Late-breakers to look out for at ASCO 2026

ASCO is just around the corner, and as usual, there is a fertile crop of high-profile clinical trials to look out for among the late-breaker presentations.

To follow – and in no particular order - are some of the highlights of the pivotal studies scheduled to reveal new data at the flagship US cancer congress.

EMERALD-3: AstraZeneca is pitching to move its combination of PD-L1 inhibitor Imfinzi (durvalumab) and CTLA4 inhibitor Imjudo (tremelimumab) into the first-line setting for people living with hepatocellular carcinoma (HCC), the most common form of liver cancer. The EMERALD-3 study is evaluating the regimen as an add-on to transarterial chemoembolisation (TACE), a commonly used minimally invasive treatment for liver cancer, that typically only controls the cancer for six to 10 months before it returns.

POTOMAC: AZ is also hoping to extend the use of Imfinzi into non-muscle invasive bladder cancer (NMIBC) from its current first-in-class approval for peri-operative treatment of muscle-invasive bladder cancer (MIBC), and will be revealing five-year results from the POTOMAC trial of Imfinzi plus BCG induction and maintenance therapy for NMIBC, with a reduced risk of recurrence compared to BCG alone. Imfinzi is currently under regulatory review for NMIBC, and bladder cancer is viewed by the company as a major new opportunity to grow the drug commercially.

OptimUM-02: Ideaya/Servier's PKC inhibitor darovasertib, given in combination with Pfizer's cMET inhibitor Xalkori (crizotinib), could break new ground in the treatment of uveal melanoma, a rare aggressive cancer of the eye with few treatment options, with the OptimUM-02 study. The regimen could offer a targeted treatment for a group of patients with the cancer that cannot be treated with the current go-to treatment, Immunocore's Kimmtrak (tebentafusp), used to treat HLA-A*02:01-positive cases. At the moment, there are no approved therapies for patients who test negative for the biomarker.

RASolute 302: Any drug showing efficacy in pancreatic cancer is an important development, given that it is aggressive, highly resistant to standard therapies, and extremely difficult to detect in its early stages. RASolute 302 is testing Revolution Meds' pan-RAS(on) inhibitor daraxonrasib as a second-line treatment for metastatic pancreatic ductal adenocarcinoma (PDAC) in the study, after standard chemotherapy. Revolution has already revealed that daraxonrasib was able to extend survival compared to second-line chemo, and the drug's promise in this most common form of pancreatic cancer has earned it a super-speedy national priority review from the FDA.

SUCCESSOR-2: Bristol Myers Squibb has invested heavily in its oral cereblon E3 ligase modulator (celmod) pipeline, and there will be a lot of interest in SUCCESSOR-2, the first phase 3 readout for mezigdomide as an add-on to Amgen's Kyprolis (carfilzomib) and dexamethasone given second-line for patients with relapsed or refractory multiple myeloma. Mezigdomide was highlighted in IQVIA's new drugs to watch in 2026 report as a $1.5 billion blockbuster, designed to be more potent and effective at killing myeloma cells and activating the immune system than older immunomodulatory drugs like BMS Revlimid (lenalidomide) and Pomalyst (pomalidomide), now facing generic competition.

PROTEUS: A presentation on Johnson & Johnson's Erleada (apalutamide) will open the ASCO plenary, with the results of the PROTEUS study promising a 'paradigm shift' in high-risk, localised or locally advanced prostate cancer. The trial is comparing Erleada to placebo, given on top of androgen deprivation therapy (ADT) and radical prostatectomy, and is attempting to build on the results of the phase 2 Apa-RP study, which showed a 100% biochemical recurrence-free survival (RFS) rate at 24 months with J&J's drug, an androgen receptor inhibitor that has already become a mainstay of prostate cancer treatment. Global sales reached almost $3.6 billion last year in non-metastatic castration-resistant prostate cancer (CRPC) and metastatic castration-sensitive prostate cancer (CSPC). Localised prostate cancer is common, accounting for upwards of 85% of all cases at diagnosis, so the results could have far-reaching clinical consequences.

TALAPRO-3: Staying in the prostate cancer category, the TALAPRO-3 study of Pfizer's Talzenna (talazoparib) could take the PARP inhibitor class into uncharted territory. Already used to treat metastatic CRPC, TALAPRO-3 is the first phase 3 trial in earlier-stage metastatic CSPC patients, focusing on those with homologous recombination repair (HRR) mutations, and could give Talzenna a larger market free of competition from other drugs in the class like AZ/MSD's market-leading Lynparza (olaparib). Topline results reported previously pointed to an improvement in radiographic progression-free survival (rPFS) compared to placebo when added to treatment with Astellas/Pfizer's androgen receptor inhibitor Xtandi (enzalutamide).

MajesTEC-9: J&J's push to advance its BCMAxCD3 bispecific T-cell engager Tecvayli (teclistamab) into earlier lines of therapy for multiple myeloma – en route to what it reckons could be peak sales of $5 billion or more – looks set to get a big helping hand from the MajesTEC-9 trial, according to previously-revealed topline results. Monotherapy with Tecvayli as a second-line or later therapy reduced the risk of death compared to investigator's choice of current regimens. Haematologists will be looking closely at the data, to see if Tecvayli can move from a salvage therapy in heavily-pretreated patients to one more focused on relapse prevention earlier on in the course of the disease.

frontMIND: Another study seeking to move a treatment earlier in the pathway is frontMIND, which could underpin a move for Incyte's anti-CD19 antibody Monjuvi (tafasitamab) into treatment-naïve diffuse large B-cell lymphoma (DLBCL). The study, evaluating Monjuvi with Revlimid and a chemo regimen (R-CHOP), suggests that more patients can achieve functional cures for DLBCL compared to R-CHOP alone, which has been the standard treatment for around 20 years. The trial will form the basis of regulatory filings for Monjuvi in previously untreated DLBCL, potentially ramping up the sales potential of a drug that Incyte acquired from Morphosys for an upfront fee of just $25 million, just ahead of Morphosys' $2.9 billion sale to Novartis. Sales came in at around $145 million last year.

SARCO41: Dedifferentiated liposarcoma is an aggressive cancer with few treatment options, mainly chemo, but the placebo-controlled SARCO41 study could make Lilly's CDK4/6 inhibitor Verzenio (abemaciclib) the first targeted treatment for the disease, given that CDK4 is amplified in around 90% of patients with this aggressive type of cancer. An earlier mid-stage trial generated encouraging results, with improvements in PFS, as well as a significantly higher objective response rate.

HARMONi-6: Akeso and Summit Pharma's PD-1xVEGF bispecific antibody ivonescimab grabbed attention with data at last year's ESMO congress showing that it improved progression-free survival (PFS) compared to BeOne's PD-1 inhibitor Tevimbra (tislelizumab) on top of chemo in previously-untreated squamous non-small cell lung cancer (NSCLC) in HARMONi-06, having previously bested MSD's top-selling PD-1 drug Keytruda (pembrolizumab) in the HARMONi-02 trial. At ASCO, overall survival data is being presented that could consolidate the benefits of dual-acting PD-1 and CEGF agents in first-line NSCLC over the treatment standard.

LIBRETTO-432: Lilly's RET inhibitor Retevmo (selpercatinib) has become a go-to therapy for RET-mutated tumours, including lung and thyroid cancers, since it was first launched in 2020, with sales growing strongly as its label was extended to reach $456 million last year. The LIBRETTO-432 trial could move the drug into the adjuvant treatment setting in RET fusion-positive NSCLC, with Lilly reporting a top-line improvement in event-free survival compared to placebo in patients who have had surgery or radiation therapy. The results due to be presented at ASCO could establish Retevmo as a new standard-of-care for this type of lung cancer.

FIGHT-302: At the moment, patients diagnosed with metastatic biliary tract cancer (BTC, also known as cholangiocarcinoma) are generally treated with a backbone chemo regimen based on cisplatin and gemcitabine, and efforts to improve on this with additional agents have been unsuccessful. The FIGHT-302 trial could be the exception, as high-level results show that adding Incyte's FGFR inhibitor Pemazyre (pemigatinib) to the regimen in patients with FGFR fusion–positive cholangiocarcinoma led to a reduction in the risk of disease progression or death. The trial could lead to Pemazyre becoming the first drug in the FGFR inhibitor class to move into the first-line setting for this type of BTC.

VIKTORIA-1: Celcuity is hoping to make a splash in the PI3K inhibitor class with gedatolisib, which combines PI3K and mTOR inhibition in one molecule, in HR-positive, HER2-negative breast cancer. The drug is already filed for approval to treat PIK3CA wild-type breast cancer based on the VIKTORIA-1 trial, and Celcuity will reveal data at ASCO from another cohort of the study in patients with PIK3CA-mutant disease that has progressed on or after treatment with a CDK4/6 inhibitor and an aromatase inhibitor. If all goes to plan, gedatolisib could be approvable as a broadly-acting drug in both wild-type and mutant forms, while current PI3K inhibitors, such as Novartis' Piqray (alpelisib) and Roche's Itovebi (inavolisib), are only approved for PIK3CA-mutant disease.

OptiTROP-Lung05: Kelun-Biotech's TROP2-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT) – which is being developed outside China by MSD – looks set to make a splash in first-line NSCLC treatment with the results of the OptiTROP-Lung05, which is comparing the drug with Keytruda to Keytruda alone in patients with PD-L1-positive tumours. It is the first phase 3 trial to show a significant improvement in PFS and a positive trend in overall survival compared to Keytruda in this setting, and will form the basis of regulatory filings in China. The results will also be a boost to MSD, which licensed rights to the ADC four years ago in a deal valued at up to $1.4 billion and is running an extensive phase 3 programme for the drug across multiple tumour types, recently reporting positive data in endometrial cancer.