Seven lung cancer companies advancing new treatments in 2025

Lung cancer is the leading cause of cancer-related deaths worldwide, often diagnosed at advanced stages when treatment options are limited. The two most common types of lung cancer are non-small cell carcinoma (NSCLC) and small cell carcinoma (SCLC). While NSCLC is more common and grows slowly, SCLC is less common but is more aggressive and spreads quickly. Although immunotherapy drugs, like Keytruda, and other targeted therapies already exist to treat both NSCLC and SCLC, biotech companies continue to work on developing more effective treatments for lung cancer.

In this article, we take a look at seven lung cancer companies advancing promising candidates.

Candel Therapeutics 

• Technology: Viral immunotherapies 
• Lead lung cancer candidate: CAN-2409
• Recent news: Announced positive survival data for CAN-2409 in NSCLC patients

Cancer vaccine company Candel Therapeutics is working on the development of viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. The company’s lead candidate, CAN-2409, is being investigated for the treatment of lung cancer, pancreatic cancer, and prostate cancer. It was recently shown to have produced positive survival data in patients with advanced NSCLC in a phase 2a trial. 

The candidate is an off-the-shelf adenovirus engineered to deliver the herpes simplex virus thymidine kinase (HSV-tk) gene to a patient’s specific tumor and induce an immune response against the tumor. The HSV-tk enzyme converts orally administered valacyclovir, an antiviral given in combination with CAN-2409, into a toxic nucleotide analogue that kills nearby cancer cells. When given together, this regimen is designed to induce a specific T cell-mediated response against the tumor and distant metastases for broad anti-tumor activity.

In the recent NSCLC trial, the immunotherapy achieved a prolonged median overall survival of 24.5 months in advanced NSCLC patients who had not responded well to treatment with immune checkpoint inhibitors, failed several chemotherapy regimens, and presented with multiple negative prognostic factors at enrollment. Additionally, Candel accepted patients with squamous and non-squamous forms of lung cancer into the study, and a review of long-term survival data on patients who had received CAN-2409 persuaded the company to bet on non-squamous NSCLC as it heads toward a potential registrational trial. 

In December 2024, Candel announced that it had closed a $92 million public offering and said that it intended to use the proceeds from this to continue the development of its product candidates, including preparing submission of a Biologics License Application for CAN-2409 in prostate cancer, and for general corporate purposes.

Cullinan Therapeutics

• Technology: EGFR ex20ins inhibitor
• Lead lung cancer candidate: Zipalertinib
• Recent news: Announced that phase 2b study of zipalertinib met its primary endpoint

Cullinan Therapeutics has a portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. The company’s most advanced candidate, zipalertinib, is an EGFR ex20ins inhibitor being developed for the treatment of NSCLC in collaboration with Japan’s Taiho Pharmaceutical. The small molecule drug recently produced positive topline results in a phase 2b trial in patients with NSCLC harboring EGFR exon 20 insertion mutations who have received prior therapy.

The reason Cullinan is targeting these mutations is that up to 4% of all NSCLC cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype. In fact, in the U.S., approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations. 

The phase 2b study of zipalertinib met its primary endpoint of overall response rate. The company will present the exact results from the study at the upcoming 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. However, Cullinan and Taiho said that the data were generally consistent with previous presentations, likely referring to when Cullinan presented data at the European Society for Medical Oncology Congress from patients with EGFR ex20ins NSCLC who have progressed on or after prior amivantamab treatment. The data from that presentation showed a “consistent objective response rate of approximately 40% and a manageable safety profile.”

Moreover, in April 2024, Cullinan announced that it had raised $280 million in a private placement, the proceeds of which the company said would be used to support Cullinan’s ongoing research and development activities. 

Jazz Pharmaceuticals

• Technology: Alkylating drug
• Lead lung cancer drug: Zepzelca
• Recent news: Announced positive topline results from phase 3 trial of Zepzelca in combination with Tecentriq

With several drugs already approved in different countries for oncology and neuroscience indications, Jazz Pharmaceuticals’ lead lung cancer drug is called Zepzelca (lurbinectedin) and was given accelerated approval by the U.S. Food and Drug Administration (FDA) in June 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy. This approval was based on the overall response rate and duration of response demonstrated in an open-label, monotherapy clinical study.

Two confirmatory trials are now taking place for Zepzelca, which is an alkylating drug that binds guanine residues within DNA, triggering a cascade of events that can affect the activity of DNA-binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death. 

One of the trials is a phase 3 study evaluating the drug in combination with Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) compared to Tecentriq alone as a first-line maintenance treatment. Jazz announced positive topline results for this study in October 2024, showing that the combination therapy outperformed Tecentriq alone, with the addition of Zepzelca delaying disease progression and extending survival. At the time of these results, Jazz said it planned to file for FDA approval for the combination in the first half of 2025. 

Meanwhile, the second, more relevant phase 3 confirmatory trial is evaluating Zepzelca either by itself or in combination with irinotecan (a type of chemotherapy) compared to physicians’ choice of chemotherapy in patients with relapsed SCLC. If positive, the study could confirm the benefit of Zepzelca in the treatment of SCLC and support full FDA approval. It is expected to be completed in April 2026. 

In September 2024, Jazz announced a private offering of $850 million. The company said at the time that it expected to use a portion of the net proceeds to prepay up to approximately $350 million of the term loans outstanding under the credit agreement and use the remainder for general corporate purposes.

MAIA Biotechnology

• Technology: Telomere-targeting small molecule 
• Lead lung cancer candidate: THIO
• Recent news: Raised $1.08 million in a private placement

Focused on targeted therapies for cancer, MAIA Biotechnology is developing its lead candidate, THIO, for the treatment of NSCLC. The small molecule drug works by targeting telomeres, which are regions of repetitive DNA sequences at the ends of chromosomes that protect them from becoming frayed or tangled. Telomeres, along with the enzyme telomerase, also happen to play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO, however, is recognized by telomerase and incorporated into telomeres in cancer cells; once incorporated, the drug compromises the telomere structure and function, leading to “uncapping” of the chromosome ends and resulting in rapid tumor cell death.

THIO is designed to work in tandem with other therapies. For example, according to the company, low doses of THIO followed by anti-PD-L1 or anti-PD1 therapy completely eliminated advanced tumors in preclinical models in vivo, and produced cancer cell-specific immune memory, in which the immune system continued to be active against the cancer cells after extended periods of time with no additional treatment. 

In February 2025, MAIA announced positive efficacy updates from its pivotal phase 2 trial evaluating THIO sequenced with Regeneron’s immune checkpoint inhibitor cemiplimab (Libtayo) in patients with advanced NSCLC who failed two or more standard-of-care therapy regimens. Third-line data showed a median overall survival of 16.9 months for the 22 NSCLC patients who received at least one dose of THIO in parts A and B of the trial. 

Meanwhile, later that same month, the lung cancer company also announced that it had plans to initiate a phase 3 trial in the second half of 2025 to evaluate the efficacy of THIO administered in sequence with a checkpoint inhibitor in third-line NSCLC patients who are resistant to checkpoint inhibitors and chemotherapy.

In December 2024, MAIA raised $950,000 in a private placement, before raising a further $1.08 million in another private placement earlier this month. 

Nuvalent 

• Technologies: ROS1 inhibitor; ALK inhibitor; HER2 tyrosine kinase inhibitor
• Lead candidate: Zidesamtinib
• Recent news: Closed a $575 million upsized public offering

Nuvalent is currently focused on advancing a pipeline of clinical candidates for lung cancer: one for ROS1-positive NSCLC, one for ALK-positive NSCLC, and one for HER2-altered NSCLC. The most advanced candidate is the drug targeting ROS1-positive NSCLC. This therapy, called zidesamtinib (NVL-520), is a brain-penetrant ROS1-selective inhibitor – ROS1 fusions are an oncogenic driver alteration found in up to 3% of patients with NSCLC – created with the aim of addressing tumors driven by ROS1 that have developed resistance to currently available ROS1 inhibitors. 

The candidate is currently being investigated in a phase 1/2 study. Nuvalent initiated the phase 2 portion of the trial in September 2023 and recently said in a press release concerning its anticipated milestones that it expects to report pivotal data for tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive NSCLC from this trial in the first half of 2025. It also said that it plans to submit a new drug application for zidesamtinib by mid-year 2025. 

Meanwhile, the lung cancer company’s second-most advanced clinical candidate, neladalkib (NVL-655), is also being tested in a phase 1/2 trial, with the phase 2 portion initiated in February 2024. The drug is an ALK-selective inhibitor aimed at addressing tumors driven by ALK that have developed resistance to first, second, and third-generation ALK inhibitors. ALK fusions are an oncogenic driver alteration found in up to 5% of patients with NSCLC. Nuvalent expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC from the phase 1/2 trial by the end of 2025. 

In 2021, Nuvalent completed a $135 million series B round. After going public the same year, the company most recently announced that it had closed a $575 million upsized public offering. 

OS Therapies 

• Technology: HER2-targeted immunotherapy
• Lead candidate: OST-HER2
• Recent news: Announced positive results for phase 2b trial of OST-HER2

OS Therapies’ focus is on developing new treatments that activate the immune system to kill cancers that express HER2. The company’s lead asset, called OST-HER2, is a vaccine that makes use of a HER2-bioengineered form of the bacteria Listeria monocytogenes to trigger an immune response against cancer cells expressing HER2. The company had been testing the candidate in a phase 2b trial in patients with recurrent, fully resected, lung metastatic osteosarcoma – a type of bone cancer that spreads to the lungs – for which the company released positive results in January. 

The study achieved its primary endpoint, demonstrating that 33% of patients did not see their cancer return after 12 months. There were also promising results on the secondary endpoint of overall survival during an ongoing three-year follow-up with the patients. Here, the overall survival after one year was 91% for individuals taking OST-HER2 compared to 80% for the historical control group, and after two years, the rates were 61% and 40%, respectively.

OS Therapies’ chief executive officer (CEO) said at the time of the results that the company plans to take the data to the FDA to try to secure an accelerated approval pathway for OST-HER2. 

In December 2024, the immunotherapy company announced that it had closed a $6 million private placement. At the time, the company said that the funding from this is expected to allow it to operate into 2026, by which time it believes it will have delivered the necessary clinical data and other requirements to be granted authorization by the FDA to begin commercialization of OST-HER2 in the U.S.

Summit Therapeutics

• Technology: PD-1xVEGF bispecific antibody
• Lead candidate: Ivonescimab
• Recent news: Ivonescimab met its primary endpoint in another phase 3 trial for NSCLC

Summit Therapeutics is focused on developing a PD-1xVEGF bispecific antibody, called ivonescimab, in partnership with Chinese biotech Akeso, as the two companies entered into a collaboration and license agreement in December 2022, with Summit’s license territories being the U.S., Canada, Europe, Japan, and Latin America. The candidate, which is currently being investigated in global phase 3 trials for the treatment of NSCLC, combines the power of immunotherapy through a blockade of PD-1 with the anti-angiogenesis benefits of an anti-VEGF – two targets critical for tumor growth and survival – into a single molecule. 

In 2024, the drug was given the green light in China in combination with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC. It also gained popularity that year, as data showed that it outperformed Merck’s Keytruda, slashing the risk of disease progression or death by 49% compared with Keytruda in patients with previously untreated, PD-L1-positive NSCLC.

Moreover, in April this year, another phase 3 trial of ivonescimab, this time as part of a chemotherapy combination for first-line treatment of advanced squamous NSCLC, met its primary endpoint of progression-free survival. The combination therapy produced impressive results in both PD-L1-positive and PD-L1-negative patients and showed a favorable safety profile, with no new signals identified. This marked the third successful trial of ivonescimab in lung cancer. 

Summit also announced in February that it had entered into a clinical trial collaboration with Pfizer to test ivonescimab in combination with several of Pfizer’s antibody drug conjugates (ADCs) across multiple solid tumors. 

In September 2024, Summit raised $235 million in a private placement. At the time of the fundraising, the lung cancer company said that it intended to use the proceeds to advance the clinical development of ivonescimab, including in NSCLC and in settings outside of lung cancer. 

Lung cancer treatment market expected to surge in coming years

As numerous companies work to advance their lung cancer therapies through the clinic, we can expect an array of new treatment options to become available in the coming years. In fact, the lung cancer therapeutics market is expected to experience a substantial increase in size, growing from $37.5 billion in 2024 to $112.8 billion by 2034, at a compound annual growth rate (CAGR) of 11.7%. The main drivers of this are an increase in the global prevalence of lung cancer, advancements in cancer therapeutics, and a growing pipeline of innovative treatment options.

This is very positive news for the field, particularly since combination therapies are becoming increasingly popular in the treatment of solid tumors. Ultimately, the more new drugs that reach the market, the more options there will be for patients and their clinicians in selecting a treatment regimen.