Virginia Seery, MSN, RN, ANP-BC, AOCNP1; Diane Andresen, MSN, APN-C, AOCNP2; Brenda Martone, MSN, ANP-BC, AOCNP3; Steven Lee-Ramos, MS, RN, AGACNP-BC4; Tasha Hall, PhD, RN5; Kiran Virdee, RN, BSN6
1Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; 2John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ; 3Robert H. Lurie Cancer Center, Northwestern Medicine, Chicago, IL; 4Gastrointestinal Medical Oncology Clinic, University of California San Francisco, San Francisco, CA; 5Exelixis, Inc., Alameda, CA; 6Memorial Sloan Kettering Cancer Center, New York, NY
Background: The tyrosine kinase inhibitor cabozantinib plus the immune checkpoint inhibitor nivolumab is approved for first-line treatment of advanced renal cell carcinoma (RCC) based on results of the CheckMate 9ER study (NCT03141177).1,2 Proactive management of adverse events (AEs) associated with this regimen allows longer treatment duration, potentially improving outcomes.
Objective: To discuss the management of common treatment- emergent AEs associated with cabozantinib plus nivolumab combination therapy, highlight the important role of oncology nurses in managing these events, and provide guidance and strategies to aid oncology nurses in their care of patients with advanced RCC.
Methods: Management of AEs with cabozantinib plus nivolumab relies on identification of the causative agent, which can be complex given that immune-mediated AEs associated with nivolumab may overlap with cabozantinib AEs (eg, gastrointestinal and dermatologic toxicities). We identified the most common AEs (all causality) resulting in dose delay, dose reduction, or study drug discontinuation in CheckMate 9ER. For these AEs, we then summarized the median time to onset, incidence (all grades, grades 3/4), and corresponding rates of dose delay or reduction and discontinuation (of any study drug in the cabozantinib plus nivolumab arm). Per study protocol, dose reduction of nivolumab was not allowed. The practicing oncology nurse authors summarized their supportive care strategies and the advice they provide to patients for the management of these key AEs, including assessment and management of overlapping toxicities with cabozantinib and nivolumab.
Results: In the cabozantinib plus nivolumab arm of CheckMate 9ER, the most frequent any-grade, all-causality (>10%) AEs resulting in dose modifications were diarrhea (24%), palmar-plantar erythrodysesthesia (19%), hypertension (11%), and elevations in alanine aminotransferase (10%) or aspartate aminotransferase (8%). Alanine aminotransferase and aspartate aminotransferase elevations were the most frequently reported AEs that led to discontinuation of either study drug (1.9% and 1.6%, respectively). Nurses play a key role in educating patients about common AEs, monitoring for signs and symptoms of AEs, implementing prophylaxis and supportive care (eg, lotions for skin-related AEs, use of antihypertensives, dietary changes for diarrhea), and overseeing dose modification and initiation of immunosuppressive therapy.
Conclusion: Cabozantinib plus nivolumab is an effective first-line treatment for advanced RCC. Oncology nurses are typically the first point of contact for patients experiencing AEs associated with cancer treatments and play an essential role in the management of these AEs. Proactive and comprehensive AE management helps to improve tolerability and may allow patients to remain on therapy, maximizing clinical benefit.
Study sponsor: Exelixis, Inc.
Dan Mulligan1; Amy Shaberman, PhD2; Jennifer Han, PharmD, MBA, BCOP2; Lars Stoltzfus, PhD3; Brandi Felser4
1Patient Advocate, La Jolla, CA; 2Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; 3Savvy Cooperative, Queens, NY; 4Sarcoma Foundation of America, Damascus, MD
Background: Liposarcomas (LPS) are rare tumors that are among the most common soft tissue sarcomas. Variable clinical presentation, prognosis, and treatment response for the LPS subtypes coupled with minimal changes to systemic therapy for soft tissue sarcomas since the 1970s highlight the challenges for patients in seeking accurate diagnosis and treatment.
Objective: Here we present interim results of a survey conducted to help understand the burden of LPS on patients in the United States (US), their diagnostic journey, and the impact on their quality of life (QOL).
Methods: Patients with LPS aged ≥18 years and residing in the US completed an online survey on their experiences with the diagnostic journey, burden of disease and treatment, QOL, and sources of support. Survey enrollment is ongoing. A descriptive statistical analysis was performed.
Results: Of 40 patients who completed the survey between August 4, 2023, and March 1, 2024, 83% were White, and 60% had employer-provided insurance. Collectively, patients consulted ≥7 types of specialists for initial symptoms/ concerns. First consultation was often with an internal medicine practitioner (n=16) or oncologist (n=10). Sixty percent were diagnosed by a surgeon or oncologist. Twelve patients were unsure of LPS stage at diagnosis (not discussed, n=8). At the time of completing the survey, 53% of patients were in remission (18% were unsure). Approximately 25% of patients traveled over 1.5 hours for treatment. Additionally, 25% reported treatment did not improve their QOL. Most frequently reported concerns were about physical condition (73%) and finances (53%). Overall, 55% of patients reported that LPS limited performing activities. Facebook groups and specialists were noted as support resources; most useful types of support were peer-to-peer support (48%), financial assistance (30%), and mental health resources (28%).
Conclusion: The interim findings of this survey underscore the challenges that patients with LPS face while navigating the healthcare system. Consultation of numerous specialists and travel time to receive treatment impact access to timely diagnosis and quality care. The impacts of LPS on QOL and finances were also key unmet needs experienced by patients, which supports an increase in QOL and financial support resources for patients. There is also a need for increased awareness among physicians about LPS and the impact on patients’ QOL as well as for effective treatments that improve QOL.
This abstract was submitted for presentation at the ASCO Quality Care Symposium, held September 27-28, 2024, in San Francisco, CA.
Aditya Bardia1; Joyce O’Shaughnessy2; Francois-Clement Bidard3; Phillipe Aftimos4; Javier Cortes5; Janice Lu6; Giulia Tonini7; Kathy Puyana Theall8; Alessandro Paoli9; Virginia Kaklamani10
1UCLA Health Jonsson Comprehensive Cancer Center, Los Angeles, CA, USA; 2Baylor University Medical Center, Texas Oncology, US Oncology, Dallas, TX, USA; 3Institut Curie, Paris and Saint Cloud, France; 4Institut Jules Bordet – Université Libre de Bruxelles, Brussels, Belgium; 5International Breast Cancer Center (IBCC), Quiron Group, Barcelona, Spain; 6Northwestern University Lurie Comprehensive Cancer Center, Chicago, IL, USA; 7Menarini Group, Florence, Italy; 8Menarini Group, New York, NY, USA; 9Preclinical and Translational Sciences, Menarini Ricerche, Pomezia, Italy; 10University of Texas Health Sciences Center, San Antonio, TX, USA
Background: Elacestrant (ELA) is the first oral selective estrogen receptor degrader (SERD) approved in estrogen receptor–positive/human epidermal growth factor receptor– negative (ER+/HER2–) adv/mBC that targets ESR1- mut tumors. In the EMERALD (NCT03778931) study, patients (pts) who had at least 12 months of prior cyclindependent kinase 4/6 inhibitor (CDK4/6i) duration achieved a median progression-free survival (mPFS) of 8.6 months with ELA versus 1.9 months with SOC, indicating the endocrine sensitivity of this subpopulation (SABCS 2022). In this endocrine-sensitive population, we evaluated the benefit of single-agent ELA in relevant subgroups usually associated with poor prognosis.
Objectives: To evaluate the benefit of single-agent elacestrant in relevant subgroups usually associated with poor prognosis.
Methods: Pts with ER+/HER2– mBC who previously received 1 to 2 lines of endocrine therapy (ET) and prior CDK4/6i were randomized 1:1, ELA or SOC. A subgroup analysis was performed in pts with ESR1-mut by prior duration of ET + CDK4/6i ≥12 months with presence of bone, liver, and/or lung metastases (mets), PIK3CA-mut, TP53-mut, or HER2-low expression, to support clinical treatment decisions.
Results: Overall, 478 pts were randomized to ELA (n=239) or SOC (n=239), 228 pts (48%) had ESR1-mut, and 159 pts (70%) received ≥12 months of prior ET + CDK4/6i. An improvement in PFS favoring ELA vs SOC was consistent across all relevant ESR1-mut subgroups.
ER+/HER2–, ESR1-mut patients with ≥12 months of prior ET + CDK4/6i:
*Includes E545K, H1047R, E542K, among others; **HER2 IHC 1+, and 2+ with no ISH amplification. Data not available for all pts.
Conclusion: ELA was associated with a clinically meaningful improvement in PFS that was consistent across all relevant subgroups in pts with ESR1-mut. These results demonstrate that when ESR1-mut pts remain endocrine sensitive (prior CDK4/6i duration ≥12 months), the ER pathway could be the main driver of disease despite the presence of other resistance mechanisms and regardless of the met site or coexistence of PIK3CA-mut, TP53-mut, or HER2-low expression. Single-agent ELA enables ET sequencing in the second line before other targeted therapies, drug combinations, and chemo-based regimens, including antibody-drug conjugates.
The abstract was previously submitted and presented at both the 2023 San Antonio Breast Cancer Symposium and 2024 Miami Breast Cancer Conference.
Bardia A, Bidard FC, Neven P, et al. EMERALD phase 3 trial of elacestrant versus standard of care endocrine therapy in patients with ER+/HER2– metastatic breast cancer: updated results by duration of prior CDK4/6i in metastatic setting. Cancer Res. 2023;83(5_Suppl). Abstract GS3-01.
Steven Lee-Ramos, MS, RN, AGACNP-BC1; Virginia Seery, MSN, RN, ANP-BC, AOCNP2; Diane Andresen, MSN, APN-C, AOCNP3; Tasha Hall, PhD, RN4; Nicholas Berry, PhD4; Brenda Martone, MSN, ANP-BC, AOCNP5
1Gastrointestinal Medical Oncology Clinic, University of California San Francisco, San Francisco, CA; 2Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; 3John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, NJ; 4Exelixis, Inc., Alameda, CA; 5Robert H. Lurie Cancer Center, Northwestern Medicine, Chicago, IL
Background: Cabozantinib is an oral tyrosine kinase inhibitor approved for the treatment of advanced renal cell carcinoma (RCC), advanced hepatocellular carcinoma (HCC) post-sorafenib, and advanced, radioiodine-refractory differentiated thyroid cancer (RAIR-DTC) that progressed following VEGFR-targeted therapy. Proactive management of cabozantinib-associated adverse events (AEs) may help patients continue treatment, thereby improving outcomes.
Objective: To analyze the frequency and impact of common treatment-emergent adverse events (TEAEs) associated with cabozantinib monotherapy in patients with advanced RCC, advanced HCC, or RAIR-DTC, and to report effective nurse-led strategies to manage these events.
Methods: We analyzed the most common TEAEs leading to dose modifications (dose interruptions or dose reductions) in 3 cabozantinib pivotal trials: METEOR (NCT01865747) for RCC,1 CELESTIAL (NCT01908426) for HCC,2 and COSMIC-311 (NCT03690388) for RAIRDTC.3 For these TEAEs, we summarized the incidence (all grades, grades 3/4), median time to onset of TEAEs, and corresponding rates of cabozantinib dose interruption, dose reduction, and discontinuation. The practicing oncology nurse authors provided their supportive care strategies as well as advice that they provide to patients for the management of these key TEAEs.
Results: In the cabozantinib monotherapy clinical trials, the most frequent any-grade TEAEs resulting in dose modifications were diarrhea (51%-74%), fatigue (42%- 56%), palmar-plantar erythrodysesthesia (PPE; 42%- 46%), and hypertension (30%-39%). Across trials, dose interruptions were required by 5% to 25% and dose reductions by 1% to 22% of patients, while ≤2% discontinued cabozantinib due to any of these TEAEs, supporting the use of proactive management. Oncology nurses are critical throughout the AE management process. Nurses educate patients about common TEAEs and management strategies, the importance of communication regarding TEAEs, time to onset, and the potential for dose modifications. Nurse-led supportive care strategies include dietary changes for diarrhea, exercise and proper nutrition for fatigue, skincare for palmar-plantar erythrodysesthesia syndrome (PPE), and medications (eg, antidiarrheals, antihypertensives, psychostimulants). When AEs are intolerable despite these measures, dose modifications are appropriate. Patients should be made aware that dose modifications help to individualize therapy, improving tolerability so that they can continue treatment.
Conclusion: Cabozantinib improves efficacy outcomes in patients with advanced RCC, HCC, and RAIR-DTC.1-3 Diarrhea, fatigue, PPE, and hypertension were the most frequent TEAEs leading to cabozantinib dose modifications. Oncology nurses are typically the first point of contact for patients experiencing AEs associated with cancer treatments and play an essential role in the management of AEs to maximize clinical benefits for patients. Comprehensive, individualized, and proactive AE management implemented by nurses can improve treatment tolerability and help patients remain on therapy. The effectiveness of proactive management is supported by the low rates of cabozantinib-related discontinuations due to TEAEs observed in pivotal trials.
Heinz-Josef Lenz, MD1; Sara Lonardi, MD2; Elena Elez Fernandez, MD, PhD3; Eric Van Cutsem, MD, PhD4; Lars Henrik Jensen, MD, PhD5; Jaafar Bennouna, MD, PhD6; Guillermo Ariel Mendez, MD7; Michael Schenker, MD8; Christelle de la Fouchardiere, MD9; Maria Luisa Limon Miron, MD10; Takayuki Yoshino, MD, PhD11; Jin Li, MD12; José Luis Manzano Mozo, MD13; Giampaolo Tortora, MD, PhD14; Rocio Garcia-Carbonero, MD15; Rohit Joshi, MD16; Elvis Cela, PhD17; Tian Chen, PhD17; Lixian Jin, MD17; Thierry Andre, MD18
1University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, USA; 2Istituto Oncologico Veneto IOV-IRCCS, Padua, Italy; 3Vall d’Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain; 4University Hospitals Gasthuisberg and University of Leuven (KU Leuven), Leuven, Belgium; 5University Hospital of Southern Denmark, Vejle Hospital, Vejle, Denmark; 6Centre Hospitalier Universitaire de Nantes, Nantes, France; 7Hospital Universitario Fundacion Favaloro, Buenos Aires, Argentina; 8Centrul de Oncologie Sf Nectarie, Craiova, Romania; 9Centre Léon Bérard, Lyon Cedex, France; 10Hospital Universitario Virgen del Rocío, Sevilla, Spain; 11National Cancer Center Hospital East, Chiba, Japan; 12Shanghai East Hospital, Shanghai, China; 13Institut Català d'Oncologia, Badalona, Spain; 14Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy; 15Hospital Universitario 12 de Octubre Imas12, UCM, Madrid, Spain; 16Cancer Research SA, Adelaide, Australia; 17Bristol Myers Squibb, Princeton, NJ, USA; 18Sorbonne Université, and Hôpital Saint Antoine, Assistance Publique Hôpitaux de Paris, Paris, France
Background: Nivolumab plus ipilimumab (NIVO + IPI) demonstrated superior progression-free survival (PFS) versus chemotherapy in patients with previously untreated microsatellite instability-high/mismatch repair–deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC) in the randomized phase 3 CheckMate 8HW study.1 We report expanded efficacy analysis from the prespecified interim analysis of NIVO + IPI versus chemotherapy in the first-line setting.
Objectives: To evaluate the efficacy and safety of NIVO + IPI compared with chemotherapy and NIVO monotherapy for the treatment of MSI-H/dMMR mCRC. This prespecified interim analysis reports results of first-line NIVO + IPI versus chemotherapy.
Methods: Patients with unresectable or mCRC and MSI-H/ dMMR status by local testing were enrolled across different lines of therapy and randomized 2:2:1 to NIVO (240 mg) + IPI (1 mg/kg) Q3W (4 doses, then NIVO 480 mg Q4W), NIVO (240 mg) Q2W (6 doses, then NIVO 480 mg Q4W), or chemotherapy ± targeted therapies; treatments continued until disease progression or unacceptable toxicity (all arms) or for up to 2 years (NIVO ± IPI arms). In patients with blinded independent central review (BICR)-documented progression with chemotherapy, crossover to NIVO + IPI was permitted. Dual primary end points were PFS by BICR per RECIST v1.1 for NIVO + IPI versus chemotherapy (firstline) and NIVO + IPI versus NIVO (all lines) in patients with centrally confirmed MSI-H/dMMR mCRC. PFS2 (time from randomization to progression after subsequent systemic therapy, initiation of second subsequent systemic therapy, or death) was a key exploratory end point.
Results:Among 303 patients randomized to NIVO + IPI (n=202) or chemotherapy (n=101), 171 patients (NIVO + IPI) and 84 patients (chemotherapy) had centrally confirmed MSI-H/dMMR. At 31.5-month median follow-up (range, 6.1-48.4), NIVO + IPI demonstrated superior PFS vesus chemotherapy (median, not reached vs 5.9 months; hazard ratio [HR], 0.21; 97.91% CI, 0.13-0.35, chemotherapy (HR, 0.27; 95% CI, 0.17-0.44), and the 12-month PFS2 rates (95% CI) were 89% (83%-93%) versus 65% (53%-75%), respectively. Among all first-line–treated patients, any-grade and grade 3/4 treatment-related adverse events with NIVO + IPI occurred in 80% and 23% and with chemotherapy in 94% and 48% of patients, respectively. Treatment-related deaths were reported for 2 patients (NIVO + IPI arm).
Conclusion: Clinical benefit with first-line NIVO + IPI versus chemotherapy was maintained after subsequent therapy, as shown by improved PFS2 in patients with centrally confirmed MSI-H/dMMR mCRC. No new safety concerns were identified with NIVO + IPI. These results further support NIVO + IPI as a standard-of-care first-line treatment option for patients with MSI-H/dMMR mCRC.
2024 American Society of Clinical Oncology Annual Meeting; Abstract #3503.
Sarah Smith, BS, CNMT1; Alexander I. Spira, MD, PhD, FACP, FASCO1; Danny Nguyen, MD2; Seema Sethi, DO3; Shirish Gadgeel, MD4
1Virginia Cancer Specialists/US Oncology Research, Fairfax, VA; 2City of Hope, Long Beach, CA; 3Janssen Research & Development, Spring House, PA; 4Henry Ford Cancer Institute, Detroit, MI
Background: Therapy options for advanced non–small cell lung cancer (NSCLC) with common EGFR mutations are limited, while mortality remains high. There is a high unmet need for alternate therapies for advanced NSCLC and common EGFR mutations. The MARIPOSA study investigated the EGFR-MET bispecific antibody amivantamab combined with the third-generation EGFR-TKI lazertinib versus osimertinib.
Objectives: Adverse events (AEs) due to cancer treatments are inevitable and can mar the patient experience, resulting in early treatment discontinuation and poor outcomes; here, we evaluate safety outcomes postprogression in MARIPOSA and discuss key roles nurses play in educating patients on AE risk, proactive AE management, and impact on treatment adherence and outcomes.
Methods: In MARIPOSA, a total of 1074 patients were randomized, and outcomes were reported for the amivantamab- lazertinib efficacy population (n=429) and safety population (n=421), and the osimertinib efficacy population (n=429) and safety population (n=428) arms. Postprogression outcomes included time to discontinuation, time to subsequent therapy, and safety. Nursing implications are based on the authors’ clinical experience in the trial and beyond.
Results:After a median follow-up of 22 months, 35% versus 47% of patients progressed on amivantamab-lazertinib and osimertinib, respectively. Among patients remaining on treatment postprogression (53% vs 51%), those in the amivantamab-lazertinib arm remained longer versus osimertinib (23.6 vs 15.9 weeks). Both time to discontinuation and to subsequent therapy were longer with amivantamab- lazertinib (26.2 months and not estimable, respectively) versus osimertinib (23.0 and 24.1 months). The most common AEs occurred in the first 4 months of treatment, and late onset was uncommon.
Nurses play a crucial role throughout the patient journey via counseling patients and caregivers regarding therapy options, best practices promoting a better treatment experience, risk of progression, and postprogression steps. In addition, nurses can educate patients regarding the likelihood of AEs, such as infusion-related reactions and common dermatological AEs associated with targeted EGFR inhibition (rash and paronychia), and help manage or mitigate these AEs to support patients during the therapy.
Conclusion: Amivantamab-lazertinib treatment demonstrated favorable postprogression outcomes, thus representing a viable first-line treatment option for patients with advanced NSCLC and common EGFR mutations. Incorporating nursing and other healthcare professional perspectives surrounding optimal AE management and patient experience can impact adherence, which is key to ensuring the best chances of survival and benefits from second-line treatment, if progression occurs.
These data were presented at the 2023 North America Conference on Lung Cancer (NACLC) and at the 2024 Oncology Nursing Society (ONS) Conference.
Gerrina Ruiter, MD, PhD1,2; Hai-Yan Tu, MS3; Kiyotaka Yoh, MD4; Yi-Long Wu, MD5; Ute von Wangenheim, PhD6; Maren Rohrbacher, MD, MSc7; Behbood Sadrolhefazi, MD8; John Heymach, MD, PhD9
1Department of Clinical Pharmacology, The Netherlands Cancer Institute, Amsterdam, Netherlands; 2Department of Thoracic Oncology, The Netherlands Cancer Institute, Amsterdam, Netherlands; 3Guangdong Lung Cancer Institute, Guangdong General Hospital, Guangzhou, China; 4Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan; 5Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China; 6Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach an der Riss, Germany; 7Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany; 8Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; 9Department of Thoracic/Head and Neck Medical Oncology, Division of Cancer Medicine, MD Anderson Cancer Center, University of Texas, Houston, TX, USA
Background: Zongertinib is a covalent, wild-type EGFRsparing tyrosine kinase inhibitor that binds selectively to the HER2 tyrosine kinase domain (TKD). In November 2023, zongertinib was granted Fast Track designation by the FDA as an investigational treatment for patients with advanced/metastatic HER2 mutation–positive non–small cell lung cancer (NSCLC) who had progressed on/after platinum-based therapy.
Objectives: Here, we report final data from the Beamion LUNG-1 (NCT04886804) study evaluating the safety and efficacy of zongertinib in HER2 aberration–positive solid tumors (phase Ia) and preplanned futility analysis in HER2 mutation–positive NSCLC (phase Ib).
Methods: Phase Ia enrolled patients with confirmed HER2 aberration–positive (gene mutations, rearrangements, amplification, or overexpression) advanced/unresectable/ metastatic solid tumors, refractory to/unsuitable for standard treatment. Patients received escalating doses of zongertinib orally twice daily (BID; ≥15 mg) or once daily (QD; ≥60 mg), guided by a Bayesian model with overdose control. The primary end point of phase Ia was maximum tolerated dose based on dose-limiting toxicities. Phase Ib is recruiting patients with HER2 mutation–positive advanced/metastatic NSCLC into 5 cohorts: (1) previously treated HER2 TKD mutation positive; (2) treatment- naive HER2 TKD mutation positive; (3) previously treated non-TKD HER2 mutation positive; (4) active brain metastases; and (5) prior treatment with an anti-HER2 antibody–drug conjugate). In cohort 1, patients were initially randomized to receive 120/240 mg zongertinib QD; the 120 mg QD dose was selected at interim analysis. Cohort 1 primary end point is overall response rate (ORR; RECIST version 1.1) by central independent review.
Results: As of January 29, 2024, 83 patients in phase Ia received zongertinib at 15/30/60/100/150 mg BID (n=3/3/4/4/3) and 60/120/180/240/300/360 mg QD (n=5/5/13/17/20/6). Median treatment duration: 4.2 months were reported in 76%/8%/1%/0% of patients. Two patients had serious treatment-related adverse events. In all evaluable patients (n=74) and patients with NSCLC (n=41), confirmed ORRs/disease control rates (DCRs) were 35%/85% and 44%/93%, respectively. Median duration of response was 12.7 months (95% CI, 5.6-15.8) and 15.8 months (5.6-15.8), respectively. In zongertinib QD group, median progression-free survival was 8.3 months (95% CI, 5.6-13.9) overall and 12.3 months (7.6- 17.2) for NSCLC. In the prespecified phase Ib futility analysis (July 31, 2023), 42 patients were treated (cohort 1); ORR/DCR rates were 74%/91% (n=23).
Conclusion: Zongertinib was well tolerated and demonstrated promising efficacy in patients with HER2-driven solid tumors, including HER2 mutation–positive NSCLC.
This abstract was submitted for presentation at the World Conference on Lung Cancer Congress, held September 7-10, 2024, in San Diego, CA, USA.
Keep up to date with the latest news from us via social networks:
To sign up for our print publication or e-newsletter, please enter your contact information below.
