{"ok":true,"data":{"subject":{"kind":"trial","nctId":"NCT05615636","title":"A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL","sponsor":"M.D. Anderson Cancer Center","phases":["PHASE2"],"status":"RECRUITING","indication":null,"disease":"Hodgkins lymphoma"},"rows":[{"n":1,"question":"Is the biology right?","flags":[{"id":"somatic_driver","label":"Somatic driver evidence","value":"yes","detail":"CD79B in Hodgkins lymphoma","rule":"Open Targets has somatic-mutation evidence for the target in this cancer","source":{"label":"Open Targets: CD79B in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000007312/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"},"context":[{"figure":"2.3× relative success for targets with somatic (IntOGen) support in oncology","dataset":"Minikel et al., Nature 2024","years":"drug programs to 2023","caveat":"A ratio between groups, not a probability for this program; mostly phase 2 to 3."}]},{"id":"human_genetic","label":"Human genetic evidence","value":"yes","detail":"CD79B: somatic","rule":"Any germline or somatic human genetic evidence for the target in this cancer, counted apart from animal-model and literature evidence","source":{"label":"Open Targets: CD79B in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000007312/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"},"context":[{"figure":"2.6× relative probability of success, phase 1 to launch, with human genetic support","dataset":"Minikel et al., Nature 2024","years":"drug programs to 2023","caveat":"All therapy areas, mostly germline evidence; not a probability for this program."}]},{"id":"pediatric_target","label":"Pediatric target","value":"yes","detail":"CD79B, CD19 on the FDA list","rule":"Target is on FDA's Pediatric Molecular Target List (relevant targets); membership alone neither requires nor waives a study","source":{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"},"context":[]},{"id":"haematologic","label":"Haematologic cancer","value":"yes","detail":"Haematologic","rule":"From the indication, or the registry conditions when no indication matches","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},"context":[{"figure":"Likelihood of approval from phase 1: 7.5% haematologic vs 4.6% solid","dataset":"BIO / Informa / QLS 2021","years":"2011–2020","caveat":"Population-level, not a prediction."}]}],"facts":[{"label":"Background therapy","text":"Lenalidomide: standard agents, not counted in these flags."},{"label":"CD3E (via Mosunetuzumab)","text":"Open Targets has no association between CD3E and Hodgkins lymphoma.","source":{"label":"Open Targets: CD3E in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000198851/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"CD3G (via Mosunetuzumab)","text":"Open Targets has no association between CD3G and Hodgkins lymphoma.","source":{"label":"Open Targets: CD3G in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000160654/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"CD3D (via Mosunetuzumab)","text":"Evidence types in Hodgkins lymphoma: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: CD3D in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000167286/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"CD79B (via Polatuzumab vedotin)","text":"Evidence types in Hodgkins lymphoma: literature, somatic_mutation, clinical; literature listed separately from human genetics. Datasources: cancer_gene_census, clinical_precedence, europepmc.","source":{"label":"Open Targets: CD79B in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000007312/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"TUBB4B (via Polatuzumab vedotin)","text":"Evidence types in Hodgkins lymphoma: literature, clinical; literature listed separately from human genetics. Datasources: clinical_precedence, europepmc.","source":{"label":"Open Targets: TUBB4B in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000188229/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"TUBB1 (via Polatuzumab vedotin)","text":"Evidence types in Hodgkins lymphoma: clinical. Datasources: clinical_precedence.","source":{"label":"Open Targets: TUBB1 in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000101162/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}},{"label":"CD19 (via Tafasitamab)","text":"Evidence types in Hodgkins lymphoma: literature; literature listed separately from human genetics. Datasources: europepmc.","source":{"label":"Open Targets: CD19 in Hodgkins lymphoma","url":"https://platform.opentargets.org/evidence/ENSG00000177455/MONDO_0004952","date":"2026-11-11T22:11:08.513Z"}}],"pending":[{"what":"Normal-tissue expression in vital organs","source":"Human Protein Atlas (ticket 36)"},{"what":"Pan-essential in cell lines","source":"DepMap (ticket 36)"},{"what":"Approved drug on this target","source":"Drugs@FDA (ticket 30)"}]},{"n":2,"question":"Can the result be trusted?","flags":[{"id":"randomised","label":"Randomised","value":"yes","detail":"Randomised allocation","rule":"Registry allocation field","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},"context":[]},{"id":"small_denominator","label":"Small denominator","value":"no","detail":"36 planned; each patient moves a rate by 100 ÷ 36 = 2.8 points","rule":"Enrolment under 30; the arithmetic is shown, not a benchmark","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},"context":[]},{"id":"primary_os","label":"Primary endpoint is overall survival","value":"no","detail":"The best overall response rate (ORR).","rule":"A registered primary outcome measure names overall survival","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},"context":[{"figure":"Non-OS primary endpoint: odds ratio 2.79 for a positive phase 3","dataset":"Otsuka 2021, 400 phase 3 oncology trials","years":"to 2020","caveat":"Shown with the next figure: a surrogate is easier to hit, and often a weak guide to survival."},{"figure":"52% of surrogate-to-OS correlations are low","dataset":"Prasad 2015","years":"published to 2014","caveat":"Shown with the figure above."}]},{"id":"results_overdue","label":"Results overdue","value":"no","detail":"Primary completion expected 2027-08-19; not yet due","rule":"Primary completion (actual) more than 12 months ago and no results posted to the registry","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},"context":[]}],"facts":[],"pending":[{"what":"Treated and evaluable counts, assessor, confirmed response, follow-up and data cutoff","source":"Readout extraction (ticket 32)"},{"what":"Primary endpoint changed between registry versions","source":"Registry versions in the store (ticket 32)"}]},{"n":3,"question":"What must it beat?","flags":[],"facts":[],"pending":[{"what":"Control-arm result and approved therapies for the same segment, with label links","source":"Drugs@FDA, FDA labels and readouts (tickets 30, 32)"}]},{"n":4,"question":"Too crowded, or too late?","flags":[],"facts":[{"label":"Stopped on this target","text":"87 terminated, withdrawn or suspended trials of drugs against CD3E; 9 give no reason. Reasons are quoted as the registry gives them on the target page.","source":{"label":"CD3E: what already stopped","url":"/target/ENSG00000198851#stopped","date":"2026-11-11T22:11:08.529Z"}}],"pending":[{"what":"Programs on the target by phase and months behind the leader","source":"Programs and Drugs@FDA (ticket 33)"}]},{"n":5,"question":"Can it be approved, and stay approved?","flags":[{"id":"single_country","label":"Single-country","value":"yes","detail":"The only site is in United States","rule":"All listed sites are in one country; the share of US sites is shown","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636?tab=locations","date":"2026-11-11T22:11:08.513Z"},"context":[]},{"id":"eu_pip","label":"EU paediatric investigation plan","value":"yes","detail":"EMA/PE/0000181993 (mosunetuzumab, Treatment of mature B-cell neoplasms): PM: decision on the application for modification of an agreed PIP, 8 Nov 2024; EMEA-002499-PIP03-24 (tafasitamab, Treatment of mature B-cell neoplasms excluding diffuse large B-cell lymphoma): W: decision granting a waiver in all age groups for all conditions or indications, 13 Sept 2024; EMEA-002499-PIP02-19 (tafasitamab, Treatment of diffuse large B-cell lymphoma): W: decision granting a waiver in all age groups for all conditions or indications, 16 Aug 2019; EMEA-002255-PIP01-17 (polatuzumab vedotin, Treatment of mature B-cell neoplasms): W: decision granting a waiver in all age groups for all conditions or indications, 11 Apr 2018","rule":"An EMA PIP decision (agreement, modification or waiver) lists the drug as its active substance, exact name","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-paediatric_investigation_plans-output-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_orphan","label":"EU orphan designation","value":"yes","detail":"EU/3/25/3027 positive 26 Feb 2025: Treatment of follicular lymphoma; EU/3/21/2517 positive 12 Nov 2021: Treatment of follicular lymphoma; EU/3/18/2013 positive 16 Apr 2018: Treatment of diffuse large B-cell lymphoma; EU/3/14/1286 positive 4 Jul 2014: Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma; +1 more","rule":"An EU orphan designation lists the drug as its active substance (exact name) or belongs to a medicine that does; withdrawn and expired designations are listed with their status","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-orphan_designations-json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"eu_authorised","label":"Authorised in the EU","value":"yes","detail":"Polivy: authorised since 16 Jan 2020, orphan medicine; Lunsumio: authorised since 3 Jun 2022, orphan medicine, conditional; Minjuvi: authorised since 26 Aug 2021, orphan medicine, conditional","rule":"An EMA medicine record lists the drug as its active substance or INN, exact name; national-only authorisations are not in this file","source":{"label":"EMA data download (dated snapshot)","url":"https://www.ema.europa.eu/en/documents/report/medicines-output-medicines_json-report_en.json","date":"2026-11-11T09:12:26Z"},"context":[]},{"id":"fda_orphan","label":"FDA orphan designation","value":"not published","detail":"FDA's orphan designation database turns away automated requests, so this app does not read it; search it by hand at the link","rule":"Would be: an FDA orphan designation names the drug","source":{"label":"FDA orphan designations search","url":"https://www.accessdata.fda.gov/scripts/opdlisting/oopd/","date":""},"context":[]},{"id":"fda_ped_approval","label":"FDA pediatric oncology approval","value":"no","detail":"FDA's table lists no pediatric approval of Mosunetuzumab, Polatuzumab vedotin, Tafasitamab","rule":"FDA's Pediatric Oncology Drug Approvals table names the drug","source":{"label":"FDA Pediatric Oncology Drug Approvals (content current as of 2026-03-03)","url":"https://www.fda.gov/about-fda/oncology-center-excellence/pediatric-oncology-drug-approvals","date":"2026-11-11T22:11:08.539Z"},"context":[]},{"id":"studies_under_18","label":"Registered studies open to children","value":"yes","detail":"9 interventional studies of Mosunetuzumab, Polatuzumab vedotin, Tafasitamab include patients under 18; 8 are recruiting, not yet recruiting or active","rule":"The registry's age group includes Child (birth to 17 years), which also counts studies that set no minimum age","source":{"label":"ClinicalTrials.gov search","url":"https://clinicaltrials.gov/search?intr=%22Mosunetuzumab%22+OR+%22Polatuzumab+vedotin%22+OR+%22Tafasitamab%22&aggFilters=ages%3Achild%2CstudyType%3Aint","date":"2026-11-11T22:11:08.549Z"},"context":[]}],"facts":[{"label":"Caveat","text":"Site counts are not patients per country, and trials registered only outside ClinicalTrials.gov are not covered. Where the sites are is a fact about the record, not a judgement of its quality."},{"label":"Rare pediatric disease voucher","text":"FDA, content current as of 29 Apr 2026: “As of February 3, 2026, enactment of the Consolidated Appropriations Act, 2026, the rare pediatric disease PRV program will sunset after September 30, 2029. FDA may not award any PRVs under this program after September 30, 2029.” Voucher sale prices are not shown here; they appear only as company-reported news.","source":{"label":"FDA: Rare Pediatric Disease Designation and Priority Review Voucher Programs","url":"https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/rare-pediatric-disease-designation-and-priority-review-voucher-programs","date":"2026-11-11"}}],"pending":[{"what":"Precedent approvals for target, modality and endpoint; accelerated-approval status","source":"Drugs@FDA and FDA accelerated-approval tables (ticket 30)"}]},{"n":6,"question":"Can the sponsor finish?","flags":[],"facts":[{"label":"Sponsor","text":"M.D. Anderson Cancer Center (academic or other)","source":{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"}},{"label":"principal investigator","text":"Jason Westin, MD, MS, FACP, M.D. Anderson Cancer Center","source":{"label":"Person page","url":"/person/Jason%20Westin%2C%20MD%2C%20MS%2C%20FACP","date":"2026-11-11T22:11:08.513Z"}}],"pending":[{"what":"Filed cash, quarterly spend and the runway arithmetic","source":"SEC XBRL company facts (ticket 37)"},{"what":"Sponsor's completed vs stopped oncology trials and results-reporting record","source":"Registry, by company (ticket 37)"}]}],"limits":"Public records cannot show: sales forecasts; a probability of success for this asset; full deal terms and net prices; FDA designations and action dates before approval (shown only as company-reported); clinical holds unless the company disclosed them; manufacturing; patents on unapproved drugs; whether preclinical findings have been replicated.","sources":[{"label":"ClinicalTrials.gov NCT05615636","url":"https://clinicaltrials.gov/study/NCT05615636","date":"2026-11-11T22:11:08.513Z"},{"label":"Open Targets Platform","url":"https://platform.opentargets.org","date":"2026-11-11T22:11:08.513Z"},{"label":"FDA Pediatric Molecular Target List (Listed as February 2026 on the FDA Pediatric Oncology page; the file served is 9.7.22_the_relevant_molecular_target_list.xlsx, whose Summary of Changes sheet is headed 'SEPTEMBER 2022 UPDATE' (footnote date 2022-09-01))","url":"https://www.fda.gov/media/191157/download?attachment","date":"2026-11-11T07:05:03Z"}]},"source":"ClinicalTrials.gov + Open Targets","fetchedAt":"2026-11-11T22:11:08.511Z"}