The story of vomertinib and Ellis is entering a new stage.

On October 6, Ellis and its overseas partner arrivent jointly released key clinical data. The global phase III fulvent study of single agent first-line treatment of EGFR exon 20 insertion mutation (exon20ins) in advanced non-small cell lung cancer did not meet the primary endpoint of PFS assessed by BICR.

As a phase III clinical trial with a global layout of vometinib, this result quickly triggered a market response.

However, it should be pointed out that the value of a drug can never be denied if a single trial fails to reach the preset endpoint. The R & D of innovative drugs is inherently full of uncertainty. Rather than rushing to identify a failure, what deserves more attention is the long-term ability of enterprises to cope with R & D setbacks.

In fact, in the future study, vometinib still showed efficacy signals in the PFS and other indicators assessed by the investigator, and the safety was also basically consistent with previous studies. For an innovative drug that is still expanding its global indications, how to understand the results and how to promote subsequent clinical development are the real questions to be answered next.

In a larger context, furvent is only a part of the global development of vomertinib. The domestic market continues to grow in large quantities, providing a basis for the commercialization of vometinib. At the same time, other overseas clinical trials of vometinib are still advancing, and Ellis is also gradually building a richer product matrix and extending to new technology fields such as ADC.

Therefore, the data of future still need follow-up analysis, and the long-term development of Ellis cannot be defined by this trial alone.

01. What else does the data reveal besides the primary endpoint?

Let's first look at the most critical data.
 
In the future study, the hazard ratio (HR) of PFS assessed by BICR was 0.75, 95%ci was 0.55-1.02 in the vomertinib 240mg group compared with the chemotherapy group, p=0.0654。
 
From the numerical point of view, the result tends to be vometinib, but the confidence interval crosses 1, and the p value does not reach the preset 0.05 statistical significance standard. Therefore, according to the current data, the study failed to prove that vometinib was significantly superior to chemotherapy in the primary endpoint. Ellis said in the external statement that it was working with arrivent to analyze the complete data of future to determine the follow-up plan.
 
However, further disassembly of the data reveals two noteworthy aspects.
 
First, the vometinib group still showed efficacy signals beyond the primary endpoint.
In the future study, the median PFS assessed by BICR was 11.0 months, the HR was 0.75 (95% ci:0.55-1.02), and the orr confirmed by BICR was 60% in the vormetinib 240mg group. The median PFS assessed by the investigator was 11.1 months, the HR was 0.61 (95% ci:0.46-0.81), and the confirmed orr was 61%.
 
In addition, the baseline situation also provides another perspective. About 40% of patients have brain metastasis, which is the highest level in similar clinical trials. In this case, the median PFS is still up to 11 months, further supporting the efficacy of vometinib.
 
In terms of safety, the safety characteristics observed in the marvel trial were consistent with previous clinical studies of vometinib, and no new safety signals were found. The incidence of grade ≥ 3 adverse events (teaes) in the 240 mg group, 160 mg group and control group were 52%, 53% and 55%, respectively; The incidence of grade ≥ 3 treatment-related adverse events (trae) was 26%, 22% and 40%, respectively.
 
Second, the performance of the control group needs further analysis, which may be an important variable affecting the primary endpoint.
 
In the future, the median PFS of the chemotherapy control group assessed by BICR reached 9.5 months; As a reference, the chemotherapy group in the Papillon study was 6.7 months, and the wu-kong28 study was 7.5 months.
 
It should be emphasized that different clinical studies have differences in the enrollment population, trial design, evaluation methods and other aspects. These figures cannot be directly compared horizontally, nor can they be identified as the reason for the failure to reach the primary endpoint of future based on the higher median PFS of the control group alone.
 
But this result at least shows that the performance of the chemotherapy control group in the future is a variable that cannot be ignored when understanding "not reaching the primary endpoint".
 
The difference between independent review and researcher assessment is more illustrative. The median PFS of the 240mg group was basically the same under the two evaluation methods, which were 11.0 months and 11.1 months, respectively; However, in the chemotherapy group, the BICR assessment was 9.5 months, and the investigator assessment was 7.1 months. In other words, under independent review, the PFS gap between the vometinib group and the chemotherapy group was significantly narrowed, which directly affected the statistical results of the primary endpoint.
 
In addition to this difference, all other data of vometinib performed well: clinical benefit was observed on secondary endpoints such as investigator assessed PFS and confirmed objective response rate assessed by BICR. Although the overall survival (OS) data are not yet mature, a clear trend of improvement has been observed.
 
In fact, it is increasingly common for the control group to perform better than expected. A study published in cancer reviewed 385 phase III randomized controlled trials of cancer. Among 244 evaluable studies, 43% of the trials had the control group performing better than expected; The better the control group performed, the less likely the trial was to reach the primary endpoint. This also shows that the primary endpoint of fulvent has not been reached, and the reason cannot be found only from the side of vometinib. The control group performed better than expected, which is also the key to understand this result.

02. Domestic market, supporting the basic price of veumetinib

It should be made clear that furvent is a global multicenter phase III study involving China, and the approval of vomertinib in China is based on the independent registered clinical trial. Therefore, the results of future will not affect the regulatory status and clinical use of approved indications in China.
 
Vomertinib is the third-generation EGFR-TKI independently developed by Ellis. It was approved for the second-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR mutations in 2021. It was approved for the first-line treatment in June 2022, and both indications have been included in the medical insurance.
 
Among them, the approval of first-line treatment for locally advanced or metastatic NSCLC with EGFR mutations is based on the Furlong phase III study. In the "head to head" comparison with the first generation EGFR-TKI gefitinib, vometinib showed statistically significant and clinically significant superior efficacy in PFS, and also showed advantages in patients with central nervous system (CNS) metastases: in patients with measurable brain metastases, the confirmed CNS orr of vometinib was 91% and that of gefitinib was 65%.
 
The sales volume of vometinib has risen rapidly since its listing in March 2021. The sales revenue from 2021 to 2025 is about 236million yuan, 790million yuan, 1.972 billion yuan, 3.506 billion yuan and 5.120 billion yuan respectively; In the first half of 2026, the revenue of vometinib reached 3.138 billion yuan, and the cumulative sales revenue since its listing has exceeded 14billion yuan.
 
At the same time, the indications of vometinib continue to expand. In February, 2026, the indications for second-line treatment of vometinib EGFR exon20ins mutation were approved for marketing. Thus, vometinib became the only product approved for second-line indications of exon20ins among the three generations of EGFR TKIs.
 
In addition, there are a number of indications related studies of vometinib are being promoted.
 
A new indication for adjuvant therapy after EGFR sensitive mutation surgery has been submitted to the NDA application in September 2026, and is expected to be approved next year; In the direction of adjuvant therapy, Ellis is also promoting the firmost global phase III study - for completely resected stage IB – IIIB non sensitive EGFR mutant NSCLC, 388 Cases are planned to be enrolled, with vormetinib 240mg vs placebo, and the primary endpoint is DFS. The overseas partner arrivent also listed its adjuvant therapy as the direction of cooperation and considered to join; The domestic multicenter phase III registered clinical trial for the first-line treatment of locally advanced or metastatic NSCLC with EGFR PacC / l861q mutation has been enrolled in the first half of 2026 and is currently in the follow-up stage.
 
In addition, there are also many combination drug regimens of vometinib being promoted, opening up more space to provide patients with treatment options.
 
Domestic commercialization has a solid foundation, providing cash flow support for continuous research and development. For Alex, the value of the domestic market lies not only in the current revenue, but also in the stable cash and commercialization base it provides for continuous overseas R & D.
 

03. What are the other cards of vometinib going to sea?

Moreover, the overseas development of vomertinib is not only focused on the EGFR exon20ins mutation. In fact, its global clinical layout also covers other EGFR non common mutations. Among them, the development of uncommon mutations in PacC is the next path worthy of attention.
 
Alpacca is a global phase III study designed to evaluate the efficacy of first-line treatment of EGFR PacC class uncommon mutant advanced non-small cell lung cancer with vormetinib, which is another key clinical registry of vormetinib at this stage.
 
According to the expert consensus on the diagnosis and treatment of advanced NSCLC with EGFR PacC mutation (2025 Edition), PacC accounts for about 12.5% of EGFR mutations. Arrivent estimated that about 42000 NSCLC patients worldwide carry EGFR PacC mutations every year except China. At present, there is no widely used standard treatment for patients with first-line PacC mutations, and the treatment options are very limited.
 
In this context, alpacca, as the earliest and fastest-moving project in the global registration research, deserves attention for its follow-up data. The study plans to enroll about 480 patients, and compare the 240mg of vometinib with the investigator's choice of osimertinib or afatinib. The primary end points include the objective response rate and progression free survival assessed by BICR.
 
The study has completed the first patient administration in December 2025. In January 2026, the relevant indications were included in the list of breakthrough therapeutic varieties by the drug evaluation center (CDE) of the State Drug Administration; On April 30 of the same year, its phase III clinical trial application was approved by the State Food and drug administration.
 
Prior to alpaca, the global phase IB further study had explored the treatment of patients with EGFR uncommon mutations including PacC like mutations with vomertinib.
 
According to the PacC subgroup data published in 2025, there were 22 patients treated with first-line treatment of 240mg of vormetinib. The median PFS after independent review was 16.0 months, and the confirmed objective response rate was 68.2%.
 
These results provide early evidence for the subsequent development of vometinib in PacC mutations. Whether Alpaca can translate the early observed efficacy signals into higher-level clinical evidence remains to be answered by subsequent research results.
 
Furvent is an important clinical layout for the global development of vomertinib, but not all. Alpacca is a more critical follow-up validation project at this stage, and it determines whether vometinib can prove its clinical value in another class of uncommon EGFR mutations.
 
The overseas value of vomertinib should not be defined by a single result of a trial, but should be examined in the global development system of "multi indications, multi research, and multi-stage parallel".
 

04. From a single core product to a multi product matrix, Ellis' multiple growth curves

If vomertinib proves the ability of Ellis' independent research and development and commercialization, the company's product layout in recent years points to another problem: how to move from relying on a single core product to a multi product driven development model?
 
This is first reflected in the construction of product matrix in the field of lung cancer targeted therapy.
 
In addition to vomertinib, golexed targets KRAS G12C mutation, while pratinib covers RET fusion positive related indications. The three products are aimed at different driver genes and patient groups, which makes Alix have a richer product portfolio in the field of lung cancer targeted therapy.
 
With the products such as gorerese and pratinib entering the medical insurance one after another, the company has the opportunity to gradually expand the revenue contribution of non vomertinib products. Products with different targets also provide more possibilities for subsequent combination therapy exploration and patient coverage.
 
However, the increase in the number of products does not necessarily mean that the second growth curve has been formed. What really needs to be tested is whether these products can continue to expand the applicable population, establish clinical competitiveness, and ultimately transform into stable commercial income.
 
Compared with continuing to deepen the layout in the existing fields, another change of Ellis is the extension of small molecule drugs to more technical forms.
 
Ellis is promoting self-developed ADC pipeline. The company previously disclosed that it had established a macromolecular R & D team and took ADC as the priority development direction; Its R & D strategy emphasizes the rationality of target biology, tumor tissue expression, safety window, and the overall design of antibody, linker and load. The company also disclosed that the relevant self-research projects use the linker payload independently developed and have been promoted to the CMC development stage.
 
At the same time, Ellis is also continuously enriching pipelines through BD authorized cooperation.
 
In August 2026, Ellis and arrivent reached a strategic cooperation and obtained the exclusive license of ADC project ast12608/arr-002 in Greater China. This project is a potentially world first muc16/napi2b dual target quadrivalent antibody conjugated drug (ADC). The initial development direction focuses on ovarian cancer and endometrial cancer, and explores the application potential in other solid tumors. The project was approved by the FDA in May 2026 and is currently actively recruiting patients.
 
Through this introduction, the product layout of Ellis has extended from small molecules in lung cancer to macromolecular ADC fields such as gynecological tumors.
 
On the whole, Ellis is forming a three-tier layout: small molecule products for lung cancer with vomertinib as the core are still expanding more indications; Self research has expanded from small molecules to large and small molecules to explore more technical platforms; Through active BD authorization cooperation, the thickness of the pipeline will be broadened and extended to more new technical forms and tumor fields.
 
From single point innovation to platformization, from small molecules to macromolecules, this continuous thickening of "pipeline depth" may be the value of Ellis as an innovative pharmaceutical company that is more worthy of long-term observation.

- Write at the end -

Looking back at this storm, a phase III study did not reach the primary endpoint, which is not uncommon in the research and development of innovative drugs.
 
The first-line study of exon20ins failed to reach the primary endpoint, which will not change the current approved status of the three existing indications of vometinib, nor replace the evaluation of its existing efficacy, safety and evidence of brain metastasis treatment. The clinical performance of vometinib in classic mutations, the approval of exon20ins second-line therapy, and the first release Bureau of PacC registration research together constitute its outstanding clinical and R & D competitiveness.
 
What is really worth paying attention to is whether a company can maintain a clear strategic rhythm after a phased result - overseas clinical practice is still advancing, the domestic basic market is still stable, and the new macromolecular pipeline is in order.
 
For China's innovative pharmaceutical enterprises, the success or failure of a single trial is never the end point. The ability to continuously produce high-quality evidence and steadily expand the global landscape is the watershed that determines the long-term value.

Reference link:
1. ArriVent Announces Program Update from the Phase 3 FURVENT Trial of Firmonertinib in First-Line EGFR Exon 20 Insertion Mutant NSCLC，ArriVent Biopharma
2. Ellis' official announcement, annual report / performance express
3. Control arm overperformance in phase 3 oncology clinical trials，Cancer
4. expert consensus on diagnosis and treatment of EGFR PacC mutant advanced non-small cell lung cancer (2025 Edition), Chinese Journal of Oncology
5. ArriVent Initiates Pivotal Phase 3 ALPACCA Trial for Firmonertinib in EGFR PACC Mutant NSCLC，ArriVent Biopharma
6. Furmonertinib (AST2818) versus gefitinib as first-line therapy for Chinese patients with locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer (FURLONG): a multicentre, double-blind, randomised phase 3 study； The Lancet Respiratory Medicine
7. Central nervous system efficacy of furmonertinib versus gefitinib in patients with non-small cell lung cancer with epidermal growth factor receptor mutations: Results from FURLONG study； Journal of Clinical Oncology