Taiho Oncology Inc. and Cullinan Therapeutics (CGEM:NASDAQ) have announced new data from the central nervous system (CNS) cohort of the REZILIENT2 Phase 2b clinical study evaluating zipalertinib, an oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, in patients with advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations and CNS involvement. The results were presented during the European Society for Medical Oncology (ESMO) Congress 2025 as part of the "NSCLC metastatic" session.
The presentation featured preliminary efficacy and safety results from patients enrolled in the CNS involvement cohort of the ongoing REZILIENT2 study. As of February 2025, 32 patients had received zipalertinib 100 mg orally twice daily. Of these, 21 patients had EGFR exon 20 insertion mutations and 13 carried other uncommon mutations. Among patients with measurable CNS disease, the intracranial objective response rate (ORR) was 31.3%, with one complete intracranial response. The intracranial disease control rate (iDCR) reached 68.8%, and the median intracranial duration of response was 8.1 months. Systemically, the study reported a preliminary ORR of 27.6% and a median duration of response of 7.6 months. No new safety concerns were observed, with the treatment generally well tolerated at the administered dose.
"Treatment options are limited for patients with NSCLC with EGFR mutations and active brain metastases," said Dr. Helena A. Yu, Thoracic Medical Oncologist at Memorial Sloan Kettering Cancer Center, in the news release. "We are pleased to see that in approximately one-third of patients exposed to zipalertinib, a decrease in CNS lesions was observed."
The REZILIENT2 trial continues to evaluate zipalertinib across multiple cohorts, assessing safety, efficacy, and pharmacokinetics in NSCLC patients with both EGFR exon 20 insertion and uncommon mutations. The drug, co-developed by Taiho Oncology and Cullinan Therapeutics, has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA).
Behind The Biotechnology and Oncology Therapeutics Sector
According to a 2025 annual report from Vision Research Reports, the global oncology market was valued at approximately US$321.19 billion in 2024 and was calculated at US$356.20 billion in 2025. The report noted that the market had been projected to reach around US$903.81 billion by 2034, growing at a compound annual growth rate (CAGR) of 10.9% over the forecast period. Growth had been attributed to an increasing global cancer burden, the expansion of healthcare infrastructure, and the advancement of early detection technologies. Vision Research Reports wrote that "the lung cancer segment registered the maximum market share of 37% in 2024," citing the disease's status as the most common and deadly cancer worldwide.
The same study reported that new treatment modalities such as immunotherapy, monoclonal antibodies, and cell and gene therapies had continued to shape the market. It stated that "the development and growing adoption of immunotherapies such as tumor-infecting viruses, checkpoint inhibitors, cytokines, monoclonal antibodies, and the development of cancer vaccines" had been contributing factors to improved remission and survival rates. The report also emphasized the impact of precision medicine and artificial intelligence (AI) in diagnostic imaging and treatment planning, noting that these technologies had improved accuracy and efficiency in cancer care.
In June, BCC Research issued its own analysis titled Global Cancer Therapeutics Market: Emphasis on Recurrent and Metastatic Divisions, which forecasted growth to US$168.0 billion by 2029. The report found that metastatic disease remained responsible for approximately 90% of cancer-related deaths, underscoring the ongoing need for innovation in recurrent and metastatic cancer treatment. BCC Research wrote that "the aggressive nature of metastatic disease and the challenge of overcoming resistance to existing therapies highlight the importance of this market." It also stated that the sector's expansion had been driven by "approval of oncology drugs, technological advances, and increasing cancer incidence," supported by the accelerated approval processes of regulatory bodies such as the U.S. Food and Drug Administration.
According to the same BCC Research publication, North America represented the largest market region, valued at US$48.1 billion in 2023 and projected to reach US$75.3 billion by 2029. Lung cancer was identified as the dominant cancer type through the forecast period, while innovations such as combination therapies integrating immunotherapy, targeted therapy, and chemotherapy were cited as major drivers of efficacy improvements.
In September, Precedence Research published a report which explained that "the oncology CDMO market is expanding rapidly as rising cancer prevalence fuels demand for specialized outsourcing in drug development and manufacturing." It highlighted antibody-drug conjugates (ADCs), cell and gene therapies, and AI-enabled efficiencies as key trends. The analysis stated that the increasing complexity of cancer drug development had made outsourcing "both a strategic and economic necessity," particularly as pharmaceutical companies sought scalable manufacturing solutions and regulatory expertise.
The CDMO report also found that North America had maintained a dominant position in 2024 due to its advanced healthcare infrastructure and concentration of oncology innovation, while the Asia-Pacific region had emerged as the fastest-growing area driven by cost-efficient manufacturing and expanding clinical research capacity. It further noted that "monoclonal antibodies accounted for a considerable share of the market in 2024," reflecting their widespread use in treating solid tumors and hematologic malignancies.
Analysts Reaffirm Confidence in Cullinan Therapeutics
On September 12, H.C. Wainwright & Co. reiterated its Buy rating on Cullinan Therapeutics Inc. with a 12-month price target of US$24. Analysts Robert Burns and Raghuram Selvaraju noted that updated data from the pivotal Phase 2b REZILIENT1 trial of zipalertinib, presented at the World Conference on Lung Cancer (WCLC), demonstrated continued clinical benefit in patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. According to the report, zipalertinib achieved a 35% overall response rate (ORR), a median duration of response (DOR) of 8.8 months, and a median progression-free survival (mPFS) of 9.4 months in the broader study population. The analysts highlighted that "zipalertinib demonstrated a 31.5% ORR in patients previously treated with amivantamab and no other ex20ins-targeted therapy, and a 20% ORR in those treated with both amivantamab and another ex20ins-targeted therapy."
The report described zipalertinib as remaining "in focus," with pending regulatory discussions with the U.S. Food and Drug Administration expected to determine the next stage of advancement. H.C. Wainwright stated that Cullinan had been eligible to receive an additional US$130 million in regulatory milestones under its collaboration agreement. The analysts used a discounted cash flow (DCF) valuation methodology with a 70% probability of launch for zipalertinib in exon 20-positive NSCLC and maintained confidence in the company's balance sheet strength, citing US$510.9 million in cash and no debt as of mid-2025.
On October 13, 2025, Wedbush Securities reaffirmed its Outperform rating on Cullinan Therapeutics with a US$23 price target following the presentation of data from the REZILIENT2 CNS cohort at the European Society for Medical Oncology (ESMO) Congress 2025. Analysts Robert Driscoll, Ritika Das, and Geoffrey Von Der Ahe wrote that "these data bolster zipalertinib's profile as a novel EGFR inhibitor with broad application in treating exon 20 insertion NSCLC, including those with difficult-to-treat brain metastases." The firm noted that the updated findings supported the therapy's intracranial efficacy, with an objective response rate of 31.3% and a disease control rate of 68.8%, including one complete intracranial response.
Wedbush observed that the results aligned with earlier findings from the REZILIENT2 study presented at ASCO 2025, confirming consistent systemic and intracranial activity. The analysts emphasized that safety remained manageable, with adverse events "consistent with previous studies." The firm valued Cullinan by applying a 6–8x multiple to estimated U.S. sales and European royalties from its clinical assets, including zipalertinib, discounted by 20–30% annually.
Expanding Precision Oncology Capabilities
Cullinan Therapeutics described zipalertinib as a next-generation, irreversible EGFR inhibitor designed to selectively target activating mutations while sparing wild-type EGFR. In its September 2025 corporate presentation, the company highlighted the molecule's best-in-class potential for EGFR exon 20 insertion NSCLC and noted that pivotal Phase 2b REZILIENT1 trial results met the primary endpoint earlier this year.
Cullinan reported a cash position of approximately US$511 million as of June 30, 2025, supporting operations into 2028. The company also stated that discussions with the FDA regarding a potential New Drug Application for zipalertinib in relapsed EGFR exon 20 insertion NSCLC were expected by year-end, led by Taiho Oncology.
Beyond zipalertinib, Cullinan continues to advance a diversified pipeline that includes multiple T cell engager (TCE) programs for oncology and autoimmune diseases. The company's research model emphasizes highly differentiated molecules designed to create new standards of care for targeted patient populations.
Through its collaboration with Taiho Oncology, Cullinan has positioned zipalertinib as a leading candidate for genetically defined subsets of lung cancer. The results presented at ESMO 2025 further support ongoing development efforts and underscore the companies' shared goal of advancing targeted therapies for patients with significant unmet needs.
Ownership and Share Structure
Refinitiv reports that 3.33% of Cullinan Therapeutics is owned by strategic entities and 1.58% is held by management and insiders. Institutions hold 114.88%.
The company has a market capitalization of US$462.55 million, 54.76 million free float shares, and a 52-week trading range of US$5.68-US$17.94
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