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We’re nearly halfway through 2025, and like clockwork, the American Society of Clinical Oncology (ASCO) annual summit took place from the 30th of May to the 3rd of June in Chicago this year. With biotechs from across the U.S. as well as from different parts of the world attending, the five-day event was packed with presentations from researchers and drug developers in the cancer therapeutics space. Here are some of the highlights from the event, according to attendees at ASCO 2025.
More than half the sessions at ASCO 2025 touched on immunotherapies, cell and gene therapies, and antibody-drug conjugates (ADCs) whereas about 10% of the content was focused on traditional modalities of chemotherapy, radiation, and surgery, according to Musaddiq Khan, vice president of Digital and TA Strategy at California-based Medable.
Table of contents
Immunotherapies in high demand; fueling R&D
The immunotherapy market size was valued at $226.38 billion last year, and it is only projected to grow by almost 12% by 2030, according to Grand View Research. So, with research and development (R&D) expanding in the field, it would come as no surprise that immunotherapies were a hot topic at ASCO 2025.
“Over the past five to 10 years, clinical investigation into the application of immunotherapy in solid tumors has essentially exploded,” said Emil Lou, Professor of Medicine, Division of Hematology, Oncology, and Transplantation at the University of Minnesota.
A prime example of this is Imfinzi’s impact on solid tumors, which was showcased at ASCO 2025. The AstraZeneca-owned therapy has been on the market for eight years now to treat a host of cancers. According to the latest data presented at ASCO, it could be pivotal in addressing early-stage stomach cancer.
When given along with chemotherapy before and after surgery to patients with early-stage stomach cancer, the monoclonal antibody lowered the risk of the cancer returning or progressing by 29%. A 67.4% event-free survival (EFS) rate – which measures the effectiveness of cancer treatments – was observed when Imfinzi was given in combination with chemotherapy compared to 58.5% in the placebo-chemotherapy cohort after 24 months.
This trial defines a new paradigm for patients with early-stage and locally advanced gastric and gastroesophageal junction cancers and shows the benefits of giving our best treatments earlier,” said Pamela Kunz, director of the Center for Gastrointestinal Cancers at Smilow Cancer Hospital and Yale Cancer Center, in a statement published in ASCO.
Another immunotherapy in the 2025 ASCO limelight was Keytruda. Pharma giant Merck’s PD-1 inhibitor antibody was first greenlit by the U.S. Food and Drug Administration (FDA) more than a decade ago to treat advanced melanoma, a type of skin cancer. Keytruda has racked up FDA approvals since then, and now, encouraging data suggests that it could offer more than just first-line treatment for patients with head and neck cancer – a type of cancer that has seen very few therapeutic advances in recent times.
Keytruda, which works by blocking the PD-1 pathway – a pathway that helps cancer cells avoid being attacked by the immune system – was found to not only double the average time it takes for a cancer to return to five years but also cut the risk of cancer from spreading when used alongside surgery in a trial evaluating 714 patients.
Prof Kevin Harrington, who led the trial in the U.K., said that the immunotherapy could “change the world” for patients with head and neck cancers, in a BBC article.
PDS Biotech’s Versamune HPV addresses HPV-positive cancers
Of late, there has been a rise in cases of head and neck cancer – an NBC report called it a “silent epidemic” spreading among men. Almost half the cases of head and neck squamous cell carcinoma (HNSCC) in the U.S. are human papillomavirus (HPV)16-positive. This strain has been identified as “the most carcinogenic type of HPV,” and patients are more likely to experience disease progression, according to Frank Bedu-Addo, chief executive officer (CEO) of New Jersey-based PDS Biotech, a company developing an immunotherapy for head and neck cancer.
“Epidemiologists have identified HPV16 as the primary reason for the increasing incidence of HNSCC, and immunological scientists have also identified the mechanisms by which HPV16 shuts down the immune system’s ability to respond to the infection, thereby promoting the growth of tumors with low immunogenicity that are more difficult to treat,” said Bedu-Addo.
PDS’ Versamune HPV is designed to help immune cells to recognize HPV-related cancer cells and attack them. The phase 2 candidate was tested in combination with Keytruda in a study consisting of people with HPV-positive head and neck cancer. Patients who enrolled in the study had a 50% chance of surviving for 30 months, according to Jared Weiss, section chief of Thoracic and Head/Neck Oncology and principal investigator of the study, who presented the data at ASCO 2025. Now, a phase 3 trial of the combination therapy is ongoing. The candidate is also in the clinic for cervical cancer.
Another clinical-stage biotech that unveiled data from its cancer immunotherapy trial is Paris-based Enterome. Its candidate EO4010 is made up of five microbial-derived peptides that mimic CD8+ T cell epitopes to fight cancer cells, specifically colorectal cancer.
In a phase 1/2 trial, a 40% survival rate was observed in patients treated with EO4010 in combination with the monoclonal antibody Opdivo at 12 months at a median follow-up of 15.4 months. Currently, there is a plateau at 34% survival, with seven of 20 patients still alive, explained Pierre Belichard, CEO of Enterome.
“Colorectal cancer continues to be a major therapeutic challenge, with many patients dying prematurely,” said Belichard. “The data are another confirmation of the strong potential of our OncoMimics immunotherapy for cancer, in this case for microsatellite stable (MSS)/mismatch repair proficient (pMMR) metastatic colorectal cancer (mCRC). Treatment options are limited for these types of cancers, and so far, EO4010 has already delivered promising survival outcomes and objective responses, including in liver metastases, without complex side effects.”
Where do checkpoint inhibitors stand?
Meanwhile, the efficacy of checkpoint inhibitors like nivolumab, popularly known as Opdivo, received airtime at ASCO 2025.
“Deploying checkpoint inhibitors as (neo)adjuvant therapies across multiple cancer types has provided promising outcomes in several clinical trials, as highlighted at ASCO,” said Kuan-Chuan (Eric) Pao, senior scientist and founder of Outrun Therapeutics.
The checkpoint inhibitor Opdivo reduced the risk of disease recurrence or death by 24% in patients who had undergone head-and-neck cancer surgery when given along with standard chemotherapy in a phase 3 trial, Pao pointed out.
However, Lou thinks that immunotherapies like checkpoint inhibitor drugs are still lagging behind in making a difference in the field.
“A central role and current key trend for oncology research is to decipher ways to modulate the tumor microenvironment in ways that could ‘prime’ tumors to make them more susceptible to immunotherapies. Tumor-agnostic use of checkpoint immune inhibitors has been remarkable for patients with tumors harboring deficient mismatch repair proteins (dMMR), resulting in microsatellite instability (MSI),” said Lou. “However, a relatively small number of patients have such hallmarks present or identified on routine testing.”
Biomarkers to identify suitable immunotherapies for patients
So, the use of various biomarkers to detect cancers like gastric cancers can make it easier to choose the correct treatment for patients, he added. Like, for instance, in colorectal cancers, biomarkers have shifted from prognostic biomarkers to ones that are “predictive of potential efficacy when using targeted therapies.”
“I am seeing more cases of young adult and early-onset colorectal and other gastrointestinal (GI) cancers in my practice. Moreover, the vast majority of patients who present to me for initial or second opinions have stage IV or metastatic forms of these cancers that are not considered curable using current standards of care. To effectively target GI cancers, we have to identify these targets first – so I am very proactive about requesting comprehensive genomic profiling as soon as possible, whether by testing the tumor specimen from biopsy or by requesting liquid-based biopsy,” said Lou, who has previously served on the ASCO Scientific Committee for GI Cancers.
Cancer therapeutics witnessing a “paradigm shift”
As immunotherapies have been a major talking point at ASCO 2025, it is reflective of the current state of cancer care today.
“The field of cancer therapeutics is witnessing a paradigm shift, with immunotherapy combinations increasingly redefining treatment standards, and not only in late-stage disease, but now also in earlier treatment settings,” said Stephan Schann, chief scientific officer (CSO) of French company Domain Therapeutics.
In tumors, where progress had stalled for nearly 20 years, an international phase 3 study led by French physicians from Gortec, a group dedicated to head and neck oncology, demonstrated the benefit of combining immunotherapy with the standard-of-care radiotherapy and chemotherapy, explained Schann.
“Patients receiving this triplet therapy experienced a significant improvement in overall survival and disease-free survival. This is a major achievement in a tumor type with a historically high risk of relapse,” said Schann.
Echoing Schann’s thoughts, Nathalie Lenne, vice president (VP) of Strategic Portfolio Management at Domain Therapeutics, said: “ASCO 2025 has showcased groundbreaking innovations, particularly in the strategic integration of immunotherapy in the earliest phases of cancer therapy. We are seeing compelling data supporting the use of immunotherapy before and after surgery in early-stage cancers, with notable phase 3 in gastroesophageal junction tumors recently released. Treating early-stage patients is a crucial strategy, as immune activation before and after surgery improves survival and reduces recurrence rates.”
Another ASCO attendee who was “impressed” by the data presented at the event was Volker Wagner, chief medical officer (CMO) of French company Orano Med.
“With better understanding of tumor biology comes the opportunity for refined, more specific treatment options,” said Wagner. “Immuno-oncology remains a particular area of interest, with efforts aimed at increasing the percentage of patients who benefit from these therapies and exploring ways how ‘cold’ tumors could turn ‘hot.’”
This year, personalized vaccines continued their reign at ASCO.
“Personalized cancer vaccines are expanding rapidly, too – particularly with mRNA vaccines showing promise against certain cancers like glioblastoma and melanoma,” said Khan.
French company OSE Immunotherapeutics’ results of its cancer vaccine shone in a pancreatic cancer trial. Tedopi induced a 65% overall survival rate after 12 months. Around 26% patients in the drug cohort experienced serious adverse events, out of which 6% were found to be linked to Tedopi. No new safety signals were reported.
ASCO 2025: can’t get enough of ADCs
Meanwhile, antibody-drug conjugates (ADCs) were all the rage this year. These are drugs that combine a monoclonal antibody with chemotherapy to specifically target tumor cells and minimize the damage to healthy cells.
“Over 25 years, ADCs have transformed from a bold concept into a cornerstone of precision oncology: first revolutionizing the treatment of blood cancers and now redefining outcomes in solid tumors. Today’s next-generation ADCs, with smarter linkers, novel payloads, and higher drug-antibody ratios, are pushing the boundaries of targeted therapy. ADCs have also evolved into more sophisticated approaches with bi- or multispecifics and immune-engaging strategies, so we’re not just treating cancer – we’re engineering a future where therapies are more personal, potent, and precise,” said Daejin Abidoye, vice president, therapeutic area head for Solid Tumor Oncology at AbbVie.
Results from a non-small cell lung cancer (NSCLC) study of the pharma giant’s ABBV-400, which is a c-Met directed ADC, were presented at ASCO. A 63% monotherapy response rate was shown in EGFR-mutated non-squamous NSCLC, revealed Ross Camidge, from the University of Colorado Cancer Center and the principal investigator of the phase 1 trial.
Moreover, in neuroendocrine cancers, traditionally a patient population without many treatment options, ABBV-706 showed a “manageable safety profile and encouraging anti-tumor activity,” even in patients who have received multiple prior lines of therapy.
“These results are promising and suggest that ABBV-706 may serve as a new therapeutic option for patients without many standard treatment possibilities,” said Alissa Cooper, assistant attending physician of Thoracic Oncology Service at the Memorial Sloan Kettering Cancer Center and principal investigator of another phase 1 trial.
Another ADC that stole the show was Gilead-owned Trodelvy. In combination with Keytruda, it could become a new front-line standard of care, as doctors have called it “practice-changing.” At ASCO, it was revealed that the two therapies together slashed the risk of disease progression by 35% in PD-L1-positive triple-negative breast cancer (TNBC).
The median progression-free survival (PFS) was 11.2 months as opposed to 7.8 months in the chemotherapy-Keytruda cohort.
Ethan Smith, therapy area director for Oncology at Norstella, expressed that ADCs are “becoming established standards of care” across solid tumors.
“Pioneers such as Enhertu (HER2) are redefining treatment standards in breast cancer and provide new options for patients with low biomarker expression levels,” said Smith. “Future directions for ADCs look to combine with other immunotherapy modalities (e.g., PD-1), and early-stage trials are investigating novel approaches such as bispecific ADCs and dual-payload ADCs.”
Smith pointed towards the Enhertu-pertuzumab combination, which has been trialed, with results presented at the convention. The therapy demonstrated significant improvements in PFS for people with HER2+ breast cancer in the first-line setting, “marking the first improvement over standard of care in 10 years and a foray for an ADC into a frontline setting.”
Cell therapies at ASCO 2025: what were the takeaways?
Furthermore, cell therapies made up a lot of the talk. Labiotech heard from Mythili Koneru, CMO of Legend Biotech, developers of CARVYKTI, about the therapy’s progress since it nabbed FDA approval three years ago.
Findings from an ongoing phase 1b/2 study in relapsed refractory multiple myeloma (RRMM) were presented at ASCO 2025. About 33% of patients remained progression-free for five years or more following a single infusion of the CAR-T therapy with no maintenance or additional myeloma therapy. Koneru said that this was “an unprecedented milestone in the history of multiple myeloma treatment.” The company plans to increase manufacturing to meet growing demand over the drug.
Other cell therapy developers that presented at ASCO 2025 were Kite Pharma and Immatics. The latter’s cell therapy PRAME has been linked to a 56% objective response rate (ORR) among 32 heavily pretreated patients with metastatic melanoma, and Kite’s CAR-T drug hit the primary endpoint in a phase 1 study in patients with advanced B-cell lymphoma.
Although cell therapies make up a big part of cancer R&D, there are several challenges that pose to its development. Calling it “uncharted territory,” Medable’s CMO Pamela Tenaerts said that it has an access problem. This is partly because of the FDA-required 15-year follow-up for patients on the therapy to track adverse side effects.
“Not only is this burdensome and costly for patients but it is also incredibly expensive for drug sponsors who cannot reap financial gain over decades,” said Tenaerts, who thinks that the solution to this issue lies in the way clinical trials are designed.
AI-enabled clinical trial model premieres at ASCO 2025
That’s where digital clinical trial models could prove efficient, she added. Medable debuted its artificial intelligence-powered model at ASCO, which is meant to better monitor patients through virtual visits and a straightforward workflow that transitions patients from trials to observational follow-up.
“Instead of returning to a site thousands of miles away from home, patients can manage follow-ups remotely and engage with local physicians and labs. A patient’s entire medical team stays connected and updated because we bring the trial to the patient, not the other way around. Now, rather than drug sponsors foregoing important cell and gene therapy (CGT) trials and patients missing out on the potential for curative treatments for cancer and other diseases, or patients dropping out of a trial because the extensive follow-up is unsustainable, digital technologies enable remote and localized follow-up for everyone at a much lower cost,” said Tenaerts.
Clinical data at ASCO: radiopharmaceuticals and small molecules in the making
While ASCO buzzed with talk of immunotherapies and ADCs in the clinic, radiopharmaceuticals and small molecules weren’t left out. One radiopharmaceutical company that took part in ASCO was Orano Med. Labiotech spoke to Wagner about where he thinks radiopharmaceuticals are headed.
With several compounds now approved, radioligand therapies are established as a new treatment modality in oncology, that is here to stay and that will further expand,” said Wagner. “Following the theranostic approach, imaging is increasingly used to confirm target expression and for patient selection. Interest in targeted alpha therapy remains very strong, as alpha emitters combine potency, i.e., high linear energy transfer, with the promise to better protect healthy tissues due to their short path length.”
However, scientific innovation alone is not enough to be successful in the space, he added. “While many players, both big pharma and biotech, have engaged in radioligand therapies, only those who can also reliably source their isotope payload and master manufacturing and the complex supply to the institutions where patients are treated will succeed,” said Wagner.
The radiopharma strives to do this with its cancer-targeting therapy lead-212, as it has “secure access” to it and experience in manufacturing it. Lead-212 is in the clinic to treat a range of solid tumors, including small cell lung cancer (SCLC) and prostate cancer.
Meanwhile, in treating blood cancers, small molecule companies like Ascentage Pharma stood out. The Maryland-based biotech’s lisaftoclax is a BCL-2 inhibitor in phase 3 trials in the U.S.
“Our ASCO data for lisaftoclax represent a significant step forward in addressing the critical treatment gap for venetoclax-refractory patients,” said Dajun Yang, co-founder, chairman, and CEO of Ascentage Pharma.
In patients with blood cancers, such as myelodysplastic syndromes and chronic myelomonocytic leukemia (CMML), a 64% overall response rate (ORR) was reported. A complete response (CR) and marrow CR were achieved by 29% and 36% of patients, respectively. As for patients with relapsed or refractory acute myeloid leukemia (R/R AML) treated with lisaftoclax, the ORRs were 39% and 50% for 28 days or 14 days of repeated 28-day cycles, respectively.
“These data demonstrate that lisaftoclax can provide meaningful clinical benefit where other treatments have not been effective. This is exactly the kind of innovation the field needs, going beyond new drug development to target the resistance mechanisms that have long posed challenges for patients and to offer hope where none existed,” said Yang.
Ascentage also presented data of its lead small molecule olverembatinib, which has been approved in China.
Novel therapies: what’s new this year?
Biopharmas developing novel therapies also got their moment at ASCO 2025. California-based CERo Therapeutics employs what they call chimeric engulfment receptor (CER) T cells to engulf and kill cancer cells. Its lead preclinical candidate CER-1236 targets the TIM-4 ligand on tumor cells and damages these cells through both cytotoxic and phagocytic pathways. A dose-expansion study is planned for AML.
“The novelty of the CER technology that makes it stand out is the combination of targeting a unique ligand specific to abnormal malignant cells and engineering a new mode of tumor killing into the T cell. One of the major challenges in CAR-T therapy is finding a target that’s specific to the tumor cell and absent from healthy cells so that the T cells are directed at the tumor. The target of CER-1236, TIM-4-L, is really unusual in that healthy cells don’t express it on their surface, but malignant cells do, because it can have an immunosuppressive effect that benefits the cancer,” said CERo’s CEO Chris Ehrlich.
Moreover, the T cells have been engineered to perform phagocytic clearance – a way in which a cell ‘eats’ dead cells and pathogens in the body – of tumor cells, which has previously only been the purview of macrophages.
Other emerging therapies exhibited at ASCO include a KIF18A inhibitor called VLS-1488 and a first-in-class ADC named pivekimab sunirine (PVEK). VLS-1488 attacks kinesin protein, which aids in cell division. It is currently in phase 1/2 trials. As for PVEK, it addresses a rare, aggressive kind of blood cancer called blastic plasmacytoid dendritic cell neoplasm (BPDCN). It had an 85% ORR and 70% CRR in newly diagnosed patients with BPDCN. Researchers think it could be crowned as a new standard of care for these patients.
Another first-in-class therapy is INT230-6, a new formulation of the chemotherapies cisplatin and vinblastine and a tissue dispersion enhancer is undergoing phase 3 trials to target sarcomas, a type of cancer that develops in connective tissues. Developed by Connecticut-based Intensity Therapeutics, it is specifically designed for direct intratumoral injection.
“Intratumoral treatment efforts previously for cancer have been unsuccessful because the tumor often lacks blood vessels, is hard and dense, and often has a high fat content. Water-based products are naturally incompatible with the tumor’s internal environment. Intensity has a new chemistry that makes the company’s 100% water-based products compatible with the tumor microenvironment,” said Intensity’s CEO Lew Bender.
A poster of the trial in progress was presented at the gathering.
ASCO 2025 wrapped up yesterday with tens of thousands of people having attended. As the takeaways we’ve highlighted are just a drop in the ocean compared to the numerous therapeutic advancements that were discussed, it is fair to say that although immunotherapies and ADCs reigned supreme, several up-and-coming and novel cancer therapies are ones to watch out for in the years to come.
Oncology R&D trends and breakthrough innovations
