Лекарственно-индуцированное интерстициальное поражение легких у пациента с метастатической меланомой при использовании комбинации нурулимаб + пролголимаб

Drug-induced lung injury (DLI) comprises a wide variety of pathologies, each with a unique imaging pattern, so there are no characteristic imaging findings to establish diagnosis. When DLI is suspected, evaluation must exclude progression of underlying disease, infection, and mimicking diseases. Correct diagnosis requires integration of clinical information and radiologic, laboratory, and pathological findings when available. We describe the radiologic findings of DLI, the roles of the findings in the management of patients with DLI, and the limitations of radiologic diagnosis.

Background. In an era of breakthroughs in cancer immunotherapy, CheckMate 067 studies declared the combination of PD-1 and CTLA-4 inhibitors a new standard of care for patients with metastatic melanoma (MM). A significant limitation of the widespread use of the combination of ipilimumab and nivolumab in routine clinical practice is the high risk of severe immune-mediated adverse events. Prolgolimab and nurulimab are a combination of fixed doses of original monoclonal antibodies (manufactured by JSC "BIOCAD," Russia) to the PD-1 receptor (prolgolimab) and the CTLA-4 receptor (nurulimab) (3:1 ratio). This paper presents the results of an international, multicenter, double-blind, placebo-controlled, comparative, randomized, phase II OBERTON clinical study to investigate the efficacy and safety of nurulimab + prolgolimab combination therapy with continued prolgolimab therapy compared to prolgolimab alone as first-line therapy in patients with unresectable melanoma (uRM) or MM (NCT03913923). Materials and methods. The study included patients with uRM or MM who were not previously treated for metastatic disease. The patients were randomized into two groups (1:1). Patients in group 1 were treated with a nurulimab (1 mg/kg) and prolgolimab (3 mg/kg) combination at a dose of 0.2 mL/kg (equivalent to 1 mg/kg of nurulimab and 3 mg/kg of prolgolimab) once every 3 weeks during the first 4 blinded infusions. Patients in group 2 received prolgolimab monotherapy at a dose of 3 mg/kg once every 3 weeks during the first 4 blinded infusions. Starting from infusion 5, patients in both groups received open prolgolimab 1 mg/kg once every 2 weeks. The primary endpoint of the study was progression-free survival (PFS). The study is registered on ClinicalTrials.gov under the number NCT05732805 and is currently ongoing, but recruitment of new patients has been completed. Results. One hundred seventeen patients were randomized and received at least one dose of the study therapy. At a median follow-up of 16.79 months, the median PFS was 12.2 (4.9; not achieved) months in the nurulimab + prolgolimab group and 2.8 (1.5; 4.7) months in the prolgolimab monotherapy group (95% confidence interval 0.36-0.90, hazard ratio 0.57). PFS at 24 months was 41% in the nurulimab + prolgolimab group and 25.4% in the prolgolimab monotherapy group. In both groups, the therapy was well tolerated. Grade 3-4 immune-mediated adverse events were reported in 15.5% of patients who received nurulimab + prolgolimab, compared with 1.7% of those who received prolgolimab alone. The most frequent grade 3-4 treatment-related adverse events in both treatment groups were increased alanine aminotransferase and aspartate aminotransferase and asthenia. Overall, the safety profile was favorable, as expected for the class of immune checkpoint inhibitors, anti-CTLA-4, and anti-PD-1 monoclonal antibodies. Discussion. The results demonstrate a favorable safety profile in both the nurulimab + prolgolimab combination and prolgolimab monotherapy groups as the first-line treatment for uRM or MM. The assessment of the primary endpoint, PFS, showed the benefit of combination immunotherapy followed by switching to prolgolimab compared to prolgolimab alone. Conclusion. Combination immunotherapy with the CTLA-4 inhibitor nurulimab and the PD-1 inhibitor prolgolimab, available as a combination of solutions of two drugs in a single vial, with a further switch to monotherapy with prolgolimab, can fill an important niche in the treatment of patients with uRM or MM. Confirmation of the obtained data on the efficacy and safety of the combined regimen of nurulimab + prolgolimab in comparison with PD-1 inhibitor monotherapy is expected from the ongoing phase III BCD-217-2 OCTAVA study (NCT05732805).

Background: BCD-217-2/OCTAVA (NCT05732805) is an international, multi-center, randomized, double-blind, placebo-controlled phase III study conducted to access the efficacy and safety of prolgolimab+nurulimab (BCD-217) combination therapy with continued prolgolimab therapy compared to prolgolimab monotherapy as 1st line treatment for patients (pts) with unresectable or metastatic melanoma (un/mM). BCD-217 is a fixed-dose combination of nurulimab (aCTLA-4, 5 mg/ml) and prolgolimab (aPD-1, 15 mg/ml) was recently approved as the 1st line treatment for un/mM in Russia. Here we present the primary analysis of the study. Methods: Pts with unresectable or metastatic cutaneous melanoma (IIIC-IVM1a-c) with treatment- naïve for unresectable/metastatic disease were randomized in 2 treatment arms: combination drug containing nurulimab (1 mg/kg) and prolgolimab (3 mg/kg) at a dose of 0.2 ml/kg Q3W during the first four blinded infusions (nuru+prolgo arm) and prolgo arm received prolgolimab monotherapy at a dose of 3 mg/kg Q3W during the first four blinded infusions. Then both arms received prolgolimab maintenance up to two years. The primary endpoint of the study was progression-free survival (PFS). Results: 271 pts were randomized to nuru+prolgo (n=135) or prolgo monotherapy (n=136) arms. After the median of 15.8 mo follow-up the median PFS (mPFS) was 15.4 (10.3; ND) mo in the nuru+prolgo group and 10.8 (4.7; ND) mo in the prolgo monotherapy group (95% CI, HR 0.68 (0.482; 0.957), iRECIST). The mPFS benefit of nuru+prolgo arm compared to prolgo arm are maintained in RECIST 1.1 assessment: 9.9 mo vs 2.8 mo, respectively. ORR and DCR were also higher in NURU+PROLGO arm. mOS was not reached in both groups (95% CI, HR 0,88, (0.50; 1.55)). 12-mos OS was 84% in each arm. Grade 3-4 treatment-related AE were reported in 16.3% of pts in nuru+prolgo arm compared to 14.0% - prolgo arm. Immune-related AEs (irAE) of all grades were reported in 52.6% of cases in nuru+prolgo arm and 32.4% of cases - in prolgo arm (p 0.0007). Majority of them were mild. The proportion of gr.≥3 irAEs was 13.3% vs 5.9% in nuru+prolgo arm and prolgo arm, respectively (p 0.04). Treatment discontinuation due to AE was reported in 9.6% of cases for nuru+prolgo vs 4.4% of cases for prolgo arm. Conclusions: OCTAVA trial resuts demonstrated that the fixed-dose combination of nurulimab + prolgolimab is significantly more effective than aPD-1 monotherapy without a serious deterioration of the safety profile in patients with metastatic or unresectable cutaneous melanoma as 1st line therapy. Citation Format: Lev Demidov, Igor Samoylenko, Galina Kharkevich, Kristina Orlova, Vladimir Moiseenko, Igor Utyashev, Daniil Stroyakovskiy, Vadim Kozlov, Anastasia Mochalova, Svetlana Demidova, Marina Lyadova, Andrey Kutkovich, Pavel Skopin, Nadezhda Kovalenko, Sufia Safina, Vitaliy Volkov, Yulia Semiletova, Vera Vaschenko, Nikolaiy Kislov, Artem Poltoratsky, Irina Shumskaya, Sergey Kolomiets, Alexander Sobolev, Igor Belogortsev, Svetlana Odintsova, Sameer Rastogi, Timur Andabekov, Anastasia Zimina, Konstantin Penkov, Anna Semenova, Alexey Obukhov, Vasiliy Belyakovsky, Oleg Gladkov, Rakesh Neve, Natalia Falaleeva, Elena Poddubskaya, Amale Vaibhav, Dmitriy Kirtbaya, Yana Chapko, Maria Smagina, Irina Sorokina, Yulia Linkova, Arina Zinkina-Orikhan, Fedor Kriukov, Anton Lutsky, Evgenia Mikhailova. Proved clinical benefit of low-dose anti-CTLA4 + anti-PD-1 immunotherapy versus mono anti-PD-1 therapy in patients unresectable or metastatic melanoma: Phase III OCTAVA trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 653.

Background: Patients with advanced melanoma primarily refractory to single agent PD-1 blockade therapy have an option of receiving the CTLA-4 blocking antibody ipilimumab, but if ipilimumab should be given as a single agent or in combination with the anti-PD-1 nivolumab has not been established prospectively. Methods: Patients aged >18 with metastatic or unresectable melanoma without objective response to anti-PD-1 therapy given without CTLA-4 therapy were randomized 3:1 to receive either ipilimumab 3mg/kg + nivolumab 1mg/kg q3 wks x4 cycles followed by nivolumab 480mg q4wks (ipi/nivo) up to 2 years, or ipilimumab 3mg/kg q3weeks x4 cycles (ipi). Additional key eligibility criteria included ECOG Performance Statue (PS) 0-2, no active central nervous system metastases, autoimmune disease, or need for steroids at doses of >10 mg of prednisone or the equivalent. The primary endpoint was progression free survival (PFS). Disease assessments were performed every 12 weeks until progression. Secondary endpoints included overall survival (OS), objective response rate (ORR), and toxicity. All patients were to submit a fresh tumor biopsy and whole blood for correlative endpoints prior to cycle 1 and again at week 5. Results: 92 eligible patients were enrolled, 69 to ipi/nivo, 23 to ipi. Median age was 64 and 69 in the ipi/nivo and ipi arm respectively. 67% and 65% were male. 65% of patients in both arms had ECOG PS of 0. With a median follow up of 25.3 months, the hazard ratio (HR) for PFS was 0.63 (90% CI 0.41, 0.97) with a statistically significant 1-sided p-value of 0.04 favoring ipi/nivo. The 6-month PFS estimates were 34% (90% CI: 25%-44%) and 13% (4%-27%) for ipi/nivo and ipi respectively. ORR was 28% for ipi/nivo (95% CI 17%-40%) and 9% for ipi (95% CI: 3%-34%). With a median follow up of 24.4 months, 39/69 patients in the ipi/nivo arm and 12/23 patients in the ipi arm had died. 12-month OS was 63% (90% CI 52%-72%) in the ipi/nivo arm and 57% (38%-71%) months in the ipi arm. HR for OS was 0.94 (90% CI 0.54, 1.62) in favor of ipi/nivo with a p-value of 0.42. Adverse event rates were similar in both arms. One treatment related death was reported in the ipi/nivo arm due to disseminated intravascular coagulation and one treatment related death was reported in the ipi arm due to colonic perforation. Conclusions: This is the first prospective randomized study comparing ipi/nivo to ipi alone in patients with melanoma without response to anti-PD1 therapy. Ipi/nivo was associated with improved progression free survival as compared to ipi alone. The response rate of 28% to ipi/nivo as compared to 9% to ipi alone implies that patients who do not respond to PD-1 alone can be rescued with ipi/nivo. The toxicity of combination therapy was manageable. Ipi/nivo is an appropriate standard in patients with metastatic melanoma who do not respond to single-agent PD-1 therapy. ClinicalTrials.gov Identifier: NCT03033576 Funding: NIH/NCI grants: U10CA180888, U10CA180819, U10CA180821, U10CA180868; Other grants: SU2C-AACR-CT06-17 Citation Format: Ari M. Vanderwalde, James Moon, Kari Kendra, Nikhil I. Khushalani, Frances Collichio, Jeffrey A. Sosman, Alexandra Ikeguchi, Adrienne I. Victor, Thach-Giao Truong, Bartosz Chmielowski, David C. Portnoy, Michael C. Wu, Kenneth F. Grossmann, Antoni Ribas. S1616: Ipilimumab plus nivolumab versus ipilimumab alone in patients with metastatic or unresectable melanoma that did not respond to anti-PD-1 therapy [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT013.

The development of serious lung diseases, such as pulmonary fibrosis, is associated with several drugs. A recent study has shown that the epithelial-mesenchymal transition (EMT) plays an essential role in the development of pulmonary fibrosis. However, the mechanisms underlying drug-induced EMT in alveolar epithelial cells have not been characterized. The present study showed that methotrexate (MTX), a drug known to cause lung injury, induced EMT-like phenotypic changes in an A549 cell model of the alveolar epithelium. We also found that the transforming growth factor (TGF)-β1-mediated signaling pathway was associated with MTX-induced EMT. In addition, our results showed that certain secreted factors and microRNAs, a class of small noncoding RNAs, may be involved in MTX-induced EMT. The effects of COA-Cl, a novel synthetic small molecule, on TGF-β1-induced EMT were evaluated to determine the therapeutic potential of COA-Cl against drug-induced lung injury. COA-Cl significantly suppressed TGF-β1-induced EMT-like phenotypic changes, as evidenced by the inhibition of EMT-related transcription factors. Furthermore, MTX-induced EMT was completely suppressed by co-treatment with folic acid. Thus, these compounds may be promising therapeutic agents against drug-induced lung injury. In conclusion, the present study elucidated mechanisms underlying drug-induced EMT and highlighted a potential novel therapeutic approach to drug-induced lung diseases.

An optical pH-sensor integrated microfluidic platform multilayered with bacterial cellulose and gelatin methacrylate to mimic drug-induced lung injury

9538 Background: LBL007 is a novel, fully human IgG4 monoclonal antibody targeting human Lymphocyte-activation gene3 (LAG-3). Dual inhibition of anti-programmed cell death protein 1 (PD-1) and LAG-3 is anticipated to synergistically increase immune response against tumor growth. Here we report the preliminary safety and efficacy of LBL-007 in combination with Toripalimab (an anti-PD-1 antibody has approved for treatment of melanoma in China) in patients (pts) with unresectable or metastatic melanoma. Methods: Pts with unresectable or metastatic melanoma with or without prior anti-PD-(L)1 therapy were enrolled. This trial comprised 2 parts, namely part 1 (dose escalation), pts received LBL-007 (0.25/1/3/6 mg/kg) /Toripalimab (3 mg/kg) both i.v., Q2W; and part 2 (expansion), pts received LBL-007 (3/6 mg/kg)/Toripalimab (3 mg/kg) both i.v., Q2W. The primary objective was safety, the second objectives included pharmacokinetics, pharmacodynamics and efficacy (per RECIST 1.1). Results: By Jan 2022, 37 pts (15 [40.5%] male, median age 59 [range 31-74] years, 9 pts [24.3%] with baseline LDH elevation, 18 [48.6%] with acral, 12 [32.4%] mucosal, 5 [13.5%] nonacral cutaneous, 2 [5.4%] primary site unknown) were enrolled, with 17 in part 1 and 20 in part 2. No dose-limiting toxicity was observed in part 1, and the MTD was not reached. Of all 37 pts, the most common treatment-emergent adverse events (TEAEs) included anemia (24.3%), creatine phosphokinase elevation (24.3%), hypothyroidism (21.6%), and aspartate aminotransferase elevation (21.6%). For 32 radiologically evaluable pts, ORR was 12.5%, DCR was 53.1%. In a preplanned subtype-specific analysis in anti-PD-(L)1 treatment-naïve pts, ORR was 27.3 % vs. 0%, and DCR was 81.8% vs. 50.0% in acral and mucosal melanoma subtypes, respectively. For anti-PD-(L)1-resistant pts (n = 11), DCR was 18.2%. Conclusions: LBL007/Toripalimab combination is well tolerated and promising efficacy in pts with unresectable or metastatic melanoma, especially in the acral type without prior anti-PD-(L)1 therapy. Clinical trial information: NCT04640545.

IntroductionNew classes of drugs for metastatic or unresectable melanoma (MM) have shown improved survival in randomized trials (e.g., anti-CTLA-4, anti-PD-1, BRAF/MEK inhibitors). We sought to describe uptake of these new drugs and their impact on population-based survival outcomes of MM.
 Objectives and ApproachWe sought to describe uptake of these new drugs and their impact on population-based survival outcomes of MM. This was a retrospective, population-based cohort study of all treated MM in Ontario 2007-2015. Administrative data sources from the Institute for Clinical Evaluative Sciences (ICES) were utilized. Within ICES, cutaneous and non-cutaneous primaries were identified in the Ontario Cancer Registry. Administrative sources from Cancer Care Ontario, Ministry of Health and Long-Term Care, and Canadian Institute for Health Information identified patients treated with palliative systemic therapy, radiotherapy and metastatectomy. Temporal trends in utilization and survival were investigated. Survival by drug class was described.
 ResultsWe identified 2,793 MM patients. First treatment was systemic therapy (46%), radiotherapy (41%) or metastatectomy (14%). MM patient number increased from 270 in 2007 to 418 in 2015. Systemic treatment rose from 125 MM first treated in 2007 to 343 in 2015. New drug treatments increased from <6% of reported first-line regimens in 2007 to 82\% in 2015. 1-year and 2-year overall survival (OS) was 28% and 15% respectively for all MM in 2007-2009, rising to 46% and 35% for 2014-2015 (logrank p<0.001; adjusted hazard ratio (AHR) 0.56, 95% confidence interval (CI): (0.49,0.63)). Survival gains were largely in the subset treated primarily systemically, where new drugs were increasingly utilized (2-year OS 16% 2007-2009 vs. 44% 2014-2015 logrank p<0.001; AHR 0.46, 95% CI: (0.38,0.56)).
 Conclusion/ImplicationsUtilization of systemic therapy for MM has increased considerably in routine practice during 2007-2015; at least some of this increase relates to use of novel agents since 2011. In line with randomized trial findings, new drug adoption was associated with substantial increases in population-based MM survival.

Effective management of hepatic metastases from ocular and cutaneous melanoma remains a major therapeutic challenge. Treatment options include hepatic resection, hepatic intra-arterial (HIA) chemotherapy, chemoembolization, and hepatic perfusions. Evaluating the efficacy of these interventions is limited by the retrospective nature of most of the data, although controlled phase 3 studies are starting to emerge. Studies of hepatic resection are strongly suggestive of a survival benefit following surgery in selected patients. Effective systemic agents for metastatic cutaneous melanoma are available and supported by randomized controlled phase 3 trials. In contrast, no active systemic treatment has yet been identified for metastatic ocular melanoma. HIA and intravenous delivery of fotemustine have been compared in a randomized phase 3 trial in patients with unresectable metastases from melanoma, but no differences between the 2 approaches were observed. Hepatic arterial chemoembolization appears only to be moderately effective according to uncontrolled studies; targeting patients with less liver involvement may improve outcomes. A recent phase 3 study showed a significant improvement in hepatic progression-free survival with percutaneous hepatic perfusion compared with best alternative care in patients with metastatic melanoma; however, the overall survival analysis was confounded by crossover of control patients to active treatment. In conclusion, hepatic resection offers the possibility of long-term survival in carefully selected patients with liver-limited metastases from melanoma. In patients with unresectable cutaneous melanoma, effective systemic therapy is the best treatment option. For patients with unresectable ocular melanoma, regional treatments are likely to assume a greater role until effective systemic treatments are identified.

Detection of Mutant BRAF Alleles in the Plasma of Patients with Metastatic Melanoma

309 Background: Immunotherapy is being used increasingly to treat patients with locally-advanced unresectable or metastatic melanoma. To optimize patient care, members of the multidisciplinary healthcare team and their patients need up-to-date information about the latest therapies and the myriad factors that can influence outcomes. To assess patient-clinician alignment on perceptions of care, an educational initiative was designed for clinicians and patients/caregivers. Methods: A patient/caregiver educational activity was held in January 2023 in partnership with the Melanoma Research Foundation and remains on-demand at CancerCoachLive.com. An accredited clinician activity was held in February 2023 in collaboration with Partners for Advancing Clinical Education and remains on-demand at OMedLive.com. The Melanoma Action Coalition collaborated on both the patient and clinician activities. Behavioral assessment of preferences, attitudes, and barriers toward managing patients with melanoma were examined throughout the CME and patient/caregiver program. Data from these sessions were analyzed to determine behavioral and/or practice impact. Outcomes from the patient program were analyzed and provided as a supplemental resource for participants in the CME activity. Results: To date, 456 patients and 2,797 clinicians have participated in the educational initiative. Of the patient-reported experiences and preferences: 43% indicated they are under the care of a multidisciplinary team and only 42% were very satisfied with their current treatment regimen. The top two identified barriers in managing melanoma were anxiety about treatment efficacy (33%) and participating in normal activities (25%); these barriers were not aligned with those identified by clinicians. Upon evaluation of confidence in treatment decision-making; 70% of patients were not confident collaborating with their team while 74% of clinicians indicated low confidence in shared decision-making with their patients. At baseline, there was low awareness of safety and efficacy data regarding novel immunotherapy combinations and only 50% were likely to consider administering novel combinations to patients with unresectable locally advanced or metastatic melanoma. Clinicians additionally provided insight into barriers to patient enrollment in clinical trials with lack of trials at their institution being the greatest barrier (56%). Conclusions: Patient and clinician assessments provided an opportunity to determine misalignments in perceptions of barriers and insights into patient care experiences as well as clinician education needs. As novel immunotherapy combinations continue to become available for patients with unresectable melanoma, it is important to increase awareness of the clinical data and foster practical strategies to improve patient-centered care.

Background/AimNab-paclitaxel (Nab-PTX) has been widely used to treat several advanced cancers. Nab-PTX can cause drug-induced lung injury (DILI); however, its clinical and radiographic features have not been clarified. We aimed to assess the clinical characteristics of Nab-PTX-induced lung injury and identify its associated risk factors.Patients and MethodsWe retrospectively investigated 304 patients who received Nab-PTX at Chiba University Hospital between November 2010 and November 2017. We obtained information regarding the clinical course, laboratory findings, and chest computed tomography findings from their medical records.ResultsForty-one patients (13%) developed DILI. Grade 1 lung injury occurred in 27 patients (8.8%), grade 2, 8 patients (2.6%); grade 3, 3 patients (0.9%); grade 4, 1 (0.3%); and grade 5, 2 (0.6%). Multivariate analysis revealed that age >56 years (odds ratio [OR]: 3.0), pre-existing interstitial lung changes (OR: 3.2), and combined drugs with gemcitabine (OR: 2.7) were independent risk factors for DILI owing to Nab-PTX administration.ConclusionNab-PTX-induced lung injury is not rare; however, most cases are asymptomatic (grade 1). Older age, pre-existing interstitial lung changes, and combined drugs with gemcitabine could increase the incidence of Nab-PTX-induced lung injury; such patients should be treated with greater care.

Considerations regarding a network meta-analysis of targeted therapies for BRAF-mutant unresectable or metastatic melanoma

Background: Significant advancements, including development of immune checkpoint inhibitors and targeted therapies, have transformed outcomes in patients (pts) with unresectable or metastatic melanoma. However, pts who do not respond or who progress while receiving these regimens have limited options. Spartalizumab (PDR001) is a high-affinity, humanized monoclonal antibody blocking the programmed cell death 1 (PD-1) receptor. This study is evaluating combinations of spartalizumab with novel compounds to restore antitumor T-cell activity in pts with melanoma progressing after prior PD-1 blockade therapy. Methods: This randomized, open-label, 2-part, multicenter, open-platform, Phase II study (NCT03484923; PLATforM) will evaluate the safety and efficacy of spartalizumab combination treatment in pts with unresectable or metastatic melanoma progressing after prior anti-PD-1/L1 therapy and, if the tumor harbors a BRAF V600 mutation, a BRAF inhibitor. The primary endpoint is objective response rate per RECIST v1.1, with duration of response and assessment of paired tumor biopsies for biomarkers of antitumor T-cell activity as part of the secondary endpoints. Part 1, “selection”, will begin with 3 combination arms: (1) spartalizumab + LAG525 (LAG-3 antibody), (2) spartalizumab + capmatinib (c-MET inhibitor), and (3) spartalizumab + canakinumab (IL-1β antagonist). The PLATforM study will use an adaptive design during the selection part that allows for dropping arms for futility, adding new arms, and selecting 1 or multiple arms for further expansion. Bayesian methodology will be used with specific probability criteria for futility and efficacy assessments at each interim analysis. Pts (≈ 60-85) will be stratified by baseline lactate dehydrogenase level and randomized equally to all open arms during the selection part. Part 2, “expansion”, will further investigate the efficacy and safety of treatment combination(s) selected during part 1. The sample size for part 2 will be adaptive and based on predictive power calculations considering the results from part 1. Previously presented at ESMO 2018, FPN 1304TiP, Weber et al. Reused with permission. Citation Format: Caroline Robert, Reinhard Dummer, Ana Arance, Antoni Ribas, Jeffrey Weber, Georgina V. Long, John Haanen, Paul Nathan, Paolo A. Ascierto, Eduard Gasal, Anthony D9Amelio, Severine Bettinger, Aislyn D. Boran, Dirk Schadendorf. A randomized, open-label, open-platform, Phase II study evaluating the efficacy and safety of novel spartalizumab (PDR001) combinations in previously treated unresectable or metastatic melanoma (PLATforM) [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr CT120.

Introduction: Evaluation of the effectiveness of diagnostic computed tomography of the chest in differentiating between coronavirus 2019 (COVID-19) ground glass opacities and other reasons of ground glass opacities (GGO) not related to COVID-19. Place and Duration: In the department of Radiology, Miangul Abdul Haq Jahenzeb Kidney Hospital Swat for six-months duration from March 2021 to August 2021. Methods: 90 total covid-19 confirmed patients by RT-PCR having GGO (53 males and 37 females, with 47.20 ± 15.10 years mean age) and 110 patients (63 males and 47 males) who were confirmed GGO on chest CT but not due to Covid-19 were selected for the study. The experienced radiologists studied all chest CT scans after removing all descriptive information from the images. They tested negative or positive for COVID-19 and noted other features of CT of the lungs, including laterality, distribution pattern and lobe involvement. The laboratory results and clinical data were documented. Results: This study consisted of 90 COVID19 patients and 100 non-COVID-19 with ground glass opacities on CT chest. In terms of age; no statistically significant alteration was noted amid the 2 groups (p-value = 0.129). Non-COVID-19 cases with GGO; 6 patients have atypical bacterial pneumonia, 42 patients have GGO after viral pneumonia, 14 patients have interstitial pneumonia, 5 patients have PJP, eosinophilic pneumonia in 3 patients, 9 patients have hypersensitivity pneumonia, 6 patients have drug-induced lung injury, 5 patients have pulmonary alveolar hemorrhage and pulmonary edema in 11 patients (cardiogenic and noncardiogenic). Conclusion: Chest CT is rational for distinguishing ground glass opacities form COVID-19 and non-COVID-19 reasons, with less specificity for distinguishing COVID-19 from viral pneumonia and intermediate specificity for distinguishing COVID-19 from other reasons of ground glass opacities. Keywords: SARS-COV2, COVID-19, Diagnosis, Computed tomography and ground glass opacities.