ASCO 2025: Key Anticipated Updates Across Cancer Care

One abstract of interest in the gynecologic malignancy space is a late-breaking abstract unveiling findings from the phase 3 ROSELLA trial (NCT05257408) assessing relacorilant in combination with nab-paclitaxel for those with platinum-resistant ovarian cancer.

With the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting rapidly approaching, CancerNetwork^® reached out to researchers and clinicians with expertise across a variety of disease types about the data that may transform certain standards of care. On top of a deep dive into several noteworthy studies in breast cancer, gastrointestinal malignancies, and head and neck cancers, experts shared their perspectives on the late-breaking abstracts, plenary sessions, and oral abstracts with key clinical implications in gynecologic diseases, hematologic malignancies, and other treatment fields.

Here is a sample of potentially standout sessions across oncology at this year’s ASCO meeting:

LBA5507: ROSELLA: A phase 3 study of relacorilant in combination with nab-paclitaxel versus nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer (GOG-3073, ENGOT-ov72).

Presentation: June 2, 10:00 – 10:12 AM CDT by Alexander Olawaiye, MD, FACOG, FACS

One abstract of interest in the gynecologic malignancy space is a late-breaking abstract unveiling findings from the phase 3 ROSELLA trial (NCT05257408) assessing relacorilant in combination with nab-paclitaxel for those with platinum-resistant ovarian cancer.

In March 2025, developers announced that the relacorilant-based regimen reached the study’s primary end point of progression-free survival (PFS).¹ Topline data showed a median PFS of 6.5 months per blinded independent central review with the relacorilant combination vs 5.5 months with nab-paclitaxel alone, demonstrating a 30% decrease in the risk of disease progression or death (HR, 0.70; P = .008). Interim overall survival (OS) data indicated a median OS of 16.0 months vs 11.5 months in each respective arm (HR, 0.69; P = .012).

At the time of analysis, relacorilant was well tolerated among patients, and investigators identified no new safety signals.

“A phase 2 study [NCT05257408] had shown promising results in [PFS] and [OS] for those patients who were treated with intermittent relacorilant in combination with nab-paclitaxel.² I've seen a press release that says that the phase 3 study was a positive study, but those data are being presented at ASCO this year,” Rachel N. Grisham, MD, section head of Ovarian Cancer and director of Gynecologic Medical Oncology at MSK Westchester of Memorial Sloan Kettering Cancer Center, said in an interview with CancerNetwork. “I’m excited to see what that data shows and if that potentially represents a new opportunity for our patients with [platinum-resistant] ovarian cancer.”

7507: Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM).

Presentation: June 3, 11:57 AM – 12:09 PM CDT by Peter M. Voorhees, MD

CancerNetwork reached out to Rahul Banerjee, MD, FACP, an assistant professor in the Clinical Research Division at the Fred Hutchinson Cancer Center in Seattle, Washington, regarding crucial developments in hematologic oncology that one could expect to see at this year’s ASCO meeting. In the multiple myeloma space, Banerjee noted an update on long-term data from the phase 1b/2 CARTITUDE-1 study (NCT03548207, NCT05201781) assessing ciltacabtagene autoleucel (cilta-cel; Carvykti) for those with heavily pretreated relapsed/refractory disease.

According to a press release from the developer, this session will highlight updated OS results and 5-year and longer PFS outcomes after a median follow-up of 60.3 months.³ Of note, patients who remained progression-free and alive during this period received no additional therapy for their disease beyond a single infusion of cilta-cel.

7505: First-in-human study of JNJ-79635322 (JNJ-5322), a novel, next-generation trispecific antibody (TsAb), in patients (pts) with relapsed/refractory multiple myeloma (RRMM): initial phase 1 results.

Presentation: June 3, 11:09 – 11:21 AM CDT by Niels W.C.J. van de Donk, MD, PhD

Banerjee also spotlighted a session that will unveil first-in-human results related to the use of JNJ-79635322 (JNJ-5322) for patients with relapsed/refractory multiple myeloma in a phase 1 study (NCT05652335).

Investigators previously outlined the novel trispecific antibody’s design and mechanism of action as a potential therapeutic strategy for multiple myeloma at the 2023 American Society of Hematology Annual Meeting & Exposition (ASH).⁴ The agent features an anti-CD3 binding domain, an anti-BCMA binding domain, and an anti-GPRC5D binding domain. Preclinical findings demonstrated JNJ-5322 as a potential first-in-class therapy with the ability to deplete multiple myeloma clones with dual and single target expression.

Initial data from the first-in-human phase 1 study may highlight the utility of trispecific therapy for this multiple myeloma population.

11506: A randomized phase III trial of catequentinib hydrochloride (AL3818) versus placebo in subjects with metastatic or advanced leiomyosarcoma (LMS).

Presentation: June 1, 11:45 – 11:57 AM CDT by Robin Lewis Jones, MD, BSc, MBBS, MRCP

Brian A. Van Tine, MD, PhD, a professor of medicine and pediatrics and a medical oncologist at Siteman Cancer Center of Washington University in St. Louis, connected with CancerNetwork to discuss key updates in the management of different sarcomas. He identified a presentation on findings from theevaluating treatment with catequentinib hydrochloride (AL3818) as a notable development in metastatic or advanced leiomyosarcoma.

According to Van Tine, this trial features a few arms focusing on different sarcoma populations. At the 2021 ASCO Annual Meeting, he presented results from another arm assessing AL3818 vs dacarbazine among patients with synovial sarcoma who required second-line or later therapy.⁵ Findings from that presentation showed improvements in disease control and PFS with AL3818 compared with dacarbazine, supporting the novel therapy as a potentially meaningful option for those with advanced synovial sarcoma.

Updated results from the phase 3 study may also position AL3818 as a therapeutic strategy for patients with metastatic or advanced leiomyosarcoma.

“There is this drug that now seems to have activity both in synovial [sarcoma] and leiomyosarcoma,” Van Tine stated. “We now have the appearance of a second signal for catequentinib, which is a well-tolerated tyrosine kinase inhibitor that has fewer liver issues and a better toxicity profile than pazopanib [Votrient], appearing now for a broader range of sarcomas.”

LBA8000: Overall survival with neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) in patients with resectable NSCLC in CheckMate 816.

Presentation: June 2, 3:00 – 3:12 PM CDT by Patrick M. Forde, MD, PhD

Regarding key updates in the lung cancer field, Eric K. Singhi, MD, assistant professor in the Department of General Oncology in the Division of Cancer Medicine, and assistant professor in the Department of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center, highlighted the as one to look out for in the neoadjuvant treatment of patients with resectable non–small cell lung cancer (NSCLC). Results from this presentation will come from the arm assessing nivolumab (Opdivo) plus chemotherapy in the neoadjuvant setting.

Prior findings from the nivolumab plus ipilimumab (Yervoy) arm of the CheckMate-816 study were published in January 2025 in the Journal of Clinical Oncology.⁶ Published data showed a median event-free survival (EFS) of 54.8 months (95% CI, 24.4-not reached [NR]) with nivolumab/ipilimumab vs 20.9 months (95% CI, 14.2-NR) with chemotherapy alone (HR, 0.77; 95% CI, 0.51-1.15). Investigators concluded that neoadjuvant nivolumab plus ipilimumab demonstrated long-term benefit compared with chemotherapy alone in this population.

Furthermore, the 4-year update from the nivolumab/chemotherapy arm of CheckMate-816, which was presented at the 2024 ASCO Annual Meeting, showcased that the chemoimmunotherapy regimen elicited an enduring long-term EFS benefit and a trend towards improved OS vs chemotherapy alone.⁷ At the time of analysis, the median OS was NR with both nivolumab/chemotherapy and chemotherapy alone (HR, 0.71; 98.36% CI, 0.47-1.07; P = .0451). Updated results from this year’s presentation may further elucidate the OS benefit that nivolumab/chemotherapy could provide in this patient population.

8001: Neoadjuvant (neoadj) osimertinib (osi) ± chemotherapy (CT) vs CT alone in resectable (R) epidermal growth factor receptor-mutated (EGFRm) NSCLC: NeoADAURA.

Presentation: June 2, 3:12 – 3:24 PM CDT by Jamie E. Chaft, MD, FASCO

Another update that Singhi anticipated in the neoadjuvant lung cancer therapy setting related to the phase 3 NeoADAURA trial (NCT04351555) assessing osimertinib (Tagrisso) with or without chemotherapy for patients with NSCLC harboring EGFR mutations. As Singhi described, results may clarify what “the best strategy is” for treating this patient population prior to surgical resection.

According to the previously published clinical trial protocol, the study’s primary objective was assessing the benefit of osimertinib-based treatment on the centrally assessed major pathological response (MPR) rate at the time of resection.⁸ Findings from ASCO will highlight how the use of osimertinib impacts MPR as well as other end points such as downstaging at the time of resection, disease-free survival, and OS compared with chemotherapy alone.

“The results will help to further define the role of neoadjuvant targeted treatment, particularly neoadjuvant osimertinib treatment, in resectable [EGFR-mutated] NSCLC,” presenting author Jamie E. Chaft, MD, a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center and from the Department of Medicine at Weill Cornell Medical College, wrote with coauthors in the trial protocol.⁸ “The results of NeoADAURA have the potential to enrich the treatment options and inform clinical practice of neoadjuvant treatment in this setting.”

References

1. Primary endpoint met in Corcept’s pivotal phase 3 ROSELLA trial of relacorilant in patients with platinum-resistant ovarian cancer. March 31, 2025. Accessed May 27, 2025. https://tinyurl.com/y5ctdfbn
2. Colombo N, Van Gorp T, Matulonis UA, et al. Relacorilant + nab-paclitaxel in patients with recurrent, platinum-resistant ovarian cancer: a three-arm, randomized, controlled, open-label phase II study. J Clin Oncol. 2023;41(30):4779-4789. doi:10.1200/JCO.22.02624.
3. Legend Biotech announces new oncologic & hematologic therapeutic developments at ASCO, EHA, and ASGCT. News release. Legend Biotech Corporation. May 22, 2025. Accessed May 27, 2025. https://tinyurl.com/27d76d9c
4. Pillarisetti R, Yang D, Yao J, et al. Characterization of JNJ-79635322, a novel BCMAxGPRC5DxCD3 T-cell redirecting trispecific antibody, for the treatment of multiple myeloma. Blood. 2023;142(suppl 1):456. doi:10.1182/blood-2023-174941
5. Van Tine BA, Chawla SP, Trent JC, et al. A phase III study (APROMISS) of AL3818 (catequentinib, anlotinib) hydrochloride monotherapy in subjects with metastatic or advanced synovial sarcoma. J Clin Oncol. 2021;39(suppl 15):11505. doi:10.1200/JCO.2021.39.15_suppl.11505
6. Awad MM, Forde PM, Girard N, et al. Neoadjuvant nivolumab plus ipilimumab versus chemotherapy in resectable lung cancer. J Clin Oncol. 2025;43(12):1453-1462. doi:10.1200/JCO-24-02239
7. Spicer J, Girard N, Provencio M, et al. Neoadjuvant nivolumab (NIVO) + chemotherapy (chemo) vs chemo in patients (pts) with resectable NSCLC: 4-year update from CheckMate 816. J Clin Oncol. 2024;42(suppl 17):LBA8010. doi:10.1200/JCO.2024.42.17_suppl.LBA8010
8. Tsuboi M, Weder W, Escriu C, et al. Neoadjuvant osimertinib with/without chemotherapy versus chemotherapy alone for EGFR-mutated resectable non-small-cell lung cancer: NeoADAURA. Future Oncol. 2021;17(31):4045-4055. doi:10.2217/fon-2021-0549