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Mirvetuximab soravtansine in folate receptor alpha (FRα)–high platinum-resistant ovarian cancer: final overall survival and post hoc sequence of therapy subgroup results from the SORAYA trial
  1. Robert L Coleman1,
  2. Domenica Lorusso2,
  3. Ana Oaknin3,
  4. Sabrina Chiara Cecere4,
  5. Hannelore Denys5,
  6. Nicoletta Colombo6,7,
  7. Toon van Gorp8,
  8. Jason A Konner9,
  9. Margarita Romeo Marin10,
  10. Philipp Harter11,
  11. Conleth Murphy12,
  12. Yuemei Wang13,
  13. Brooke Esteves13,
  14. Michael Method13 and
  15. Ursula Matulonis14
    1. 1 US Oncology Research, Texas Oncology, The Woodlands, Texas, USA
    2. 2 Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
    3. 3 Gynaecologic Cancer Programme, Vall d'Hebron Institute of Oncology, Barcelona, Spain
    4. 4 Department of Experimental Uro-Gynecological Oncology, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy
    5. 5 Ghent University Hospital, Ghent, Belgium
    6. 6 European Institute of Oncology IRCCS Library, Milan, Italy
    7. 7 University of Milan-Bicocca, Milan, Italy
    8. 8 Leuven Cancer Institute, University Hospitals Leuven, Leuven, Belgium
    9. 9 Memorial Sloan Kettering Cancer Center, New York, New York, USA
    10. 10 Institut Català d'Oncologia, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
    11. 11 KEM Kliniken Essen-Mitte, Essen, Germany
    12. 12 Cancer Centre and Cancer Trials, Bon Secours Hospital Cork, Cork, Ireland
    13. 13 ImmunoGen Inc, Waltham, Massachusetts, USA
    14. 14 Dana Farber Cancer Institute, Boston, Massachusetts, USA
    1. Correspondence to Dr Robert L Coleman, US Oncology Research, Texas Oncology, The Woodlands, TX 77380, USA; rcoledude{at}mac.com

    Abstract

    Objective The single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in folate receptor alpha (FRα)–high platinum-resistant ovarian cancer (n=105 (efficacy-evaluable)) met its primary endpoint with an objective response rate of 32.4% (95% CI, 23.6 to 42.2). Here we report final SORAYA trial results for overall survival and post hoc objective response rates in subgroups by sequence and number of prior therapies.

    Methods Eligible patients had high-grade serous platinum-resistant ovarian cancer with high FRα expression and one to three prior therapies (prior bevacizumab required). Enrolled participants received 6 mg/kg mirvetuximab soravtansine-gynx adjusted ideal body weight intravenously once every 3 weeks until progressive disease, unacceptable toxicity, withdrawal of consent, or death. Final overall survival and post hoc objective response rates were assessed in efficacy-evaluable participants. The safety population included all patients who received ≥1 dose of mirvetuximab soravtansine-gynx.

    Results At data cut-off (December 22, 2022; n=105), final median overall survival was 15.0 months (95% CI, 11.5 to 18.7). Median overall survival in participants with one to two prior therapy lines was 18.7 months (95% CI, 13.8 to not estimable (NE)) and 11.6 months (95% CI, 7.1 to 16.7) with three prior therapy lines. Median overall survival was 15.0 months (95% CI, 11.5 to NE) in participants with prior poly (ADP-ribose) polymerase inhibitor (PARPi) treatment versus 14.0 months (95% CI, 7.1 to NE) in those without. Objective response rate (data cut-off: November 17, 2021) differed among participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting (34.8%; 95% CI, 23.5 to 47.6) versus a different first treatment (28.2%; 95% CI, 15.0 to 44.9) or had received prior bevacizumab in a platinum-sensitive (34.0%; 95% CI, 24.6 to 44.5) versus platinum-resistant setting (17.6%; 95% CI, 3.8 to 43.4). No new safety signals were observed.

    Conclusion These results support the clinically meaningful efficacy of mirvetuximab soravtansine-gynx in FRα-expressing platinum-resistant ovarian cancer, irrespective of prior treatment or sequence.

    • Ovarian Neoplasms
    • Ovarian Cancer

    Data availability statement

    Data are available upon reasonable request. The study sponsor, ImmunoGen, Inc., is committed to the responsible sharing of clinical trial data. The research protocol has been published previously and data from this clinical trial can be requested by any qualified investigator who engages in relevant research. In accordance with the Journal’s guidelines, we will provide our data for independent analysis by a team selected by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

    http://creativecommons.org/licenses/by-nc/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, an indication of whether changes were made, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    WHAT IS ALREADY KNOWN ON THIS TOPIC

    • The current standards of care in platinum-resistant ovarian cancer have limited anticancer activity and high rates of cytotoxicity in this patient population with a historically poor prognosis and survival outcomes. Mirvetuximab soravtansine-gynx is an antibody–drug conjugate targeting folate receptor alpha (FRα), which is highly expressed in ovarian cancer. As previously reported, the single-arm, phase II SORAYA trial (NCT04296890) of mirvetuximab soravtansine-gynx in FRα-expressing, platinum-resistant ovarian cancer met its primary endpoint with an objective response rate of 32.4% (95% CI, 23.6–42.2).

    WHAT THIS STUDY ADDS

    • Here we report final overall survival and post hoc objective response rate subgroup data from the SORAYA study; clinically relevant subgroups evaluated include participants with one to two, or three, prior lines of therapy, prior poly (ADP-ribose) polymerase inhibitor (PARPi) treatment, participants who received bevacizumab in the platinum-sensitive versus platinum-resistant setting, and participants who received mirvetuximab soravtansine-gynx as their first therapy in the platinum-resistant setting versus a different first therapy.

    HOW THIS STUDY MIGHT AFFECT RESEARCH, PRACTICE OR POLICY

    • Results from this updated analysis further demonstrate the clinically meaningful efficacy of mirvetuximab soravtansine-gynx, irrespective of either prior treatment or sequence, and align with previous findings in other studies of mirvetuximab soravtansine-gynx such that no new safety signals were observed. These results, in conjunction with the consistent anticancer activity and safety profile observed with mirvetuximab soravtansine-gynx across other clinical trials, position mirvetuximab soravtansine-gynx as a practice-changing therapeutic option for patients with platinum-resistant ovarian cancer.

    Introduction

    The shortage of effective, targeted treatments for patients with platinum-resistant ovarian cancer represents a significant unmet need.1 Mirvetuximab soravtansine-gynx is an antibody–drug conjugate that targets folate receptor alpha (FRa) and induces a directed cytotoxic effect through a tubulin-targeting payload (maytansinoid DM4).2 Recently published results from the single-arm, phase II SORAYA trial (NCT04296890) found that mirvetuximab soravtansine-gynx monotherapy in patients with FRa-high platinum-resistant ovarian cancer (n=105 (efficacy-evaluable)) elicited an investigator-assessed confirmed objective response rate of 32.4% (95% CI, 23.6 to 42.2), including 5 complete and 29 partial responses.3 The investigator-assessed median duration of response was 6.9 months (95% CI, 5.6 to 9.7). These results supported accelerated approval of mirvetuximab soravtansine-gynx by the US Food and Drug Administration (FDA; November 14, 2022) for adult patients with FRa-positive, platinum-resistant ovarian cancer who received one to three prior systemic treatments.4 5

    We report updated results from the SORAYA trial for final overall survival and post hoc subgroup analyses to preliminarily evaluate the impact of sequence and number of prior therapies on clinical outcomes with mirvetuximab soravtansine-gynx.

    Methods

    The SORAYA trial design, methodology, study protocol, and primary analysis have been published previously.3 SORAYA was a single-arm, phase II trial that recruited 106 participants from 39 sites in 8 countries (ClinicalTrials.gov ID: NCT04296890).6 Enrolled participants had a confirmed diagnosis of high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer; were ≥18 years old; platinum-resistant disease; high FRa expression (≥75% of cells with ≥2+ immunohistochemical staining intensity as defined by the FDA-approved VENTANA FOLR1 (FOLR1-2.1) RxDx Assay);7 and one to three prior lines of systemic anticancer therapy (bevacizumab required). Participants received mirvetuximab soravtansine-gynx monotherapy at 6 mg/kg adjusted ideal body weight once every 3 weeks until progressive disease, unacceptable toxicity, or death. The primary endpoint was investigator-assessed objective response rate by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. All participants who discontinued mirvetuximab soravtansine-gynx were followed for survival every 3 months (±1 month) until death, loss to follow-up, withdrawal of consent to follow-up, or end of study.8 Efficacy-evaluable participants had ≥1 measurable lesion (RECIST version 1.1).

    Final overall survival was estimated using the Kaplan–Meier method in the overall efficacy-evaluable population and in participants who received one to two versus three prior lines of treatment and those with prior poly (ADP-ribose) polymerase inhibitor (PARPi) treatment versus PARPi-naïve. Post hoc analyses evaluated objective response rate in the following subgroups: participants who had mirvetuximab soravtansine-gynx administered as the first treatment in the platinum-resistant setting versus a different first treatment in the platinum-resistant setting, and participants by timing of prior bevacizumab exposure (ie, in the platinum-sensitive or platinum-resistant setting). Adverse events were evaluated based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and coded using the Medical Dictionary for Regulatory Activities, version 24.0. Statistical analyses were performed using SAS version 9.4 (Cary, NC, USA).

    The study was funded by ImmunoGen, Inc. and performed according to the principles of the Declaration of Helsinki, Good Clinical Practice guidelines of the International Council for Harmonisation, and local regulatory requirements. A central institutional review board (WCG WIRB; Approval Number: 20200077), along with an independent ethics committee at each investigative site, approved the protocol. All participants (or legally authorized representatives) provided written informed consent.

    Results

    Participants

    Of the 467 patients screened, 106 participants were enrolled from June 2020 to May 2021 (participant flow diagram has been published previously).3 Baseline characteristics are summarized in Table 1.3 Of those enrolled, 37% received prior treatment in the platinum-resistant setting. All participants received prior bevacizumab, 48% received one to two prior lines of therapy, 51% received three prior lines of therapy, and 48% received a prior PARPi. At the time of data cut-off for the final overall survival and safety analyses (December 22, 2022), median duration of mirvetuximab soravtansine-gynx treatment was 4.2 (range, 0.7–22.1) months, with 28 participants receiving mirvetuximab soravtansine-gynx for >7 months.

    Table 1

    Patients' baseline demographics and clinical characteristics3

    Efficacy

    The final median overall survival in the efficacy-evaluable population (n=105) was 15.0 months (95% CI, 11.5 to 18.7), with 37% of participants alive at year 2 and a median follow-up of 20.0 months (95% CI, 19.0 to 20.6) (Figure 1A). In participants with one to two prior lines of therapy (n=51), median overall survival was 18.7 months (95% CI, 13.8 to not estimable (NE)) versus 11.6 months (95% CI, 7.1 to 16.7) in participants with three prior lines of therapy (n=53) (Figure 1B). In participants who received prior PARPi (n=50), median overall survival was 15.0 months (95% CI, 11.5 to NE) versus 14.0 months (95% CI, 7.1 to NE) in PARPi-naïve participants (n=51).

    Figure 1

    Final overall survival and post hoc subgroup analyses by sequence and number of prior therapies. Shown are Kaplan–Meier plots (data cut-off: December 22, 2022) of final overall survival in (A) the efficacy-evaluable population and (B) in participants who had one to two prior lines of therapy (blue) versus three prior lines of therapy (red). (C) Shows objective response rate (data cut-off: November 17, 2021) in the overall population and post hoc analysis results for objective response rate in participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting versus a different first treatment in the platinum-resistant setting and in participants who were first exposed to bevacizumab in the platinum-sensitive versus platinum-resistant setting. aOne patient in the efficacy-evaluable population had four prior lines of therapy. bOf the 17 participants who received bevacizumab in the platinum-resistant setting (16% of all participants), 8 (47%) had stage IV disease at diagnosis and 10 (59%) received mirvetuximab soravtansine-gynx as fourth-line therapy. Six participants (6% of all participants) received bevacizumab in both the platinum-sensitive and platinum-resistant settings.

    As reported previously, investigator-assessed objective response rate was 32.4% (95% CI, 23.6 to 42.2) in the efficacy-evaluable population (n=105).3 Post hoc subgroup analyses (data cut-off: November 17, 2021) (Figure 1C) demonstrated that participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting (n=66) had an objective response rate of 34.8% (95% CI, 23.5 to 47.6), and those who received prior treatment in the platinum-resistant setting (n=39) had an objective response rate of 28.2% (95% CI, 15.0 to 44.9). Participants who received bevacizumab in the platinum-sensitive setting (n=94) had an objective response rate of 34.0% (95% CI, 24.6 to 44.5) versus 17.6% (95% CI, 3.8 to 43.4) in the platinum-resistant setting (n=17).

    Safety

    Analyses of safety data (data cut-off: December 22, 2022) identified no new safety signals (Table 2).3 Treatment-related adverse events occurred in 86% of the safety population (n=106), with 30% having a grade 3–4 event. The most common (≥20% of participants) treatment-related adverse events (all grades, grade 3–4) were visual impairment (43%, 6%), fatigue (37%, 2%), keratopathy (36%, 9%), nausea (29%, 0%), peripheral neuropathy (27%, 3%), dry eye (25%, 2%), and diarrhea (22%, 2%).

    Table 2

    Most common (≥10%) treatment-related adverse events in the safety population (N=106)

    Discussion

    Summary of main results

    The final median overall survival of 15.0 months and lack of new safety signals from the SORAYA trial further support the clinical benefit of mirvetuximab soravtansine-gynx in patients with FRα-expressing, platinum-resistant ovarian cancer. Although no formal statistical comparisons were performed, and therefore all descriptive findings in this article are restricted by this inherent limitation, subgroup analyses identified potential differences in clinical outcomes among participants based on sequence and/or number of prior lines of therapy. Participants with one to two prior lines of therapy demonstrated slightly longer median overall survival (18.7 months) versus participants with three prior lines of therapy (11.6 months), though no statistical comparison was performed. The median overall survival in subgroups by previous PARPi exposure was similar to the median overall survival in the total population (overall, 15.0 months; prior PARPi, 15.0 months; PARPi-naïve, 14.0 months) suggesting limited impact of prior PARPi treatment on mirvetuximab soravtansine-gynx efficacy. Additionally, participants who received mirvetuximab soravtansine-gynx as their first treatment in the platinum-resistant setting had a moderately higher objective response rate versus participants who did not (34.8% vs 28.2%), though no statistical comparison was performed.

    Follow-up safety data provided from this study showed no new safety signals with mirvetuximab soravtansine-gynx. The most common adverse events (visual impairment, fatigue, keratopathy, nausea, peripheral neuropathy, dry eye, and diarrhea) and overall rate of grade 3–4 treatment-related adverse events (30%) were consistent with initial reports from the SORAYA trial and other trials of mirvetuximab soravtansine-gynx monotherapy.3 9 10 Further, grade 3–4 ocular treatment-related adverse events were limited (visual impairment, 6%; keratopathy, 9%; and dry eye, 2%), indicating that prophylactic and mitigative procedures for ocular adverse events continued to be effective in the vast majority of patients despite continued mirvetuximab soravtansine-gynx exposure.

    Results in the context of published literature

    Minimal or no improvements in overall survival have been observed in trials among patients with platinum-resistant ovarian cancer, which underscores the challenge of identifying effective treatments for this population. In recent phase III randomized trials of monotherapy in platinum-resistant ovarian cancer, median overall survival was 11.4 months versus 10.9 months with lurbinectedin versus chemotherapy (CORAIL trial; HR, 0.96; 95% CI, 0.77 to 1.18; p=0.679)11 and 10.1 months versus 12.1 months with nivolumab versus chemotherapy (NINJA trial; HR, 1.0; 95% CI, 0.8 to 1.3; p=0.808).12 While trials of combination therapy in platinum-resistant ovarian cancer have demonstrated numerically longer median overall survival with various therapies plus chemotherapy, improvements in overall survival have not been statistically significant compared with chemotherapy alone (AURELIA trial (bevacizumab plus chemotherapy) overall survival HR, 0.85; 95% CI, 0.66 to 1.08; p<0.174; JAVELIN 2000 trial (avelumab plus chemotherapy) overall survival HR, 0.89; repeated 88.85% CI, 0.74 to 1.24; p=0.21).13 14

    Crucially, the final SORAYA trial results for overall survival in the current report are notable and further corroborate the results from the confirmatory, randomized, phase III MIRASOL trial (NCT04209855) in FRa-expressing, platinum-resistant ovarian cancer (data cut-off: March 6, 2023), which showed statistically significant improvements in the key secondary endpoint of overall survival with mirvetuximab soravtansine-gynx monotherapy versus single-agent chemotherapy (median, 16.46 months vs 12.75 months; HR, 0.67; 95% CI, 0.50 to 0.89; p=0.005).9 Results from the MIRASOL trial also demonstrated significant improvement with mirvetuximab soravtansine-gynx versus chemotherapy in investigator-assessed progression-free survival (primary endpoint; median, 5.62 months vs 3.98 months; HR, 0.65; 95% CI, 0.52 to 0.81; p<0.001) and objective response rate (key secondary endpoint; 42.3% vs 15.9%; OR, 3.81; 95% CI, 2.44 to 5.94; p<0.001).9 15 Altogether, these results are unprecedented as mirvetuximab soravtansine-gynx is the first novel therapy to demonstrate a survival benefit over chemotherapy in a phase III trial of platinum-resistant ovarian cancer.11–13

    The current analyses from the SORAYA trial showed that the demonstrated overall survival benefit of mirvetuximab soravtansine-gynx persists regardless of prior lines of therapy and previous PARPi exposure. However, participants who had received one to two prior lines of therapy demonstrated slightly longer overall survival than those who had received three prior lines of therapy (median overall survival, 18.7 months vs 11.6 months). This finding is in line with the well-documented observation that survival outcomes decrease with each additional line of therapy,16 17 which may be due to treatment resistance as well as diminished ability of a patient to withstand treatment due to cumulative toxicity. Conversely, mirvetuximab soravtansine-gynx demonstrated similar median overall survival regardless of prior PARPi exposure, which suggests that mirvetuximab soravtansine-gynx’s mechanism of action succeeds in patients who were previously selected for a PARPi. Future studies should investigate the efficacy of mirvetuximab soravtansine-gynx in patients who progress on PARPi to better understand the clinical benefit of mirvetuximab soravtansine-gynx in these patients, as well as the underlying molecular/clinical features of these patients.

    Of note, previously observed objective response rates with third- or fourth-line chemotherapy in heavily pre-treated patients with platinum-resistant or platinum-refractory ovarian cancer have been low (3.1% or 1.6%, respectively).18 Thus, the objective response rate of 17.6% among participants in the current study who had been treated with bevacizumab in the platinum-resistant setting (n=17; 16% of all participants) is notable given 59% (n=10/17) received mirvetuximab soravtansine-gynx as fourth-line therapy and 35% (n=6/17) received bevacizumab in both the platinum-sensitive and platinum-resistant settings.

    Lastly, in other phase III platinum-resistant ovarian cancer monotherapy trials previously described, patients receiving chemotherapy had grade ≥3 treatment-related adverse events at rates of 59%–65% (compared with 30% reported here with mirvetuximab soravtansine-gynx).11–13 Thus, the final follow-up safety results from the SORAYA trial further demonstrate the favorable and differentiated tolerability profile of mirvetuximab soravtansine-gynx.

    Strengths and weaknesses

    An important strength of this trial is that it included a more heavily pre-treated population than recent phase III clinical trials in platinum-resistant ovarian cancer.11–14 The differentiated safety profile and demonstrated anticancer activity even in heavily pre-treated patients underscores the potential for mirvetuximab soravtansine-gynx to meet an unmet clinical need in this patient population. Limitations of this trial include its nonrandomized design, eligibility criteria that limited enrollment to participants who received one to three prior lines of therapy, and lack of formal statistical comparisons for the subgroup analyses due to insufficient power to detect differences in the small sample sizes. The generalizability of these results is therefore limited by the hypothesis-generating nature of the analyses.

    Implications for practice and future research

    Although additional investigation is warranted to confirm these observations, it is reasonable to consider initiating mirvetuximab soravtansine-gynx therapy earlier in the treatment journey for patients in the platinum-resistant setting, with or without bevacizumab (as studied in the FORWARD II trial (NCT02606305) of mirvetuximab soravtansine-gynx plus bevacizumab).19 These data underscore the clinical benefit of mirvetuximab soravtansine-gynx as an effective treatment option with a tolerable safety profile for patients with platinum-resistant ovarian cancer irrespective of whether a patient received up to three lines of prior therapy or bevacizumab in either the platinum-sensitive or platinum-resistant setting. Understanding the use of mirvetuximab soravtansine-gynx in this patient population with a historically poor prognosis represents a crucial advancement in identifying patients who may benefit from this therapy.

    Conclusions

    These results, in conjunction with the consistent anticancer activity and safety profile observed with mirvetuximab soravtansine-gynx across other clinical trials, provide important insights and position mirvetuximab soravtansine-gynx as a practice-changing therapeutic option for individuals living with platinum-resistant ovarian cancer.

    Data availability statement

    Data are available upon reasonable request. The study sponsor, ImmunoGen, Inc., is committed to the responsible sharing of clinical trial data. The research protocol has been published previously and data from this clinical trial can be requested by any qualified investigator who engages in relevant research. In accordance with the Journal’s guidelines, we will provide our data for independent analysis by a team selected by the Editorial Team for the purposes of additional data analysis or for the reproducibility of this study in other centers if such is requested.

    Ethics statements

    Patient consent for publication

    Ethics approval

    This study involves human participants and was performed according to the principles of the Declaration of Helsinki, Good Clinical Practice guidelines of the International Council for Harmonisation, and local regulatory requirements. The institutional review board or independent ethics committee at each investigative site approved the protocol. All participants (or legally authorized representatives) provided written informed consent. Participants gave informed consent to participate in the study before taking part.

    Acknowledgments

    We wish to thank all the patients who participated and their families, as well as co-investigators, nurses, study coordinators, and operations staff at each of the clinical sites. Medical writing and editorial support were provided by Gloria Marino Bravante, PhD, and Amanda Agazio, PhD, CMPP, of PRECISIONscientia (Yardley, PA, USA) and funded by ImmunoGen, Inc.

    References

    Footnotes

    • X @rcoledude, @DenysHannelore, @MargaRomeo

    • Contributors Each of the authors have made substantial contributions to the study design, investigation, and/or data analysis and interpretation. In accordance with recommendations from the International Committee of Medical Journal Editors, all authors contributed substantially to the intellectual content of the manuscript and have approved the final manuscript for submission to the International Journal of Gynecological Cancer. RLC is responsible for the overall content. This clinical trial update is an original submission; however, some results were presented in an oral presentation at the Society of Gynecological Oncology (SGO) Annual Meeting 2023 (Coleman R, et al. Gynecol Oncol. 2023;176(Suppl.):S3). ImmunoGen, Inc. sponsored the study; contributed to its design; and participated in the collection, analysis, and interpretation of the data. Medical writing and editorial support were provided by PRECISIONscientia (Yardley, PA, US) and funded by ImmunoGen, Inc.

    • Funding This study was funded by ImmunoGen, Inc.

    • Competing interests RLC: Research funding and consulting or advisory fees: AstraZeneca/MedImmune, Clovis Oncology. Consulting and advisory fees: Genentech/Roche, Genmab, Tesaro, OncoMed, Sotio, Oncolytics, AbbVie/Stemcentrx, ImmunoGen, AbbVie, Agenus, Novocure, Merck, OncXerna Therapeutics, Alkermes, Gradalis, Regeneron. Research funding: AstraZeneca, Merck, Roche/Genentech, Abbott/AbbVie, ImmunoGen. DL: Research funding and consulting or advisory fees: PharmaMar, Clovis Oncology, GSK, MSD, AstraZeneca, Amgen, Seagen/Genmab, Sutro, ImmunoGen, Merck Serono. Research funding: Clovis, Incyte, Novartis, Roche, Concept. AO: Research funding and consulting or advisory fees: Clovis Oncology, Eisai Limited, F. Hoffmann-La Roche. Consulting or advisory fees: Roche, AstraZeneca, PharmaMar, Tesaro, ImmunoGen, Genmab, Mersana Therapeutic, GSK, Deciphera Pharmaceutical, AGENUS, Corcept Therapeutics, Eisai, EMD Serono, Got It Consulting, KL Logistics, Medison Pharma, Merck Sharp & Dohme, Novocure, prIME Oncology, Sattucklabs, Sutro Biopharma, iTheos. Research funding: AbbVie Deutschland, Ability Pharmaceuticals, Advaxis Inc., Aeterna Zentaris, AMGEM, SA, Aprea Therapeutics, AB, Regeneron Pharmaceuticals. SCC: Research funding and consulting or advisory fees: Roche, Pfizer. Consulting or advisory fees: PharmaMar, Tesaro, Clovis Oncology. Research funding: AstraZeneca, MSD. HD: Consulting or advisory fees: Pfizer, Roche, PharmaMar, AstraZeneca, Eli Lilly and Company, Novartis, Amgen, GSK, MSD, Seagen, and Gilead. Travel, accommodations, expenses: Pfizer, Roche, PharmaMar, Teva, AstraZeneca, MSD, GSK and Gilead. Research grant: Gilead. All payments institutional. NC: Consulting or advisory fees: Roche/Genentech, AstraZeneca, Clovis Oncology, Pfizer, MSD Oncology, Tesaro, GSK, ImmunoGen, Pfizer, Mersana, Eisai, Advaxis. TvG: Consulting or advisory fees: AstraZeneca, BioNTech SE, Eisai, GSK, ImmunoGen, Incyte, MSD/Merck, OncXerna Therapeutics, Seagen, and Tubulis. Travel, accommodations, and/or expenses: AstraZeneca, GSK, ImmunoGen, MSD/Merck, and PharmaMar. Research funding: Amgen, Roche, and AstraZeneca. All payments institutional. JAK: Consulting or advisory fees: AstraZeneca, Clovis Oncology. Research funding: ImmunoGen. MRM: Consulting or advisory fees: Tesaro/Glaxo, AstraZeneca, Roche, Eisai, Pfizer. PH: Honoraria: Amgen, AstraZeneca, GSK, Roche, Sotio, Stryker, Zai Lab, MSD, Clovis, Eisai, Mersana, Exscientia. Advisory Board: AstraZeneca, Roche, GSK, Clovis, ImmunoGen, MSD, Miltenyi, Novartis, Eisai. Institutional research funding: AstraZeneca, Roche, GSK, Genmab, DFG, European Union, DKH, ImmunoGen, Seagen, Clovis Oncology, Novartis. CM: Honoraria: Janssen Pharmaceuticals. Travel, accommodations, and/or expenses: Pfizer, Inc., Bayer AG. YW: ImmunoGen employee. BE: ImmunoGen employee. MM: ImmunoGen employee. UM: Consulting or advisory fees: NextCure, Allarity, Ovarian Cancer Research Alliance, Pfizer, Profound Bio, Eisai, CureLab, ImmunoGen, Trillium, Agenus, Novartis, Boehringer Ingelheim. Participation in a Data Safety Monitoring Board: Alkermes, Symphogen. Speakers Bureau: Med Learning Group.

    • Provenance and peer review Not commissioned; externally peer reviewed.