ALEXANDRIA, Va. – Twenty studies exploring a wide range of topics across many cancer disease sites will be presented at the upcoming 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago, IL, and online, June 2-6.

ASCO Experts in multiple disease areas are available to provide outside commentary and perspective on the studies below. Contact the ASCO Media Team to schedule an interview.

Abstract LBA506: 3-year invasive disease-free survival (iDFS) of the strategy-based, randomized phase II PHERGain trial evaluating chemotherapy (CT) de-escalation in human epidermal growth factor receptor 2-positive (HER2[+]) early breast cancer (EBC).
Abstract presentation part of session beginning at 2:45 p.m. CT on Friday, June 2.
“Among chemotherapy-free patients treated with trastuzumab and pertuzumab (group B with PET response and pathologic complete response), three-year invasive disease-free survival was 98.8%. This strategy identifies about one in three patients with HER2[+] early-breast cancer who can safely omit chemotherapy with significantly reduced toxicity,” said lead study author Javier Cortes.

Abstract 5015: A prospective trial of apalutamide and abiraterone acetate plus prednisone in Black and White men with metastatic castrate-resistant prostate cancer.
Abstract presentation part of session beginning at 8:00 a.m. CT on Saturday, June 3.

Abstract LBA100: KEYNOTE-671: Randomized, double-blind, phase 3 study of pembrolizumab or placebo plus platinum-based chemotherapy followed by resection and pembrolizumab or placebo for early-stage NSCLC
Please note: The full abstract will not be publicly available until 7:00 a.m. CT on June 3 and is embargoed until that time. Credentialed reporters can use the embargoed abstract search tool to view beforehand.
Abstract presentation part of session beginning at 8:00 a.m. CT on Saturday, June 3.
“These results indicate the peri-operative pembrolizumab given in combination with chemotherapy prior to surgery and for up to one year as a single agent after surgery led to significant improvement in event-free survival (defined by local progression precluding definitive surgery, recurrence, or death) with a strong trend towards improvement in overall survival.  These results indicate peri-operative pembrolizumab significantly improves outcomes for patients with potentially resectable stage II-III NSCLC,” said lead study author Heather Wakelee, MD, FASCO.

Abstract 5503: Dostarlimab for primary advanced or recurrent (A/R) endometrial cancer (EC): Outcomes by blinded independent central review (BICR) of the RUBY trial (ENGOT-EN6-NSGO/GOG-3031/RUBY).
Abstract presentation part of session beginning at 3:00 p.m. CT on Saturday, June 3.
"The results from the RUBY trial mark a milestone in the treatment of advanced or recurrent, mismatch repair deficient endometrial cancer. The addition of dostarlimab to the standard regimen of paclitaxel and carboplatin resulted in a drastic reduction in the risk of disease progression. Given the rising incidence and mortality of endometrial cancer, particularly among minority women, this finding represents a significant and transformational advancement,” said ASCO Expert Kathleen Moore, MD, MS.

Abstract 6509: Strategies to increase accrual of underrepresented populations in Alliance NCTN trials.
Abstract presentation part of session beginning at 1:15 p.m. CT on Saturday, June 3.
“Using a multi-pronged approach to increase accrual of racial and ethnic minority patients with cancer to clinical trials, the Alliance for Clinical Trials Network achieved a substantial increase in participation. This overwhelmingly successful approach not only reiterates the efficacy of multi-pronged approaches but also underscores that inclusivity in clinical research can be easily integrated into most clinical trial settings,” said Julie R. Gralow, MD, FACP, FASCO, Chief Medical Officer and Executive Vice President of ASCO.

“Intentional approaches to increase the accrual of underrepresented minorities (URM) to Alliance trials resulted in increased accrual from 13.6% to 25.3% for treatment and 13% to 21.5% for cancer control trials during 2018-2023. This reflects an overall increase from 13.5 % to 23.6% of URMs for all trials, a 74.8% improvement. With more diversity in clinical trials, we can make the results of trials representative of (and applicable to) all patients,” said lead study author Electra D. Paskett, PhD.

Abstract 4023: Neoadjuvant hepatic arterial infusion chemotherapy with FOLFOX could improve outcomes of resectable BCLC stage A/B hepatocellular carcinoma patients beyond Milan criteria: A multi-center, phase 3, randomized, controlled clinical trial.
Abstract presentation part of session beginning at 11:30 a.m. CT on Monday, June 5.
“We found that for resectable BCLC stage A/B hepatocellular carcinoma patients beyond Milan criteria, neoadjuvant hepatic arterial infusion chemotherapy with FOLFOX regimen could result in satisfactory objective response rates and disease control rates, and could also significantly improve the overall and recurrence-free survival of patients compared to direct surgery. This result means that neoadjuvant hepatic arterial infusion chemotherapy can be an effective and safe approach to bring better prognosis for this group of patients who have been previously considered to have limited benefit from surgery and provides evidence for more relevant studies in the future,” said lead study author Wei Wei, MD, PhD.

“The results of this phase III study show that combining neoadjuvant hepatic arterial infusion chemotherapy (HAIC) with FOLFOX can lead to improved progression-free and overall survival and has minimal complications for patients with early-stage resectable hepatocellular carcinoma (HCC). These findings have the potential to change how we treat HCC, offering new options for patients, a significant step toward improving outcomes and redefining the standard of care,” said ASCO Expert Glenn Hanna, MD.

Abstract LBA5000: Prostate irradiation in men with de novo, low-volume, metastatic, castration-sensitive prostate cancer (mCSPC): results of PEACE-1, a phase 3 randomized trial with a 2x2 design.
Please note: The full abstract will not be publicly available until 7:00 a.m. CT on June 4 and is embargoed until that time. Credentialed reporters can use the embargoed abstract search tool to view beforehand.
Abstract presentation part of session beginning at 8:00 a.m. CT on Sunday, June 4.
"The phase III PEACE-1 trial yielded valuable insights, confirming the results of previous trials such as HORAD and STAMPEDE, that radiation to the prostate does not improve overall survival in patients with de novo, low-volume, metastatic, castration-sensitive prostate cancer. However, the best outcomes were observed when radiation was alongside the standard of care and abiraterone. This suggests that the role of radiation, while not definitive in overall survival, may still be an important element in a more comprehensive, personalized treatment approach,” said ASCO Expert Bradley McGregor, MD.

Abstract 1501: Large-scale observational prospective cohort study of a multi-cancer early detection (MCED) test in symptomatic patients referred for cancer investigation.
Abstract presentation part of session beginning at 1:15 p.m. CT on Saturday, June 3.
“The test could speed up the diagnostic process for patients with symptoms of cancer by focusing cancer investigations on the cancer site of origin, identifying patients not usually referred for cancer investigation, and reducing unnecessary referrals for cancer investigation.,” said lead study author Associate Professor Brian D. Nicholson.

"The results of this study highlight the current limitations of blood testing for ctDNA in diagnosing occult cancer. While the concept of enhanced screening is appealing, the technology is still in its early developmental stages, lacking the necessary accuracy and clinical utility to benefit patients and providers. Despite its non-invasive nature, the ctDNA assay examined in this study falls short in terms of sensitivity and predictive value, rendering it unsuitable for diagnostic purposes. Further research and refinement are essential before this test can be considered a valuable tool in detecting hidden cancers,” said ASCO Expert Erica Mayer, MD, MPH.

Abstract LBA3503: Phase III randomized clinical trial comparing the efficacy of neoadjuvant chemotherapy and standard treatment in patients with locally advanced colon cancer: The NeoCol trial.
Please note: The full abstract will not be publicly available until 7:00 a.m. CT on June 4 and is embargoed until that time. Credentialed reporters can use the embargoed abstract search tool to view beforehand.
Abstract presentation part of session beginning at 8:00 a.m. CT on Sunday, June 4.
“We found no difference in the effect from neoadjuvant chemotherapy followed by surgery compared to the standard upfront surgery followed by adjuvant chemotherapy in patients with locally advanced colon cancer. Neoadjuvant chemotherapy is a safe treatment compared to upfront surgery. Taken together with the newly published results from the FOxTROT trial, patients now have a real choice between the traditional upfront surgery and neoadjuvant chemotherapy. Effect and safety is at least as favorable, and patient preference can be included in the individual treatment plan,” said lead study author Lars Henrik Jensen, MD, PhD.

Abstract 10001: Irinotecan and temozolomide combined with dasatinib and rapamycin for patients with relapsed or refractory neuroblastoma: Results of the prospective randomized RIST trial.
Abstract presentation part of session beginning at 9:45 a.m. CT on Sunday, June 4.
"The RIST trial’s findings underline the significant impact of adding dasatanib and rapamycin to the standard irinotecan and temozolomide treatment for high-risk, relapsed or refractory neuroblastoma. Not only was progression-free survival doubled in an intention-to-treat analysis, but overall survival was extended, particularly among the mycn+ cohort, without adding extra toxicity. This method offers a promising new salvage regimen for this high-risk disease,” said ASCO Expert Heather Symons, MD, MHS

Abstract 8510: Preliminary results from the Female Asian Nonsmoker Screening Study (FANSS).
Abstract presentation part of session beginning at 11:30 a.m. CT on Monday, June 5.
“Preliminary results from the Female Asian Nonsmoker Screening Study demonstrate that a lung cancer screening program in a population that does not smoke cigarettes is feasible. Although we are reporting on small numbers thus far, our study shows an early snapshot of a lung cancer detection rate of 1.5% which appears to be on par with what has been seen in a large-scale screening study conducted for nonsmokers in Taiwan. Expanding lung cancer screening to other populations beyond those who smoke cigarettes, such as those who do not smoke, are warranted given increased treatment options in the early-stage lung cancer setting, such as the approval of adjuvant osimertinib from the ADAURA study. We hope this study will help to address the need for screening efforts in those who do not smoke, as many are unfortunately diagnosed with stage IV lung cancer due to lack of screening,” said lead study author Elaine Shum, MD.

Abstract 12015: Effect of flibanserin on libido in women with breast cancer on adjuvant endocrine therapy.
Abstract presentation part of session beginning at 1:15 p.m. CT on Monday, June 5.
“While we continue to make strides in the treatment of breast cancer, the side effects, especially sexual dysfunction in younger women, often remain unaddressed in the clinical setting. This study offers an insight into the role of flibanserin in tackling this sensitive but common issue, showing an improvement in sexual dysfunction in patients taking the medication. Although the findings are based on a small cohort, they serve as a catalyst for a larger, robust, and comprehensive study to further examine the potential of this agent in improving the overall well-being of breast cancer patients,” said ASCO Expert Erica Mayer, MD, MPH.

Abstract 6009: Final overall survival analysis of JUPITER-02: A phase 3 study of toripalimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (NPC).
Abstract presentation part of session beginning at 1:15 p.m. CT on Monday, June 5.
“The prespecified final overall survival analysis of JUPITER-02 study showed that the addition of toripalimab to chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma provided significantly better and clinically meaningful improvement in overall survival than chemotherapy alone, independent of PD-L1 expression status. The addition of toripalimab to first-line chemotherapy reduced the chance of death by 37% than chemotherapy alone and improved the three-year survival rate to 64.5%. Toripalimab plus gemcitabine-cisplatin chemotherapy represents a new standard of care for this patient population,” said lead study author Haiqiang Mai.

Abstract LBA107: Primary overall survival analysis of the phase 3 randomized ZUMA‑7 study of axicabtagene ciloleucel versus standard‑of‑care therapy in relapsed/refractory large B-cell lymphoma.
Please note: The full abstract will not be publicly available until 7:00 a.m. CT on June 5 and is embargoed until that time. Credentialed reporters can use the embargoed abstract search tool to view beforehand.
Abstract presentation part of session beginning at 9:45 a.m. CT on Monday, June 5.
“In a randomized global phase 3 trial, we found that patients with refractory or early relapsed large B-cell lymphoma who were treated with axi-cel, a CAR T-cell therapy, as second-line treatment had a 27.4% reduction in the risk of death compared with the previous standard of chemotherapy and stem cell transplant. The results of the Primary Overall Survival Analysis of the ZUMA-7 trial mean that more patients live longer with second-line axi-cel compared with the previous standard of care, and that axi-cel should be a second-line treatment instead of trying chemotherapy first and saving CAR T-cell therapy for patients who do not respond. We believe our data represent a paradigm shift, and mean that patients should be referred to a CAR T-cell center for an evaluation before starting chemotherapy,” said lead study author Jason Westin, MD, MS, FACP.

Abstract 4508: SWOG S1011: A phase III surgical trial to evaluate the benefit of a standard versus an extended lymphadenectomy performed at time of radical cystectomy for muscle invasive urothelial cancer.
Abstract presentation part of session beginning at 11:30 a.m. CT on Monday, June 5.

Abstract 10027: Efficacy and safety of pembrolizumab (pembro) in children and young adults with newly diagnosed classical Hodgkin lymphoma (cHL) with slow early response (SER) to front-line chemotherapy (chemo) in the phase 2, open-label, KEYNOTE-667 study.
Abstract presentation part of session beginning at 8:00 a.m. CT on Sunday, June 4.
"The KEYNOTE-667 study reveals that for children and young adults who have Hodgkin lymphoma and a slow early response to chemotherapy, adding pembrolizumab as consolidation and maintenance therapy is a promising strategy. By augmenting responses and sparing the need for radiation, it holds potential in mitigating relapse risks, though we acknowledge further follow-up is necessary to establish its long-term efficacy,” said ASCO Expert Melissa Hudson, MD.

Abstract LBA9000: Pemetrexed and platinum with or without pembrolizumab for tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutant, metastatic nonsquamous NSCLC: Phase 3 KEYNOTE-789 study.
Please note: The full abstract will not be publicly available until 7:00 a.m. CT on June 6 and is embargoed. Credentialed reporters can use the embargoed abstract search tool to view beforehand.
Abstract presentation part of session beginning at 9:45 a.m. CT on Tuesday, June 6.
“The findings of the KEYNOTE-789 study have significant implications for clinical practice. Many community oncologists had generalized the results of the Keynote 189 trial to all patient populations, but this study clearly demonstrates that chemo-immunotherapy is not suitable for EGFR+ NSCLC patients after progression on osimertinib. Immediate changes in patient care are necessary to avoid unnecessary toxicity and focus on more effective treatment strategies,” said ASCO Expert Jyoti D. Patel, MD.

ASCO Research to be Presented During 2023 ASCO Annual Meeting

Abstract 3115: Talazoparib (Tala) in patients (pts) with solid tumors with BRCA1/2 mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.
Abstract presentation part of session beginning at 8:00 a.m. CT on Saturday, June 3.
“ASCO’s TAPUR Study results reveal talazoparib as a potential treatment option beyond its current FDA-approved indications, showing strong responses and disease control in heavily pretreated patients with various cancers with BRCA1/2 mutations. If these findings are confirmed in larger studies, this could mean a new treatment avenue for patients with hard-to-treat diseases that lack effective options. Further validation through larger studies is essential to confirm these promising findings,” said lead author Gordan Srkalovic, MD.

Abstract 3117: Temsirolimus (T) in patients (pts) with solid tumors with PIK3CA mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.
Abstract presentation part of session beginning at 8:00 a.m. CT on Saturday, June 3.
“Part of ASCO’s TAPUR study, these cohorts evaluated the role of temsirolimus in patients with PIK3CA-mutated advanced solid tumors, shedding light on the potential use of this targeted therapy in other cancers. While the disease control rate in patients with breast cancer was not significant, it was 29% for those with other solid tumors, with a remarkable response seen particularly in a patient with heavily pretreated ovarian cancer with otherwise poor prognosis. These results underscore the importance of comprehensive molecular testing, such as next-generation sequencing, which can yield new treatment opportunities for patients,” said lead study author Carmen Calfa, MD.

Abstract 5548: Nivolumab plus ipilimumab (N+I) in patients (pts) with ovarian cancer (OC) with BRCA1/2 mutation (mut): Results from the Targeted Agent and Profiling Utilization Registry (TAPUR) study.
Abstract presentation part of session beginning at 1:15 p.m. CT on Monday, June 5.
“The combination therapy of nivolumab and ipilimumab achieved a disease control rate of 27% in patients with recurrent ovarian cancer and BRCA1/2 mutations in the ASCO TAPUR study. Although the criteria for antitumor activity were not met overall, the observation of partial responses, with some lasting over 62 weeks, supports further investigation into predictive biomarkers for response to this treatment combination,” said lead study author Charles Drescher, MD.

View the disclosures for the 2023 Cancer Communications Committee: https://old-prod.asco.org/sites/new-www.asco.org/files/content-files/about-asco/pdf/2023-AM-CCC-Disclosures.pdf

View the disclosures for Dr. Gralow

ATTRIBUTION TO THE AMERICAN SOCIETY OF CLINICAL ONCOLOGY ANNUAL MEETING IS REQUESTED IN ALL COVERAGE.

###