INTRODUCTION
Despite recent advances in treating multiple myeloma (MM) with proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), monoclonal antibodies (mAbs), and B‐cell maturation antigen–targeted therapies, MM remains incurable. 1 , 2 Patients with newly diagnosed MM have a poor health‐related quality of life (HRQOL) from the disease itself, and HRQOL tends to significantly worsen in patients with relapsed/refractory MM (RRMM). 3 In addition, the treatment for MM contributes to the adverse HRQOL because of demanding treatment administration and monitoring schedules, along with adverse events (AEs). 4 , 5 , 6 , 7 Patients refractory to multiple lines of therapy experience further deterioration in HRQOL with each additional line of therapy 8 ; thus, the goal of treatment in patients with RRMM is to induce remission without negatively affecting HRQOL. 9 Patient‐reported outcomes (PROs) are important for assessing and better characterizing the profile of novel treatments and complementing clinical efficacy and safety outcomes.
Talquetamab is the first approved bispecific antibody that targets G protein–coupled receptor family C group 5 member D (GPRC5D), a novel receptor highly expressed in malignant versus normal plasma cells, for the treatment of RRMM. 10 , 11 In the single‐arm, phase 1/2 MonumenTAL‐1 study, talquetamab showed deep and durable responses with a clinically manageable safety profile in patients with RRMM who were triple‐class exposed (including a PI, IMiD, and anti‐CD38 mAb). 12 At a median follow‐up of 29.8 and 23.4 months for patients receiving talquetamab at the approved doses of 0.4 mg/kg weekly (QW) and 0.8 mg/kg every other week (Q2W), respectively, overall response rates (ORRs) were 74.1% and 69.5% and median time to first response was 1.2 and 1.3 months, respectively. 13 Median progression‐free survival was 7.5 and 11.2 months, respectively. The most common AE was cytokine release syndrome (CRS; 73%–79% across cohorts), with most events occurring during step‐up doses. 13 On‐target, off‐tumor events, also referred to as GPRC5D‐related AEs, were common and included taste‐related changes (dysgeusia, hypogeusia, ageusia, and taste disorder), nonrash and rash skin‐related events, and nail‐related events; these AEs were mostly grade 1/2 (per Common Terminology Criteria for Adverse Events; dysgeusia has a maximum grade of 2), and led to few treatment discontinuations ( n = 6; three due to skin‐related events and three due to taste‐related events) during the follow‐up period. 13
Previous publications have presented PRO results in early cycles for patients receiving talquetamab, which reflect patient experience during treatment initiation. 14 , 15 Here, we report PRO results for patients receiving talquetamab 0.8 mg/kg Q2W from MonumenTAL‐1, which focus on results in later cycles, in order to assess patient experience over the course of treatment.
MATERIALS AND METHODS
Study design and patients
The study design and methods of the MonumenTAL‐1 study have been previously published. 12 , 13 , 16 Briefly, MonumenTAL‐1 is an open‐label, multicenter, phase 1 ( ClinicalTrials.gov identifier NCT03399799 ) and phase 2 ( ClinicalTrials.gov identifier NCT04634552 ) study in patients with RRMM. The phase 1 portion of the study identified the recommended phase 2 doses of talquetamab (0.4 mg/kg QW or 0.8 mg/kg Q2W, preceded by two or three step‐up doses, in 28‐day cycles). The phase 2 portion of the study enrolled patients who were aged ≥18 years; had measurable myeloma per International Myeloma Working Group (IMWG) criteria 17 ; had documented progressive disease on the basis of IMWG 2016 criteria 18 or within 12 months of the last line of therapy; had received ≥3 prior lines of therapy including an IMiD, PI, and anti‐CD38 antibody; and had an Eastern Cooperative Oncology Group performance status of 0–2. 12 , 13 , 16 Prior exposure to antibody–drug conjugates was permitted; prior T cell–redirecting therapy was not allowed, except in a separate phase 2 cohort that enrolled patients who had prior exposure to these therapies (including bispecific antibodies and chimeric antigen receptor T‐cell therapy). Patients in the prior T‐cell redirection cohort were not included in the current PRO analysis.
The primary end point in MonumenTAL‐1 was ORR. 12 , 13 , 16 Secondary end points included duration of response, rate of very good partial response or better, rate of complete response or better, time to response, progression‐free survival, and incidence of AEs. 12 , 13 , 16 Change from baseline in patient‐reported symptoms, functioning, and HRQOL were secondary end points of the phase 2 part of the study. Data presented in this article reflect a data cutoff date of January 29, 2024.
This study was conducted in accordance with the principles of the Declaration of Helsinki and Good Clinical Practice guidelines of the International Council for Harmonisation. Study protocol and amendments were approved by each site’s institutional review board. All patients provided written informed consent.
PRO measures
PROs were assessed at screening (referred to as “baseline” and assessed before step‐up doses), day 1 of cycle 1 (first full dose), and day 1 of every other cycle. PRO instruments included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ‐C30), EuroQol 5‐Dimension 5‐Level (EQ‐5D‐5L) questionnaire, and Patient Global Impression of Severity (PGIS) instrument. Results in the main text are reported for cycle 21, which has adequate sample sizes across PRO assessments; although the figures show data through cycle 27, caution should be used when interpreting results in later cycles with small sample sizes.
The EORTC QLQ‐C30 is a cancer‐specific questionnaire with a 1‐week recall period that consists of 30 items across one global health status (GHS) scale, five functional scales (physical, emotional, role, social, and cognitive), and several single items (fatigue, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and nausea and vomiting). 19 All scale and item scores were linearly transformed to a 0‐to‐100 scale according to the algorithm in the EORTC QLQ‐C30 Scoring Manual, version 3.0. 20 For GHS and functional scales, higher scores represent a better GHS and level of functioning. Conversely, for symptom‐oriented scales, higher scores correspond to worse symptom severity. The reliability, validity, and clinically meaningful change threshold (≥10 points) for the EORTC QLQ‐C30 have been demonstrated in patients with MM. 21 , 22 , 23
The EQ‐5D‐5L assesses generic health status on five dimensions (mobility, self‐care, usual activities, pain/discomfort, and anxiety/depression) and includes a visual analog scale (VAS) wherein respondents rate their overall health on a scale of 0 to 100, with scores ranging from 0 (worst imaginable health state) to 100 (best imaginable health state). 24
The PGIS instrument is a single item that assesses the overall impression of severity of MM symptoms at a given time, and respondents rate their disease severity from “none” to “very severe.”
Statistical analysis
Compliance rates for PRO assessments, descriptive mean values at each time point, and time‐to‐event analyses of PRO assessments were calculated for all treated patients with PRO assessments. Analyses of change in PRO assessments and regression models for PROs included all patients with a baseline PRO assessment and who had received one postbaseline assessment.
Descriptive statistics were used for PRO assessments: number and percentage were used to report categorical variables, with means, medians, and ranges used to report continuous variables. There was no imputation of missing data. No adjustments for multiplicity were made, and no p values are presented. Compliance rates for completion of PROs were calculated as the number of assessments received divided by the number of assessments expected (number of patients on treatment) at each time point. Changes from baseline in the EORTC QLQ‐C30 scales and EQ‐5D‐5L VAS were fitted to a mixed‐effects repeated measures model that included patient as a random effect and baseline PRO value and time as fixed effects. Results are presented as least‐squares (LS) means with 95% CIs. The proportions of patients with clinically meaningful improvement or worsening at any time on study treatment were calculated with thresholds that were defined a priori and based on the published literature: a change of ≥10 points for the EORTC QLQ‐C30 scales and ≥7 points for the EQ‐5D‐5L VAS. 25 , 26 , 27
Median time to first worsening was calculated with the Kaplan–Meier method, and median time to first improvement was reported as a descriptive median. For this analysis, median time to improvement/worsening was defined as the first event a patient reported a meaningful improvement/worsening, with a distribution‐based meaningful change threshold defined as at least one half of one standard deviation from baseline. Death due to disease progression was included as worsening. Patients who had not met the definition of worsening were censored at the last PRO assessment.
RESULTS
Patient characteristics and compliance with PRO assessments
As of January 29, 2024, 154 patients had received talquetamab 0.8 mg/kg Q2W. Of these, phase 2 PRO data were available for 118 patients who received ≥1 dose of talquetamab during the study, with a median follow‐up of 23.4 months.
In the talquetamab PRO cohort ( n = 118), patients were aged a median of 67.5 years, and were mostly White (81.4%), male (62.7%), and not Hispanic or Latino (89.0%) (Table S1 ). The majority of patients had an Eastern Cooperative Oncology Group performance status of 1 and a median of five prior lines of therapy; 72% of patients were triple‐class refractory, and 27% of patients were penta‐class refractory. Mean EORTC QLQ‐C30 values at baseline were mostly worse than for the general population, and reflect the poor overall health status in this patient population (Figure 1 ). 28 Fatigue, pain, dyspnea, sleep disturbance, and appetite loss were among the worst symptom scores at baseline in the MonumenTAL‐1 patient population, and had suboptimal values compared with the general population 28 ; therefore, results for these symptom scales will be the focus in this article.
Compliance with completing the EORTC QLQ‐C30, EQ‐5D‐5L VAS, and PGIS assessments was >95% at screening and >80% at most posttreatment visits. The most common reasons for noncompliance were technical failure, the questionnaire not being provided by the site, or not specified.
Change in EORTC QLQ‐C30 domains and EQ‐5D‐5L VAS
Patients reported an overall worsening in GHS and most EORTC QLQ‐C30 functioning domains from baseline to cycle 1 (Figures 2 and 3A ), which suggests a worse HRQOL during talquetamab step‐up doses. However, improvements were noted after cycle 1 in most domains (Figures 2 and 3A ). Patients reported improvements in GHS that trended toward baseline at cycle 3, with further improvements beyond baseline at cycle 5 through cycle 21 (LS mean change, 4.9 points) (Figure 2 ; Table S2 ). Results for the EQ‐5D‐5L VAS were consistent with GHS (Figure 2 ). Physical functioning began improving at cycle 3, with sustained improvements at all cycles thereafter; at cycle 21, LS mean change from baseline improved by 5.0 points. Emotional functioning showed earlier improvements compared with other functioning scales at cycle 1 (LS mean change, 2.8 points), with notable improvements observed at cycle 21 (12.5 points). Role and social functioning worsened substantially compared with other functioning scales during cycle 1 (LS mean change, 10.1 and 12.9 points, respectively) but returned to baseline after cycle 3, and continued to be at or improved from baseline throughout treatment; at cycle 21, LS mean change from baseline improved by 1.7 and 6.9 points, respectively. Cognitive functioning remained relatively stable from baseline throughout treatment. Similar to the functioning scales, most EORTC QLQ‐C30 symptom domains had worse scores from baseline through cycle 1 but showed improvements thereafter (Figure 3B ; Table S2 ). Fatigue improved after cycle 3, and showed sustained improvements through cycle 21 (LS mean change, 4.0 points). Pain scores improved at all time points from cycle 1 onward, with notable improvements at cycle 21 (11.4 points). Dyspnea symptoms showed improvements from baseline as early as cycle 3 (LS mean change, 5.3 points), which were continued through cycle 21 (6.0 points). Sleep disturbance improved to baseline by cycle 3, and continued to be at or improved from baseline from cycle 3 onward. Appetite loss worsened through cycle 3 and then gradually improved toward baseline thereafter and returned to baseline at cycle 15, with further improvements noted at cycle 21 (LS mean change, 5.2 points).
Clinically meaningful improvements in EORTC QLQ‐C30 domains
Patients reported clinically meaningful improvements as early as cycle 1 in several of the EORTC QLQ‐C30 domains, and the proportion of patients with stable or clinically meaningful improvements generally increased throughout treatment (Figures S1 and S2 ). At cycle 21, meaningful improvements in GHS were observed (39% of patients); physical, role, and social functioning showed a majority of patients with stable or meaningful improvements (physical, 82%; role, 78%; social, 79%). Clinically meaningful improvements were evident in emotional functioning from cycle 1 (25%) through cycle 21 (52%). Meaningful improvements were also observed in fatigue, pain, dyspnea, and sleep disturbance at cycle 1 (39%, 31%, 20%, and 15%, respectively), with continued improvement or stabilization of symptoms at cycle 21 (60%, 84%, 88%, and 88%, respectively). Appetite loss worsened through cycle 3 (65% of patients) but improved or stabilized from cycle 5 onward (cycle 5, 56%; cycle 21, 87%).
Time to meaningful change
Median time to first improvement from baseline in the EORTC QLQ‐C30 was 2–3 months for most domains; cognitive functioning had the shortest time to improvement of less than 1 month. Median time to first improvement in EQ‐5D‐5L VAS scores was slightly longer than GHS (3.4 vs. 2.6 months). These early improvements support the LS mean change from baseline results, which demonstrates that after completing the step‐up doses, patients report better health outcomes.
Median time to first worsening from baseline in EORTC QLQ‐C30 was 2–18 months; role and social functioning had the shortest time to first worsening events. Median time to first worsening in EQ‐5D‐5L VAS scores was longer than GHS (5.8 vs. 3.1 months). Longer median time to first worsening was also reported in physical functioning (8.3 months), emotional functioning (17.9 months), and fatigue (11.3 months). The range for time to first worsening in EORTC QLQ‐C30 functioning and symptom scales was wide; as shown in Figure 3 and Figure S2 , for scales where time to first worsening event is short, scores improve after cycle 1 and remain around baseline or improve from baseline throughout treatment.
Patient global impression of MM severity
Consistent with the clinically meaningful improvement data, patients’ overall impression of the severity of their MM, as measured with the PGIS, improved from baseline (Figure 4 ). At baseline, 12% and 34% of patients classified their disease as either “very severe” or “severe,” respectively, which reduced to 3% at cycle 21 in each category. At baseline, 20% of patients reported their disease severity as “none” or “mild,” which increased to 61% of patients at cycle 21.
DISCUSSION
Although recent advances in MM treatment have improved efficacy outcomes, patients still experience a high burden of symptoms, poor prognosis, and ever‐declining quality of life. 8 , 29 , 30 , 31 This is, in part, due to the acute symptoms associated with treatment initiation as well as the cumulative effects of continuous immunosuppressive treatment such as steroids and novel therapies, in which immune compromise may be a consequence of highly effective drugs targeting antigens overexpressed on myeloma cells but also on healthy immune cells. 8 , 29 , 30 , 31 Because of this, patients’ HRQOL, at the start of as well as throughout treatment, is an important consideration when selecting the best therapeutic regimen for each patient, and represents an area of high unmet need. 31 This analysis from the MonumenTAL‐1 study demonstrates that patients treated with talquetamab 0.8 mg/kg Q2W had improvements in various patient‐reported measures, including overall health status, physical, emotional, and social functioning, pain, fatigue, and perceived disease severity, after an initial worsening from baseline through cycle 1 in a heavily pretreated patient population. These effects were maintained over both the short and long term (up to cycle 27), which indicates the durability of improvements over time.
MM carries the highest disease burden of all hematological cancers, with pain and fatigue among the largest contributors to poor quality of life. 31 , 32 In a UK cross‐sectional study involving over 550 patients with MM, >87% reported experiencing fatigue, and >70% reported experiencing pain. Of these, 21.9% and 13.8% rated their fatigue or pain as either “overwhelming” or “severe.” 31 Studies from Germany and the United States have reported similar findings. 8 , 33 In the current analysis, talquetamab improved patient‐reported pain and fatigue scores, and patients reported continued improvements with ongoing treatment. These results were observed despite heavy pretreatment, and provide a strong rationale for talquetamab use in patients with a high burden of disease and poor prognosis.
According to a published estimate, more than 75% of patients with RRMM experience emotional disturbance as a result of their disease. 33 In the current study, 25% of patients reported a clinically meaningful improvement in their emotional functioning after receiving just one cycle of talquetamab, and this proportion improved to approximately 50% in later cycles. This could be due to a rapid response that patients may have with treatment, which can have a large emotional boost in patients who may have been fearing the worst outcomes with treatment, especially in these heavily pretreated patients. Emotional functioning is one of several functioning domains in which patients reported meaningful improvements, and likely significantly affects their overall perception of HRQOL because emotional aspects, such as depression and anxiety, can worsen the overall MM symptom burden. Thus, the positive emotional impact evident with talquetamab treatment could have a particularly large impact on improving patients’ perceptions of their overall HRQOL. 34 This impact is reflected after cycles 3 and 4 in the EORTC QLQ‐C30 GHS, EQ‐5D‐5L VAS, and PGIS scales for this study, in which patients reported improvements in their health status, overall HRQOL, and global impression of their MM symptom/disease severity, respectively. Meaningful improvements in emotional functioning were observed despite temporary declines in functioning domains (physical, role, and social) and GHS and EQ‐5D‐5L VAS scores during the first few cycles. Emotional improvements are important to highlight in the context of the high response rates observed with talquetamab in MonumenTAL‐1, including in patients with high‐risk features (≥75 years of age, International Staging System stage III disease, high cytogenetic risk, triple‐class refractory, and penta‐drug refractory) who may have harder to treat disease and worse HRQOL. 3 , 13
Although talquetamab treatment overall was associated with improvements in each of the HRQOL measures assessed, initial worsening in various PRO domains was evident in the first few cycles of treatment, notably GHS, physical, role, and social functioning, and fatigue. There could be many potential reasons for these results, including the requirement for hospitalization for step‐up doses of talquetamab as a precaution for CRS, a common AE associated with T cell–redirecting therapies. 35 Hospital stays may reduce patient‐reported HRQOL and potentially contribute to the reported worsening PROs in cycle 1, as might the effects of CRS itself, which occurred in 73%–79% of patients across cohorts in MonumenTAL‐1, mostly during step‐up and the first full doses of talquetamab. 13 In addition, disease factors and symptoms of treatment initiation may contribute to the worsening of PRO results in the first few cycles of treatment. Notably, all of these domains improved starting at cycle 3, and improvements were generally maintained throughout treatment.
In the MonumenTAL‐1 study, patients receiving talquetamab may also experience GPRC5D‐related AEs, including oral‐related events such as dysgeusia. Dysgeusia is a condition that affects perception of taste, whereby all foods seem sour, sweet, bitter, or metallic. Across MonumenTAL‐1 cohorts, 71%–76% of patients experienced taste‐related changes (dysgeusia, hypogeusia, ageusia, and taste disorder); however, only three patients discontinued treatment because of taste‐related events. 13 These taste‐related changes could influence appetite loss or weight loss. In the current study, appetite loss peaked at cycle 3 and then trended toward baseline at subsequent cycles and returned to baseline at cycle 15, with some improvements beyond baseline through cycle 21. Although some patients had a slower recovery from appetite loss, most patients reported clinically stable or improvements in appetite loss from cycle 5 onward (cycle 5, 56%; cycle 21, 87%). The correlations of appetite loss in patients who also experienced taste‐related changes were not examined in this study; however, future analyses are planned to assess this association. As previously published, 34%–39% of patients across cohorts experienced weight loss (assessed by vital signs defined as 10% or greater weight loss from baseline) while receiving talquetamab treatment. 13 Weight loss was examined in patients with and without oral toxicities; data showed weight loss was evident early in cycle 1, and then stabilized around cycle 8 and improved thereafter over time. 13 Although weight loss and HRQOL correlative analyses were not assessed in this study, future analyses are planned to better assess this association.
Overall, the improvements observed in HRQOL, functioning, and symptoms were similar between the talquetamab 0.8 mg/kg Q2W schedule, presented in the current study, and talquetamab 0.4 mg/kg QW, previously published. 14 Although clinical results have shown both dose schedules to be equally effective, responses may potentially be more durable with the 0.8 mg/kg Q2W schedule. 16 Together with the favorable PROs observed with the 0.8 mg/kg Q2W schedule, these data support the convenience of a less frequent dosing option for patients receiving talquetamab.
This study has some limitations. The number of patients remaining on treatment declined over time, and no imputation was performed. Therefore, sample sizes for later cycles were small, which limits the strength of the conclusions that can be drawn. A decline in the number of patients was noted from baseline to cycle 3; however, compliance rates for PRO assessments remained consistent throughout this period and thereafter. Kaplan–Meier analyses for median time to worsening outcomes are relative to baseline rather than a patient’s prior assessment, and do not show the long‐term outcomes of patients with this analysis. There is a potential for responder bias. Given that MonumenTAL‐1 is a phase 1/2 study and talquetamab is relatively early in its development cycle, the PRO assessment tools used in the study assessed overall HRQOL and general cancer‐related symptoms and impacts; therefore, GPRC5D‐related AEs were not captured. Other ongoing studies use additional assessment tools, including the PRO‐CTCAE, Short Xerostomia Inventory, Epstein Taste Scale, Scale of Subjective Total Taste Acuity, and qualitative interviews to evaluate HRQOL as it relates to GPRC5D‐related AEs. 36 Finally, MonumenTAL‐1 is a single‐arm, nonblinded study, and included a heavily pretreated patient population; ongoing and future phase 3 studies will investigate PROs associated with talquetamab in earlier lines of therapy. Notwithstanding these limitations, we consider this article to have several key strengths; notably, that measuring PROs was a prespecified secondary end point, not a post hoc analysis, and that its key results were consistent across various PRO instruments and domains.
In conclusion, patients receiving talquetamab 0.8 mg/kg Q2W reported improvements from baseline in physical, emotional, and social functioning and overall HRQOL, as well as in MM symptoms including pain and fatigue. Although appetite did not return to baseline levels until cycle 15, GHS and EQ‐5D‐5L VAS scores showed improvements during this time, which suggests that appetite loss did not largely affect overall HRQOL. These PRO results along with the clinical efficacy and safety profile of talquetamab shown in the primary analysis of MonumenTAL‐1 support talquetamab as a compelling treatment option for patients with triple‐class exposed RRMM.
AUTHOR CONTRIBUTIONS
Carolina Schinke : Writing—review and editing; investigation. Cyrille Touzeau : Writing—review and editing; investigation. Albert Oriol : Writing—review and editing; investigation. María‐Victoria Mateos : Writing—review and editing; investigation. Don Stevens : Writing—review and editing; investigation. Leo Rasche : Writing—review and editing; investigation. Xiang Qin : Writing—review and editing. Kelly Kato : Writing—review and editing. Sacheeta Bathija : Writing—review and editing. Eva G. Katz : Writing—review and editing. Katharine S. Gries : Writing—review and editing. Michela Campagna : Writing—review and editing. Tara Masterson : Writing—review and editing. Brandi W. Hilder : Writing—review and editing. Jaszianne Tolbert : Writing—review and editing; supervision. Thomas Renaud : Writing—review and editing; supervision. Christoph Heuck : Writing—review and editing; supervision. Chalmer Tomlinson : Writing—review and editing. Philippe Moreau : Writing—review and editing. Jesús San‐Miguel : Writing—review and editing. Paula Rodríguez‐Otero : Writing—review and editing. Ajai Chari : Writing—review and editing.
CONFLICT OF INTEREST STATEMENT
Carolina Schinke has received honoraria from Johnson & Johnson and Pfizer, and has participated in advisory board meetings for Arcellx, Johnson & Johnson, and Pfizer. Cyrille Touzeau has received honoraria from Bristol‐Myers Squibb (BMS) and Janssen Biotech, and serves as a member on the board of directors or advisory committee for BMS. Albert Oriol has received honoraria from Amgen, BMS, GlaxoSmithKline (GSK), Janssen Biotech, Johnson & Johnson, Menarini, Oncopeptides, Pfizer, and Sanofi, and serves as a member on the board of directors or advisory committee for BMS, GSK, Johnson & Johnson, Menarini, Oncopeptides, Pfizer, and Sanofi. María‐Victoria Mateos has received honoraria from AbbVie, Amgen, BMS/Celgene, GSK, Johnson & Johnson, Kite Pharma, Oncopeptides, Pfizer, Regeneron, Roche, Sanofi, Stemline, and Takeda; is a member of a board of directors or advisory committee for AbbVie, BMS/Celgene, GSK, Janssen Global Services, Johnson & Johnson, Oncopeptides, Pfizer, Sanofi, Stemline, and Takeda; and is a speakers’ bureau member for Johnson & Johnson. Leo Rasche has received honoraria from BMS, GSK, Johnson & Johnson, Pfizer, Roche, and Sanofi; is a member of a board of directors or advisory committee for Amgen, BMS, Johnson & Johnson, Pfizer, and Sanofi; is a consultant for Amgen, BMS, GSK, Johnson & Johnson, Pfizer, and Sanofi; has received travel support from BeiGene and Johnson & Johnson; and has received research funding from BMS, GSK, Sanofi, and SkylineDx. Xiang Qin, Kelly Kato, Sacheeta Bathija, Eva G. Katz, Katharine S. Gries, Michela Campagna, Tara Masterson, Brandi W. Hilder, Jaszianne Tolbert, Thomas Renaud, Christoph Heuck, and Chalmer Tomlinson are employees of Johnson & Johnson and may hold stock, stock options, or equity in Johnson & Johnson. Philippe Moreau has received honoraria from and is a member of an advisory board for AbbVie, Amgen, BMS/Celgene, GSK, Janssen Biotech, Johnson & Johnson, Pfizer, Sanofi, and Takeda. Jesús San‐Miguel is a consultant and advisory board member for AbbVie, Amgen, BMS/Celgene, GSK, HaemaLogiX, Johnson & Johnson, Karyopharm, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi, Secura Bio, and Takeda. Paula Rodríguez‐Otero is a consultant for AbbVie, BMS, H3 Biomedicine, Janssen Global Services, Pfizer, Roche, and Stemline; is a member of a board of directors or advisory committee for AbbVie, BMS, GSK, Johnson & Johnson, Kite Pharma, Oncopeptides, Pfizer, Sanofi, and Takeda; and has received honoraria from Amgen, BMS, GSK, Janssen Pharmaceuticals, Johnson & Johnson, Regeneron, Sanofi, and Takeda. Ajai Chari is a consultant for Adaptive Biotechnologies, Amgen, Antengene, BMS, Janssen Pharmaceuticals, Johnson & Johnson, Millenium/Takeda, and Secura Bio; is a member of an advisory board for AbbVie, Amgen, BMS, Genentech, GSK, Johnson & Johnson, Karyopharm, Sanofi, Seattle Genetics, Secura Bio, and Shattuck Labs; and has received research funding from Amgen, BMS, Johnson & Johnson, Millenium/Takeda, and Seattle Genetics. The other author declares no conflicts of interest.
Supporting information
Supplementary Material S1
ACKNOWLEDGMENTS
The authors thank all study participants. Medical writing support was provided by Alana Dorfstatter PharmD of Eloquent Scientific Solutions, which was funded by Johnson & Johnson. This study was funded by Johnson & Johnson. Johnson & Johnson was involved in the study design, data collection, data analysis, and preparation of the manuscript.
DATA AVAILABILITY STATEMENT
The data sharing policy of Johnson & Johnson is available at https://www.janssen.com/clinical‐trials/transparancy . As noted on this site, requests for access to the study data can be submitted via the Yale University Open Data Access Project site at http://yoda.yale.edu .
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