501 Background: EC remains a global health challenge with a rising incidence and poor prognosis despite advancements in treatment modalities. Standard therapies include surgery, chemotherapy (CT), radiation therapy, and recently, targeted and immunotherapy. The PD-L1 inhibitors pembrolizumab (pembro) and nivolumab (nivo) received FDA approval for frontline treatment in EC in March and May 2021, respectively, based in part on the KEYNOTE-590 (KN590) and CheckMate 648 trials. In this study, we aimed to uncover rationale in physician preference for PD-L1 inhibitors in EC. Methods: US-based oncologists convened at two in-person meetings in April 2024 to discuss clinical and real-world data presented at the 2024 ASCO GI Cancers Symposium. Among data discussed included the KN590 5-year update. Survey questions were fielded at the meeting to capture participants’ impressions. Demographics were captured via an online survey ahead of the meeting. Responses from participants who manage EC and responded to all survey questions were aggregated. Results: 86 participants qualified; and, collectively, are 76% community physicians with 18 years average in clinical practice, see 18 patients median on clinic days, and spend 83% of their time in direct patient care on average. ECOG PS status (50%), tumor histology (52%), and location/stage (48%) were reported as critical factors in treatment decision-making; only 14% said PD-L1 status was a major factor. Participants were queried on a hypothetical patient case of esophageal squamous cell and adenocarcinoma before and after reviewing the KN590 data. Prior to reviewing KN590, physician preferences in the squamous cell 1L setting were split between nivo+CT and pembro+CT; following data review, pembro+CT was favored nearly 3:1. In the adenocarcinoma 1L setting, preference shifted from 60/40 nivo+CT to 60/40 pembro+CT, see Table. The cohort were most impressed with the overall survival (87%) and objective response rates (40%), and 55% would consider pembro+CT for both squamous cell and adenocarcinoma disease while 37% would consider it for PD-L1 CPS>10 squamous cell disease only. Conclusions: Our study showed PD-L1 status was not a major factor in clinical decisions. The shift in treatment preference toward pembro+CT for both patient cases following KN590 data review suggests an impact for data review to influence physician behavior. This highlights the importance of educational initiatives to disseminate clinical updates to providers. It is still to be determined the optimal platform and length for these initiatives, and to quantify their effectiveness. 65-year-old male patient with advanced EC;PD-L1 CPS ≥10;ECOG PS of 1 Squamous cell disease Adenocarcinoma Before After Before After Fluoropyrimidine (FP) + platinum (P)-based CT 1% 1% 1% 0% FP +P-based CT + nivo 55% 27% 60% 36% FP + P-based CT + pembro 43% 71% 38% 63% Nivo + ipilimumab 1% 1% 0% 1% None of the above 0% 0% 0% 0%

171 Background: Serious mental illness (SMI), defined as a mental, behavioral, or emotional disorder resulting in serious functional impairment, that substantially interferes with or limits one or more major life activities, includes schizophrenia, bipolar disorder, and major depression. Patients with SMI and cancer have poor survival rates attributed to inequities in cancer care. Such patients are often diagnosed at an advanced stage and are more likely to have their cancer care interrupted. This study surveyed the general practices oncologists apply to integrate mental health and cancer care in their clinical practice. The study also surveyed perspectives on personalized collaborative care intervention to improve cancer outcomes in patients with SMI while identifying the barriers to adapting such intervention in clinical settings. Methods: In February and March 2024, US-based hematologists/oncologists convened at live meetings to discuss abstracts presented at the 2023 ASCO Quality Care Symposium. An online premeeting survey was used to collect participants’ demographics. Participants’ approach to mental health care for patients with cancer were captured via an audience response system during the live meetings. Responses were aggregated and analyzed using descriptive statistics. Results: Among 125 participants, 77% were community providers. The majority of participants (60%) reported frequently discussing mental health with their patients with cancer. Respondents support the mental health needs of their patients with cancer by utilizing in-house social workers (52%) or in-house counseling services (31%), or by referring to in-house clinical psychologist (40%) or an external psychiatrist (41%). They identified challenges to integrating mental health care into cancer treatment: lack of dedicated staff (54%), high patient volume (44%), and lack of available psychosocial tools (40%). Additionally, a subset of participants was asked about their perspectives on collaborative care intervention for cancer care of patients with SMI, and while most participants were encouraged, they also reported that mental health services should be coordinated primarily through either a psychiatrist (25%) or a social worker (25%). Interestingly, limited access to psychiatric care (78%) and lack of resources to screen patients for SMI (56%) were the primary barriers to adapting a personalized and collaborative care approach in the real-world setting. Conclusions: Participants were inclined to incorporate personalized mental health assessments into routine clinical care for their patients with cancer, however they face several barriers to implementation. Further research is needed to address those modifiable barriers and assess the impact of a personalized and collaborative care approach on timely diagnosis and mitigating inequities in cancer care to improve cancer outcomes in patients with SMI.

AbstractIntroductionInitially approved for the fifth‐line or later therapeutic setting, the chimeric antigen receptor (CAR) T‐cell regimen ciltacabtagene autoleucel (cilta‐cel) was recently approved for second‐line (2L) treatment in relapsed/refractory multiple myeloma (RRMM). Oncology practitioners use clinical trials to inform treatment, but real‐world impressions and impact on practice are lacking. We aimed to determine whether presenting CARTITUDE‐4 clinical trial data would impact real‐world preferences/perceptions around CAR T‐cell therapy.MethodsRecruiting from the Cardinal Health Oncology Provider Extended Network (OPEN), we surveyed hematologists/oncologists to investigate fourth‐line (4L) preferences in a hypothetical patient with triple‐class–refractory MM. We posed the same questions and answers before and after the trial presentation and compared pre‐/post‐preferences toward cilta‐cel and sequencing relative to bispecific antibodies (BsAbs). Using the same methodology as described above, we also performed a secondary analysis comparing pre‐/post‐perceptions on the use of CAR T‐cell therapy in earlier lines for patients with triple‐class–refractory MM.ResultsAmong 50 respondents, decision‐making factors before the trial presentation included CAR T‐cell center availability (58%), comorbidities (52%), and center locations (34%). Additionally, 48% of 46 respondents chose 4L cilta‐cel. Among 47, 40% wanted more real‐world/long‐term CAR T‐cell therapy outcomes in any line, 38% wanted more 2L data, and 34% favored 2L/third‐line (3L) use. After the presentation, the preference for cilta‐cel doubled from 48% to 88% (p < 0.001) among 50 respondents and rose from 34% to 55% (p = 0.001) for earlier‐line CAR T‐cell therapy among 49. Moreover, 55% of 49 respondents preferred CAR T‐cell therapy prior to BsAbs.DiscussionWe have shown that making oncology practitioners aware of trials precipitated decision‐making factors and led to notable, significant shifts in future intended practice patterns. Being aware of trial data enables practitioners to make more informed decisions, tailor therapies to individual patients, and ultimately improve outcomes.

Context Utilization of anti-CD38 mAbs within quadruplet therapies for the management of TE NDMM is currently considered optimal standard of care. However, little is known about which of the available anti-CD38 mAbs, daratumumab or isatuximab, is preferred and the rationale behind the selection. Objective Evaluate trends in self-reported treatment patterns and perceptions surrounding clinical care of TE NDMM. Design U.S.-licensed oncologists/hematologists convened at one of 3 live meetings from February to April 2024 to review clinical updates presented at the 2023 ASH Annual Meeting. Respondent characteristics and demographics were collected via an online survey ahead of the meeting. During the meeting, participants responded to queries about their treatment preferences in NDMM before and after reviewing the efficacy/safety data from the phase 3 PERSEUS and IsKia trials (PERSEUS: bortezomib, lenalidomide, and dexamethasone [VRd] ± daratumumab; IsKia: carfilzomib, lenalidomide, and dexamethasone [KRd] ± isatuximab). Responses were captured via audience response system technology; not all participants answered every question. Pooled data were summarized using descriptive statistics. Results The 164 respondents saw an average of 18 patients/day and averaged 17.3 years of experience; 71.1% identified as community providers. The preferred anti-CD38 mAb reported by respondents was daratumumab (94.2%). Respondents reported efficacy (49.1%) and administration route (intravenous versus subcutaneous; 30.7%) as the top factors that influence their choice of anti-CD38 therapy. Prior to reviewing the PERSEUS and IsKia data, advisors reported that they prefer Dara-VRd as first-line treatment for TE NDMM that is standard-risk (61.6%) or high-risk (80.1%). After reviewing the PERSEUS and IsKia data, Dara-VRd preference was 83.2% (+21.6 percentage points) for standard-risk and 73.3% (−6.8 percentage points) for high-risk TE NDMM. The top factors identified that influenced the respondents’ preference for VRd as the backbone therapy (90.8%) were toxicity profile (57.4%), efficacy (52.9%), and patient comorbidities (36.1%). Conclusion Overall, daratumumab was the preferred anti-CD38 mAb among our respondents in frontline treatment of TE NDMM. Respondents reported that the rationale for their selection of daratumumab over isatuximab included efficacy, administration route, safety profile, and disease characteristics. Future research should focus on what clinical and nonclinical factors affect this decision.

Abstract Background: Fertility preservation and family planning are pressing survivorship concerns for many young, reproductive-aged women with hormone receptor-positive (HR+) early-stage breast cancer. Following primary treatment, patients typically receive 5-10 years of adjuvant endocrine therapy (ET), during which pregnancy is contraindicated and fertility may decrease. The first-of-its-kind POSITIVE trial (NCT02308085) sought to challenge this archetype by prospectively evaluating the impact of temporary ET interruption to allow patients to attempt conception. Participants (n=516) received 18-30 months of ET followed by a 3-month washout period prior to initiating a 2-year break from therapy to attempt pregnancy. Results demonstrated that short-term disease outcomes were not impacted by temporarily pausing therapy to allow women who desire conception to attempt pregnancy. This survey-based study aimed to evaluate community oncologists’ perceptions of the POSITIVE trial data, ET interruption, and fertility preservation efforts. Methods: US-based oncologists convened at three live meetings in March and April 2023 to review clinical updates presented at SABCS 2022. Participant characteristics and demographic data were collected via an online survey prior to the respective meetings. Perceptions/reactions to clinical updates were captured using audience response system technology. Data were summarized using descriptive statistics. Results: Among 157 respondents, 82.8% identified as community providers, with 17.9 mean years of clinical experience. On average, participants reported that 85.4% of their time is allocated towards direct patient care, with approximately 21 patients seen per clinic day. Most respondents (85.8%) indicated that they only refer patients to a fertility specialist if the patient initiates fertility preservation discussions and nearly half (45.7%) reported that within the last year, 20% or less of their patients have discussed fertility concerns with them prior to initiating therapy. Additionally, over three-quarters of respondents (79.9%) indicated that 10% or less of their patients with breast cancer underwent fertility preservation within the last year. Prior to reviewing the POSITIVE trial data, 51.3% of respondents reported that they would be most likely to offer therapy interruption to patients with low- or intermediate-risk disease, while 19.8% would do so for all patients regardless of risk status. After reviewing the POSITIVE trial data, 59.3% of respondents would offer therapy interruption to patients with low- or intermediate-risk disease, while 30% would do so for all patients regardless of risk status. Notably, a majority of respondents (54.8%) indicated that they would recommend a therapy interruption of 12 months or less, while 11.1% would opt for 19-24 months. Conclusions: Findings demonstrate that the onus of initiating discussions surrounding fertility and reproductive topics is often placed on patients, and many patients do not proactively address these matters or undergo fertility preservation prior to initiating treatment. Overall, respondents viewed the POSITIVE trial favorably, as evidenced by their increased willingness to consider temporary ET interruption for all patients following their review of the study data. Although the POSITIVE trial allowed up to 2 years of therapy interruption, respondents preferred a treatment break of 12 months or less. With the adoption of the POSITIVE strategy into routine clinical practice, younger women with HR+ breast cancer may no longer be faced with the difficult choice of pursuing potentially life-saving therapy or starting/expanding a family, thereby addressing a current unmet survivorship need among this patient population. However, it remains to be seen how many physicians will offer this approach, who is the ideal candidate, and what the appropriate ET interruption length will be. Citation Format: Brooke Leon, Robert Bone, Yolaine Jeune-Smith, Sigrun Hallmeyer, Bruce Feinberg. Provider perceptions of the POSITIVE trial, endocrine therapy interruption, and fertility preservation [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO4-11-11.

e20007 Background: Epidermal Growth Factor Receptor mutations ( EGFRm) are commonly found in patients with resectable and metastatic non-small cell lung cancer (NSCLC). In December 2020, the FDA approved adjuvant osimertinib, for resectable EGFRm NSCLC, based on results of the ADAURA trial which showed significant survival benefit compared to placebo post-resection, further reinforcing need for biomarker testing in NSCLC. In light of publication of Aduara this study aims to understand US oncologists' biomarker testing practices and adjuvant osimertinib use in resectable EGFRm Stage IB–IIIA NSCLC. Methods: Questions related to biomarker testing and adjuvant therapy decision-making for resectable EGFRm Stage IB–IIIA NSCLC were presented to US-based oncologists/hematologists during live meetings in June and July 2023. In addition, questions related to impact of updated overall survival data from ADAURA trial on physicians’ reported treatment preferences were presented.Up to 108 participants responded to questions, though not all participants answered each question. Aggregate responses were summarized using descriptive statistics. Results: Among respondents, 52% identified as medical oncologists and 46% as hematological oncologists, 41% identified as being from an independent community practice and 75% indicated lung cancer was among the 3 solid tumors they most often treat. For patients with newly diagnosed resectable NSCLC patients, respondents indicated that genetic testing was performed before surgery on initial diagnostic biopsy sample (73%), after surgery (44%), and upon progression/relapse (31%). Commonly utilized diagnostic tools reported by respondents included NGS testing of tissue samples (87%), NGS liquid biopsy (42%), and IHC (31%). Barriers impacting molecular testing practices for resectable NSCLC included access to tissue for testing, cost to patient, disease stage, histology, tumor burden, patient age, patient fitness, and prior authorization or time to approval. Half (50%) of respondents reported prescribing adjuvant osimertinib monotherapy for patients with resectable EGFRm NSCLC in the past 6 months. After reviewing the updated ADAURA data, most (83%) respondents indicated they would prescribe adjuvant osimertinib immediately following surgery for resectable EGFRm NSCLC, and 56% would prescribe adjuvant osimertinib with or without adjuvant chemotherapy, 21% would prescribe adjuvant osimertinib with adjuvant chemotherapy, and 17% would prescribe adjuvant osimertinib only. Conclusions: Overall, nearly three-fourths of medical oncologist respondents prefer pre-operative genetic testing and regardless of test timing, when EGFRm identified > 80% will treat adjuvantly with osimertinib. Unfortunately, multiple barriers complicate this pursuit of evidence-based medicine.

Background: Human epidermal growth factor receptor 2 (HER2)-targeted therapies are an established treatment for patients with HER2-positive breast cancer, however, these therapies have not proven effective in the HER2-negative setting. Until recently, HER2 status was used to guide treatment decisions based on a binary classification of positive or negative. A new pathological category, HER2-low, has emerged as a subtype of interest within the breast cancer treatment landscape. HER2-low status is defined as a HER2 immunohistochemistry score of 1+ or 2+ and a negative in-situ hybridization result. DESTINY-Breast04 (DB04) was the first trial to evaluate a HER2-targeted agent within the metastatic HER2-low breast cancer setting. The anti-HER2 agent trastuzumab deruxtecan (T-DXd) demonstrated promising clinical activity in HER2-low expressing tumors. However, development of T-DXd-related interstitial lung disease (ILD) remains a concern when using this therapy. This survey-based study aimed to evaluate community oncologists’ perceptions of the DB04 data, HER2-low directed treatment, and management of ILD. Methods: U.S.-based oncologists (n=83) convened at two live meetings in June 2022 to review clinical updates presented at ASCO 2022. Participant characteristics and demographic data were collected via an online survey prior to the respective meetings. Perceptions/reactions to clinical updates were captured in real-time via electronic keypad. Data were summarized using descriptive statistics. Results: Among respondents, 83.1% identified as community providers, with an average experience of 20.7 years in practice. On average, participants reported that 88.2% of their time is allocated towards direct patient care, with roughly 18 patients seen per clinic day. Nearly half of respondents (49.4%) reported awareness of HER2-low as a distinct pathological category prior to the presentation of DB04 at ASCO 2022, however, less than 10% of respondents had previously used this sub-category to determine therapy. Increased T-DXd-related ILD, which occurred in 12% of trial participants, was cited as the greatest limitation of the DB04 trial by over one-third (37.3%) of respondents. After reviewing real-world evidence data of ILD incidence in metastatic breast cancer, nearly one-third (31%) of respondents reported that their observed ILD rates are less than DB04, but more (36%) said that ILD can be hard to quantify because patients are not always symptomatic. When asked if the ILD rate associated with T-DXd would limit their selection of this agent for their patients with breast cancer, approximately one-quarter (24.1%) of respondents indicated that they would reserve T-DXd use for patients without symptomatic pulmonary disease. However, the majority of respondents (60.2%) indicated that they would not limit their use of T-DXd based on ILD rates, with most (55.4%) opting for a risk-management approach involving increased monitoring for the development of ILD-related adverse events. Conclusions: Advancements in assay interpretation have made it possible to differentiate gradients of HER2 expression, creating a space for pathological sub-categories within a formerly binary paradigm. Among providers who reported awareness of HER2-low as a distinct pathological sub-category, few had used this as a benchmark to guide their treatment decisions prior to the presentation of DB04 at ASCO 2022. Newer anti-HER2 agents, such as T-DXd, provide a potential new standard of care for patients with HER2-low expressing tumors. Despite the concern of ILD rates associated with T-DXd use, the majority of providers do not view this as a limiting factor due to the ability to closely monitor patients for the development of adverse events coupled with appropriate provider/patient education. Citation Format: Brooke Leon, Robert Bone, Yolaine Jeune-Smith, Bruce Feinberg. Provider perceptions of DESTINY-Breast04, HER2-low directed treatment, and interstitial lung disease [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P1-11-05.

342 Background: Patient-reported outcomes (PROs) assess a patient’s self-reported health status, including disease symptoms, treatment experience, functional outcomes, and quality of life. Incorporation of PROs has been linked to improved patient symptom control and increased shared decision making. Standardized PRO measures (PROMs) are becoming more frequent as an endpoint for clinical trials, however their use is less frequent in routine care for patients with cancer. The goal of this study was to assess the utilization of PROMs and identify barriers to their use. Methods: US-licensed oncologists/hematologists convened at one of three live meetings in 2023 to review recent clinical updates. Respondent demographics were collected ahead via an online survey. During the meetings, participants responded to queries on their use and perceptions of PROs and PROMs. Responses were captured via audience response system technology; not all participants answered every question. Pooled data were summarized using descriptive statistics. Results: Of the 146 respondents, 77.4% self-identified as community-setting providers, spent 84.3% of their time seeing patients, saw an average of 19.8 patients/day, and averaged 17.7 years of experience. Respondents found PROs to be most useful in early detection/management of treatment toxicities and symptoms (63.8%) and tailoring of clinical/supportive care (56%). The majority of PROs are typically recorded through informal verbal inquiries, while 18.1% and 10.9% of respondents use validated and non-validated PROMs, respectively. Few respondents (11.3%) administer PROMs to every patient at every visit, while over one-third (38.3%) never administer PROMs. Within the practice, medical assistants and nurses are most likely to be the provider administering PROMs. PROMs are most commonly administered when the patient is in the office and are infrequently administered through other means. Lack of time to administer or review PRO surveys (45.1%), and lack of reimbursement (38.9%) and EMR integration (38.9%) were the most common reported barriers to using PROMs in the respondents’ practices. Conclusions: Despite the majority of respondents finding PROs useful in practice, a minority use formal measures to record PROs. Further, usage is infrequent across patient visits. Lack of time, lack of reimbursement, and logistic barriers are the most common reasons for not using PROMs in routine care. These barriers may be overcome by efforts or guideline changes from regulatory agencies, payors, or clinical guideline organizations. Future work will assess how physicians are using PROMs in treatment selection for their patients with cancer.

546 Background: Studies suggest that PARPi agents work best in cancers, including metastatic castration-resistant prostate cancer (mCRPC), that have mutations in DNA repair pathways regulated by homologous recombination repair ( HRR) genes . The first PARPis for prostate cancer (olaparib for HRR-mutated and rucaparib for BRCA-mutated CRPC) were approved in 2020. Two recent trials, TALAPRO-2 and PROpel, evaluate PARPis plus an androgen receptor pathway inhibitor for patients both with and without genetic mutations were presented at ASCO GU 2023. This study aimed to determine oncologists’ perceptions of these new data. Methods: In April 2023, US-based oncologists were invited to attend one of two meetings to discuss data from ASCO GU 2023. Demographics were collected in an online survey, and perceptions of the TALAPRO-2 and PROpel trials were captured via audience response system technology at the meetings. Results: Across the two meetings, 115 oncologists were surveyed; 99 oncologists (86%) indicated that they manage patients with prostate cancer. Of these, 74% reported that they either very often or always test for HRR mutations, and the majority are testing at initial diagnosis of metastatic disease. Prior to reviewing trial updates, 84% of oncologists reported olaparib as their preferred PARPi, and the top factors driving their preferences are efficacy (83%) and safety/tolerability (63%). Perceptions of the trial updates are reported in Table 1. A subset of oncologists were also asked their treatment preferences for patients with mCRPC before and after the trial updates. Altogether, there was a 41% increase in physicians who would use talazoparib plus enzalutamide in an ATM-mutated patient after progression on docetaxel. They were also more likely to report (35%) a preference for this combination for a BRCA1-mutated patient after progression on abiraterone acetate. Additionally, there was a 27% increase in physicians who would use olaparib plus abiraterone acetate in an HRR-wild type patient after enzalutamide. Conclusions: Overall, these data show that clinical updates regarding PARPi agents have an impact on practicing oncologists. However, further exploration of genetic testing practices among oncologists and the impact of emerging data on real-world practice is needed.[Table: see text]

Background: Following the completion of induction therapy for newly diagnosed multiple myeloma (NDMM) patients who are transplant-eligible, autologous stem cell transplantation (ASCT) consolidation with high-dose melphalan followed by lenalidomide maintenance therapy is considered standard of care. However, accumulated evidence of significant benefit and deep responses to newer induction therapies that contain combinations of immunomodulatory drugs and proteasome inhibitors have raised questions about the role as well as timing (upfront vs delayed) of ASCT consolidation in the initial treatment of ASCT-eligible NDMM. DETERMINATION is a phase III clinical trial (NCT01208662) that randomly assigned transplant-eligible NDMM patient to treatment with lenalidomide, bortezomib, and dexamethasone with and without an ASCT consolidation, followed by lenalidomide maintenance until progression. The present study surveyed oncologists and hematologists to evaluate their perceptions of the DETERMINATION trial and the benefits and barriers of integrating ASCT into 1L therapy for transplant-eligible NDMM. Methods: In July 2022, U.S.-based oncologists were invited to attend a live meeting to discuss abstracts presented at ASCO 2022. Demographics data were collected in a premeeting survey. The perceptions and reactions of these providers to abstract data, including an abstract detailing the findings from the DETERMINATION trial, were captured via audience response system (ARS) technology. Not all participants answered every question. Responses were aggregated and analyzed using descriptive statistics. Results: Among the 52 participants who attended the live meeting, 79% (n=41) identified as community providers; these providers reported that they see an average of 20 patients on clinic days. Ninety percent (n=45) of the participants who were responders to the DETERMINATION trial data (n=50) indicated that they treat NDMM. After reviewing the trial data, slightly less than half of providers (42%) reported that the data were compelling enough to increase the use of ASCT in the 1L for patients with transplant-eligible NDMM. Of those respondents who treat NDMM, three-quarters were likely to give lenalidomide maintenance therapy until disease progression as opposed to a fixed duration of maintenance therapy. We also found that a lack of overall survival (OS) benefit was a major drawback in DETERMINATION results for most respondents; specifically, when queried on the top limitation of the trial, 73% of respondents (n=33) chose lack of significant OS data. Finally, when making decisions on triplet regimens in multiple myeloma, OS and progression-free survival (PFS) benefits were reported as treatment decision drivers by 44% and 23% of respondents who treat NDMM, respectively. Conclusions: Overall, our data show that OS (which was not a primary endpoint in DETERMINATION) is viewed as the most significant factor when considering 1L treatment decisions in NDMM, and less than half respondents indicated that PFS (a primary endpoint in DETERMINATION) persuaded them to increase their use of upfront, vs delayed, ASCT in their patients with transplant-eligible NDMM. Future research by the Cardinal Health Specialty Solutions will aim to clarify various aspect of novel therapies for NDMM including quadruplet 1L therapy, other anti-CD38 antibody upfront usage, minimal residual disease, and their respective impacts on the choice of upfront (vs delayed) ASCT consolidation in the 1L setting.

Background: According to the National Cancer Care Network guidelines, chemoimmunotherapy with bendamustine + rituximab (BR) is considered standard first-line (1L) therapy for mantle cell lymphoma (MCL), followed by autologous hematopoietic cell transplant (ASCT) consolidation. Most MCL patients who are refractory to BR therapy and/or ineligible for ASCT will relapse. Ibrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, recently received accelerated approval as a second line (2L) chemotherapy for MCL to help prevent relapse in ASCT- ineligible patients. Expanding upon the success of the ibrutinib' approval in the 2L, the SHINE trial (NCT01776840) sought to determine the efficacy of ibrutinib in combination with BR in the 1L setting as a therapy for older, ASCT-ineligible patients with stage II-IV MCL. At the American Society of Clinical Oncology (ASCO) 2022 annual conference, it was reported that the SHINE trial had satisfied the primary endpoint of improved progression-free survival. We surveyed providers' perceptions of the SHINE trial and the likelihood that they would adopt ibrutinib + BR (IBR) therapy in the 1L setting. Methods: At two live events held in June and July of 2022, U.S.-based oncologists who treat MCL (n=89) were invited to hear discussions on select abstracts presented at ASCO 2022, including an abstract on the SHINE trial. The demographic profile of our participant population was collected via a pre-event survey. Participants' perceptions and reactions regarding the SHINE trial were collected in real-time using an electronic keypad. Not all participants who attended answered every survey question. Descriptive statistics were used to assess participants' perceptions and reactions. Results: Within a typical 3-month period, 35 (39%) participants reported that they are referred < 1 new patient with MCL, while 34 (37%) participants reported that they are referred ≥ 1 new patient with MCL. Seventy-three (82%) participants self-identified as community providers. Participants possessed an average of 22 years of clinical experience. During clinical hours, the median amount of time participants reported they focus on direct patient care was 90% (20%-100%). Sixty-three (71%) of participants stated that they prefer standard BR therapy as a 1L therapy for patients diagnosed with MCL. Sixty-four (72%) of the participants reported atrial fibrillation, and 54 (61%) reported bleeding 54 (61%) as the most concerning issues when considering IBR therapy. Sixty-nine (78%) participants agreed that if FDA approved, IBR would be likely adopted as their primary, 1L MCL regimen. Conclusions: Overall, our participants' perceptions of the SHINE trial data were positive. Following the presentation of the SHINE trial and data for the IBR regimen in MCL, participants were most concerned with the atrial fibrillation and bleeding adverse events, respectively. Despite these safety concerns, nearly 4 in 5 (78%) participants consider it likely that they would prescribe the IBR regimen based on the SHINE study results and assuming FDA approval, as a 1L therapy for patients diagnosed with MCL. Second generation BTK inhibitors have demonstrably improved safety and efficacy profiles, and many of our participants expressed a desire to see further studies of second generation BTK inhibitors added to the BR therapy backbone as a potential future regimen of interest.