{"id":768846,"date":"2023-07-11T07:54:03","date_gmt":"2023-07-11T11:54:03","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/adc-therapeutics-announces-voluntary-pause-of-enrollment-in-the-phase-2-lotis-9-clinical-trial-of-zynlonta-loncastuximab-tesirine-lpyl-and-rituximab-in-unfit-or-frail-previously-untreated-dlbc\/"},"modified":"2023-07-11T07:54:03","modified_gmt":"2023-07-11T11:54:03","slug":"adc-therapeutics-announces-voluntary-pause-of-enrollment-in-the-phase-2-lotis-9-clinical-trial-of-zynlonta-loncastuximab-tesirine-lpyl-and-rituximab-in-unfit-or-frail-previously-untreated-dlbc","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/adc-therapeutics-announces-voluntary-pause-of-enrollment-in-the-phase-2-lotis-9-clinical-trial-of-zynlonta-loncastuximab-tesirine-lpyl-and-rituximab-in-unfit-or-frail-previously-untreated-dlbc\/","title":{"rendered":"ADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients"},"content":{"rendered":"
\n

LAUSANNE, Switzerland, July 11, 2023 (GLOBE NEWSWIRE) — ADC Therapeutics SA (NYSE: ADCT) today announced a voluntary pause in the enrollment of new patients in the Phase 2 LOTIS-9 clinical trial (ClinicalTrials.gov Identifier: NCT05144009) evaluating ZYNLONTA\u00ae<\/sup> (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL).<\/p>\n

The voluntary action was taken by the Company after a recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events. These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs. As per investigator assessment, eleven of the twelve events (including six of the seven Grade 5 fatal events) were individually assessed as unlikely or unrelated to study drug. Four out of the five Grade 3 or Grade 4 events have since resolved and the patients have completed treatment per protocol. The cause of these events remains under further investigation.<\/p>\n

All patients with fatal events had one or more significant active underlying respiratory and\/or cardiac co-morbidities including severe chronic obstructive pulmonary disease (COPD), pulmonary edema, chronic bronchiectasis, idiopathic pulmonary\u00a0fibrosis and recent COVID-19 infection and all were greater than or equal to 80 years of age. The mean age was 82.7 years and the mean number of days from the last dose to death was 51 days, with a range of 19 to 86 days. It is important to note that all twelve of the patients with Grade 3-5 TEAEs in the LOTIS-9 study would have been excluded from the LOTIS-5 trial.<\/p>\n

The Company\u2019s decision to pause enrollment enables time to evaluate data around the TEAEs and determine next steps. The Company has notified all study investigators and regulatory authorities including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of the Company\u2019s decision to pause enrollment. The Company does not expect to report additional data from the trial by the end of the year.<\/p>\n

\u201cOur top priority is the safety of every patient who participates in our clinical trials,\u201d said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. \u201cGiven the aggregate of the respiratory-related events seen in the trial, we implemented a voluntary pause of enrollment to allow for a thorough investigation of the data set. This trial includes a very difficult-to-treat patient population with limited treatment options, and we will provide an update on next steps when available.\u201d<\/p>\n

\n LOTIS-9 Baseline Characteristics, Safety and Efficacy<\/strong> (as of May 10, 2023 data cutoff)<\/p>\n

The tables below illustrate preliminary data from the LOTIS-9 clinical trial with a data cut-off date of May 10, 2023. These data are reflective of the 30 patients who were enrolled by that point; since this time an additional 10 patients have enrolled and received treatment as part of the study.<\/p>\n

\n Table 1 \u2013 Baseline Characteristics<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
Variable<\/td>\nCohort A (Unfit)<\/td>\nCohort B (Frail or cardiac comorbidities)<\/td>\nTotal<\/td>\n<\/tr>\n
(N=13)\u00a0<\/td>\n(N=17)\u00a0<\/td>\n(N=30)\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Age (years)<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0n<\/td>\n13<\/td>\n17<\/td>\n30<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0Mean<\/td>\n83.4<\/td>\n82.2<\/td>\n82.7<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0std<\/td>\n2.69<\/td>\n6.26<\/td>\n5<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0Median<\/td>\n83<\/td>\n82<\/td>\n82<\/td>\n<\/tr>\n
\u00a0\u00a0\u00a0Min, Max<\/td>\n80, 89<\/td>\n72, 92<\/td>\n72, 92<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Sex, [n(%)]<\/td>\n<\/tr>\n
\u00a0 Female<\/td>\n3 (23.1)<\/td>\n7 (41.2)<\/td>\n10 (33.3)<\/td>\n<\/tr>\n
\u00a0 Male<\/td>\n10 (76.9)<\/td>\n10 (58.8)<\/td>\n20 (66.7)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Stage of Disease at Study Entry, n (%)<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0\u00a0Stage I<\/td>\n1 (7.7)<\/td>\n1 (5.9)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0\u00a0Stage II<\/td>\n3 (23.1)<\/td>\n4 (23.5)<\/td>\n7 (23.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Stage III<\/td>\n6 (46.2)<\/td>\n7 (41.2)<\/td>\n13 (43.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Stage IV<\/td>\n3 (23.1)<\/td>\n5 (29.4)<\/td>\n8 (26.7)<\/td>\n<\/tr>\n<\/table>\n

\n Table 2 \u2013 Treatment-Emergent Adverse Events with Fatal Outcome <\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u00a0<\/td>\nCohort A (Unfit)<\/td>\nCohort B (Frail or cardiac comorbidities)<\/td>\nTotal<\/td>\n<\/tr>\n
\u00a0<\/td>\n(N=13)<\/td>\n(N=17)<\/td>\n(N=30)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Patients with any fatal TEAE<\/td>\n3 (23.1)<\/td>\n3 (17.6)<\/td>\n6 (20.0)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Infections and infestations<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Pneumonia<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Respiratory, thoracic and mediastinal disorders<\/td>\n3 (23.1)<\/td>\n2 (11.8)<\/td>\n5 (16.7)<\/td>\n<\/tr>\n
\u00a0\u00a0Acute respiratory failure<\/td>\n1 (7.7)<\/td>\n0<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Chronic obstructive pulmonary disease<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Dyspnoea<\/td>\n1 (7.7)<\/td>\n0<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Hypoxia<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Respiratory failure<\/td>\n1 (7.7)<\/td>\n0<\/td>\n1 (3.3)<\/td>\n<\/tr>\n<\/table>\n

Since the data cut-off date of May 10, 2023, there has been one additional Grade 5 event for a total of seven Grade 5 events. Two out of seven patients died within 30 days from the last doses of study medication, the remaining 5 patients died more than 30 days after the last dose of study drug ranging from 41 to 86 days. Adverse events are coded using MedDRA version 24.1 and graded using CTCAE v5.0. Only treatment-emergent adverse events are summarized. For each system organ class and preferred term, patients are included only once.<\/p>\n

\n Table 3 \u2013 Treatment-Emergent Grade 3 or 4 Adverse Events \u2013 Cardiac, Infections \/ Infestations, Respiratory, Thoracic and Mediastinal Disorders and Others \u22655% Total\u00a0Occurrence* <\/strong><\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u00a0<\/td>\nCohort A (Unfit)<\/td>\nCohort B (Frail or cardiac comorbidities)<\/td>\nTotal<\/td>\n<\/tr>\n
\u00a0<\/td>\n(N=13)<\/td>\n(N=17)<\/td>\n(N=30)<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Patients with any grade >=3 TEAE<\/td>\n2 (15.4)<\/td>\n7 (41.2)<\/td>\n9 (30.0)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Cardiac disorders<\/td>\n1 (7.7)<\/td>\n1 (5.9)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Infections and infestations<\/td>\n0<\/td>\n2 (11.8)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0\u00a0Pneumonia<\/td>\n0<\/td>\n2 (11.8)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0\u00a0COVID-19 pneumonia<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Influenza<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Sepsis<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Respiratory, thoracic and mediastinal disorders<\/td>\n1 (7.7)<\/td>\n3 (17.6)<\/td>\n4 (13.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Acute respiratory failure<\/td>\n1 (7.7)<\/td>\n1 (5.9)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0\u00a0Pleural effusion<\/td>\n1 (7.7)<\/td>\n1 (5.9)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n
\u00a0\u00a0Dyspnoea<\/td>\n1 (7.7)<\/td>\n0<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0\u00a0Respiratory distress<\/td>\n0<\/td>\n1 (5.9)<\/td>\n1 (3.3)<\/td>\n<\/tr>\n
\u00a0<\/td>\n<\/tr>\n
Vascular disorders<\/td>\n1 (7.7)<\/td>\n1 (5.9)<\/td>\n2 (6.7)<\/td>\n<\/tr>\n<\/table>\n

Since the data cut-off date of May 10, 2023, there has been one additional Grade 3 or 4 cardiac event, one additional Grade 3 or 4 infection, and one additional Grade 3 or 4 respiratory event.<\/p>\n

*Numbers represent distinct TEAEs; patients may have experienced more than one event<\/p>\n

\n Table 4 \u2013 Overall Response Rate as Determined by the Investigator<\/strong>\n <\/p>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
\u00a0<\/td>\nCohort A (Unfit)<\/td>\nCohort B (Frail or cardiac comorbidities)<\/td>\nTotal<\/td>\n<\/tr>\n
(N=10)\u00a0<\/td>\n(N=7)\u00a0<\/td>\n(N=17)\u00a0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
Best Overall Response<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
\u00a0 Complete response<\/td>\n5 (50.0)<\/td>\n5 (71.4)<\/td>\n10 (58.8)<\/td>\n<\/tr>\n
\u00a0 Partial response<\/td>\n5 (50.0)<\/td>\n1 (14.3)<\/td>\n6 (35.3)<\/td>\n<\/tr>\n
\u00a0 Stable disease<\/td>\n0<\/td>\n1 (14.3)<\/td>\n1 (5.9)<\/td>\n<\/tr>\n
\u00a0 Not evaluable<\/td>\n0<\/td>\n0<\/td>\n0<\/td>\n<\/tr>\n
\u00a0 Progressive disease<\/td>\n0<\/td>\n0<\/td>\n0<\/td>\n<\/tr>\n
\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n\u00a0<\/td>\n<\/tr>\n
ORR (CR+PR), n (%)<\/td>\n10 (100)<\/td>\n6 (85.7)<\/td>\n16 (94.1)<\/td>\n<\/tr>\n
95% CI for ORR<\/td>\n(69.2, 100)<\/td>\n(42.1, 99.6)<\/td>\n(71.3, 99.9)<\/td>\n<\/tr>\n
95% CI for CR<\/td>\n(18.7, 81.3)<\/td>\n(29.0, 96.3)<\/td>\n(32.9, 81.6)<\/td>\n<\/tr>\n<\/table>\n

Best overall response (BOR) by investigator. Based on efficacy population, i.e., patients with baseline and at least one post-baseline disease assessment.
ORR=Overall Response Rate. CI=Confidence Interval.<\/p>\n

\n About ZYNLONTA<\/strong>
\n \u00ae<\/sup>
\n (loncastuximab tesirine-lpyl)<\/strong>\n <\/p>\n

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r\/r) large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double\/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval and in the European Union under conditional approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com<\/a>.<\/p>\n

\n About ADC Therapeutics<\/strong>\n <\/p>\n

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.<\/p>\n

ADC Therapeutics\u2019 CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.<\/p>\n

ADC Therapeutics is based in Lausanne (Biop\u00f4le), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https:\/\/www.adctherapeutics.com\/<\/a> and follow the company on Twitter<\/a> and LinkedIn<\/a>.<\/p>\n

ZYNLONTA\u00ae<\/sup> is a registered trademark of ADC Therapeutics SA.<\/p>\n

\n Forward-Looking Statements<\/strong>\n <\/p>\n

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements concerning the investigation of the causes of the pulmonary adverse events, anticipated communications and interactions with regulatory authorities and any actions taken by regulatory authorities or us relating to next steps for our LOTIS-9 or other clinical trials which could include protocol modifications, clinical suspensions or other actions; and statements relating to the development of products and product candidates, and the timing, conduct and results of clinical trials. In some cases you can identify forward-looking statements by terminology such as \u201cmay\u201d, \u201cwill\u201d, \u201cshould\u201d, \u201cwould\u201d, \u201cexpect\u201d, \u201cintend\u201d, \u201cplan\u201d, \u201canticipate\u201d, \u201cbelieve\u201d, \u201cestimate\u201d, \u201cpredict\u201d, \u201cpotential\u201d, \u201cseem\u201d, \u201cseek\u201d, \u201cfuture\u201d, \u201ccontinue\u201d, or \u201cappear\u201d or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: the nature, frequency and severity of adverse events; the ability to complete clinical trials on expected timelines, if at all; the outcome of clinical trials or the sufficiency of results from such clinical trials; the timing and results of the Company\u2019s or its partners\u2019 research projects or clinical trials including LOTIS 5, 7 and 9, ADCT 901, 601 and 602; and the timing and outcome of regulatory submissions and actions by the FDA or other regulatory agencies with respect to the Company\u2019s products or product candidates. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the \u201cRisk Factors\u201d section of the Company’s Annual Report on Form 20-F and in the Company’s other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.<\/p>\n

\n CONTACTS:<\/strong>\n <\/p>\n

\n Investors<\/strong>
\n
Eugenia Litz
ADC Therapeutics
Eugenia.Litz@adctherapeutics.com<\/a>
+44 7879 627205
+1 908-723-2350<\/p>\n

\n Media <\/strong>
\n
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com<\/a>
+1 862-926-9040<\/p>\n


\n
\n \n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

LAUSANNE, Switzerland, July 11, 2023 (GLOBE NEWSWIRE) — ADC Therapeutics SA (NYSE: ADCT) today announced a voluntary pause in the enrollment of new patients in the Phase 2 LOTIS-9 clinical trial (ClinicalTrials.gov Identifier: NCT05144009) evaluating ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The voluntary action was taken by the Company after a recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events. These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs. As per investigator assessment, eleven of the twelve … <\/p>\n

Continue reading “ADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-768846","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/adc-therapeutics-announces-voluntary-pause-of-enrollment-in-the-phase-2-lotis-9-clinical-trial-of-zynlonta-loncastuximab-tesirine-lpyl-and-rituximab-in-unfit-or-frail-previously-untreated-dlbc\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ADC Therapeutics Announces Voluntary Pause of Enrollment in the Phase 2 LOTIS-9 Clinical Trial of ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and Rituximab in Unfit or Frail Previously Untreated DLBCL Patients - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"LAUSANNE, Switzerland, July 11, 2023 (GLOBE NEWSWIRE) — ADC Therapeutics SA (NYSE: ADCT) today announced a voluntary pause in the enrollment of new patients in the Phase 2 LOTIS-9 clinical trial (ClinicalTrials.gov Identifier: NCT05144009) evaluating ZYNLONTA\u00ae (loncastuximab tesirine-lpyl) and rituximab (Lonca-R) in unfit or frail patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The voluntary action was taken by the Company after a recent review of aggregate data of the 40 patients enrolled in the trial and consultation with the Data Monitoring Committee (DMC) which signaled potentially excessive respiratory-related events. These respiratory-related treatment-emergent adverse events (TEAEs) included seven Grade 5 fatal events and five Grade 3 or Grade 4 respiratory-related TEAEs. 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