Boehringer Ingelheim's new lung cancer drug "Zongaitini" approved in China

On August 29, China's NMPA announced the approval of Boehringer Ingelheim'sInnovative lung cancer drugZongaitini (BI 1810631 ，Zongertinib) Film released in the market，Monotherapy is indicated for the treatment of unresectable locally advanced or metastatic non-small cell lung cancer with HER2 (ERBB2) activating mutations who have received at least one prior systemic therapy.（NSCLC）Adult patient.

Source: NMPA official website

Zongaitini is a drug developed by Boehringer Ingelheim.Selective HER2 inhibitor not targeting EGFR wild type. Preclinical studies have shown that zongaitini is effective against all major HER2 mutations(including HER2 YVMA insertion allele)All exhibit potent inhibitory activity.

Zongaitini can selectively and covalently bind to the receptor tyrosine kinase domain of HER2 exon 20 mutations. This selectivity enables BI1810631 to block only the downstream signaling of abnormal HER2 without affecting wild-type EGFR.(i.e., normal EGFR)Signal pathway, thus canAvoidCommon wild-type EGFR-related effects of other pan-HER inhibitor TKIsDose-limiting toxicity。

April 2024,China BiopharmaceuticalReached a strategic cooperation agreement with Boehringer Ingelheim, under which both parties will leverage their respective strengths and resources to jointly develop and commercialize Boehringer Ingelheim's oncology drug pipeline in mainland China, including Zongaitini.

Source: Insight Database

This approval is primarily based on the results of the Phase Ib clinical study, the BEAMION LUNG-1 trial.. Thisis a study conducted in patients with advanced or metastatic solid tumors with HER2 abnormalitiesAn open-label, Phase Ia/Ib, dose-escalation study of zongaitini as monotherapy(including dose confirmation and expansion)Trial. The primary endpoint of the study was ORR assessed by BICR and investigators.

Phase Ib includes a total of 5 treatment cohorts, with Cohort 1 enrollingHER2 tyrosine kinase domain in treatment（TKD）Mutated NSCLC patients who received daily treatment with 120 mg or 240 mg of zongaitini.After interim analysis, 120 mg was determined as the dose for further evaluation.

In addition, in cohort 3, pretreated HER2-mutant NSCLC patients with either TKD or non-TKD mutations were included. In cohort 5, HER2 TKD-mutant NSCLC patients who had received prior treatment were included.Platinum-based chemotherapy and HER2 ADC treatment.

In December 2024, Boehringer Ingelheim presented Phase Ib clinical data of zenocutuzumab for pretreated patients with HER2-mutant positive advanced NSCLC at the 2024 ESMO Asia Congress.（BEAMION LUNG-1）Queue 1 data.

The results show that zongaitini(dose of 120 mg once daily, n=75 patients)With excellent therapeutic effects,Objective response rate（ORR）was 71%, disease control rate（DCR）Up to 93%Preliminary survival data indicate that zongaitini provides durable responses.6-month progression-free survival（PFS）and duration of relief（DoR）The proportions are 69% and 73%, respectively.。

At the 2025 AACR meeting,Boehringer Ingelheim announced additional key results from the trial, includingQueue 1median DOR and median PFS, as well as preliminary data from cohorts 3 and 5。

As of November 29, 2024, there were 75 patients in cohort 1, 20 non-TKD mutation patients in cohort 3, and 31 patients in cohort 5, all receiving 120 mg zongaitini, with 33 cases in each cohort respectively.（44%）, 4 cases（20%）and 13 cases（42%）The patient is undergoing treatment.

In cohort 1, the ORR assessed by BICR was 71%, and the DCR was 96%.The median DoR and PFS were 14.1 months, respectively.（6.9-NE）and 12.4 months（8.2-NE）。

Moreover,Patients with previously treated brain metastases（n=27）showed intracranial activity, with an ORR of 41% and a DCR of 81%.

In cohort 3, the ORR was 30% and the DCR was 65%.DoR and PFS are not yet mature.

In cohort 5, the ORR was 48% and the DCR was 97%. ，DoR and PFS are respectively5.3 months（2.8-NE）and 6.8 months（5.4-NE）。

In terms of safety, drug-related adverse events were reported in 97%/17%, 80%/25%, and 77%/3% of patients in cohorts 1, 3, and 5, respectively.(All/G≥3), diarrhea is the most common among all queues. There is no drug-related interstitial lung disease（ILD）Case.

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