients with gastrointestinal cancers. Abstract LBA34 is scheduled for the Rapid Oral Session from 8:30–10:00 AM CEST in Madrid. ArriVent plans to host a virtual webinar on October 26, 2026, at 8 AM ET to discuss the data and the ARR-217 program.
ArriVent BioPharma (AVBP) announced publication in Cancer Cell of Phase 1b results evaluating firmonertinib in previously untreated EGFR PACC-mutant lung cancer. In advanced non-small cell lung cancer, confirmed overall response rates were 43% at 160 mg and 68% at 240 mg; median progression-free survival, the time without disease worsening, was 11.1 and 16.0 months, respectively. Both measures underwent blinded independent central review.
Among 17 patients with baseline brain metastases, confirmed intracranial response was 47%, including 41% complete responses. Treatment-related adverse event rates were consistent with prior firmonertinib studies. Enrollment continues in the global Phase 3 ALPACCA trial, comparing firmonertinib with investigator-selected osimertinib or afatinib.
ArriVent BioPharma (Nasdaq: AVBP) dosed the first patient in its U.S. Phase 1 trial of ARR-002 for ovarian and endometrial cancer. ARR-002 is an antibody-drug conjugate (ADC), an antibody linked to a drug, targeting MUC16 and NaPi2b. It is the company's second ADC to enter clinical testing.
ArriVent said the program broadens its clinical pipeline beyond lung and gastrointestinal cancers. In August 2026, it entered an exclusive agreement with Shanghai Allist Pharmaceuticals to develop and commercialize ARR-002 in Greater China, retaining all rights outside that territory.
ArriVent BioPharma (AVBP) announced that its Phase 3 FURVENT trial of firmonertinib in previously untreated lung cancer missed its primary endpoint.
The trial enrolled patients with locally advanced or metastatic non-squamous non-small cell lung cancer carrying EGFR exon 20 insertion mutations. Median progression-free survival, time without cancer worsening, by blinded independent central review was 11.0 months at 240mg and 8.4 months at 160mg, versus 9.5 months with control; the 240mg comparison had a p-value of 0.0654. Confirmed response rates by independent review were 60%, 35% and 33%, respectively. Investigator-assessed median progression-free survival was 11.1, 8.3 and 7.1 months, respectively.
ArriVent reported an improvement trend in overall survival, but those data are not yet mature. No new safety signals were identified. The company is evaluating the full dataset to determine firmonertinib's development path.
ArriVent BioPharma (Nasdaq: AVBP) reported second quarter 2026 results and clinical progress. Topline global pivotal Phase 3 data for firmonertinib in first-line EGFR exon 20 insertion mutant NSCLC are anticipated in 2H 2026, while the ALPACCA Phase 3 trial in EGFR PACC mutant NSCLC continues globally.
ArriVent advanced ARR-217, a CDH17‑targeted ADC for gastrointestinal cancers, into Phase 1b dose optimization and is preparing first patient dosing of ARR-002, a dual MUC16/NaPi2b tetravalent ADC, in Q3 2026. Cash and investments were $373.1 million at June 30, 2026, expected to fund operations into 2028. For the six months ended June 30, 2026, research and development expenses were $80.0 million, general and administrative expenses $18.8 million, and net loss $93.2 million.
ArriVent BioPharma (Nasdaq: AVBP) reported first quarter 2026 results and pipeline progress. Cash and investments were $326.4 million as of March 31, 2026, expected to fund operations into 4Q 2027. Net loss was $43.3 million, with R&D expenses of $37.6 million and G&A of $8.5 million.
ArriVent highlighted pivotal Phase 3 firmonertinib programs in EGFR-mutant NSCLC, including expected topline FURVENT data in mid-2026 and China NMPA accelerated approval in second-line EGFR exon 20 insertion NSCLC. ARR-217 and dual-target ADC ARR-002 advanced via FDA IND clearances, with first patient dosing for ARR-002 targeted for 2H 2026.
ArriVent (Nasdaq: AVBP) announced FDA IND clearance for ARR-002, a tetravalent MUC16/NaPi2b-targeting antibody-drug conjugate with initial focus in ovarian and endometrial cancers. The company reported preclinical data showing enhanced dual-target binding, improved internalization, superior in vivo efficacy in OVCAR-3 xenografts, and a favorable tolerability profile in cynomolgus monkeys. ArriVent expects to begin a Phase 1 trial and dose the first patient in the second half of 2026.
ArriVent (Nasdaq: AVBP) will present two preclinical posters at the AACR Annual Meeting April 17-22, 2026 in San Diego.
Highlights include structural and preclinical data for the EGFR inhibitor firmonertinib supporting broad activity including exon 20 insertion mutants and high brain penetrance, and preclinical results for dual-target tetravalent ADC ARR-002 (AV-P138-ADC) showing superior efficacy and favorable tolerability in ovarian and endometrial cancer models.
Aarvik Therapeutics (NASDAQ: AVBP) will present two posters and a minisymposium talk at AACR Annual Meeting 2026 in San Diego (April 17–22, 2026). Presentations include data on AV-P138-ADC (ARR-002), the MUTTA™ multispecific ADC platform, and AQUALINK™ exatecan linker-payload innovations.
Poster and minisymposium dates/times: Poster 2660 on April 20 (9 AM–12 PM PT); Minisymposium 6758 on April 21 (2:30–4:30 PM PT); Poster 5757 on April 21 (2–5 PM PT).