Introduction: Pomalidomide is a third-generation immunomodulatory drug approved for relapsed and/or refractory Multiple Myeloma (RRMM). In the phase 3 OPTIMISMM trial, pomalidomide, bortezomib, and dexamethasone demonstrated superior efficacy in patients with RRMM. PRIME study (CTRI/2019/10/021618) is testing this combination in Newly Diagnosed Multiple Myeloma (NDMM) Aim: To determine safety of Pomalidomide in combination with Bortezomib and dexamethasone (VPD) in NDMM Study design: A prospective, single arm, phase II study from a tertiary center. Both transplant eligible and ineligible patients with NDMM aged between 18-70 years are being recruited in the study. Patients with Plasma cell leukemia, POEMS and amyloidosis were excluded. The regimen consists of weekly Bortezomib 1.3mg/sq.m (subcutaneous), Tab. Pomalidomide 2-4mg once daily for 21days, and Tab Dexamethasone 20mg twice weekly, with the cycle repeating every 28 days, 9-12 cycles. Here we report the adverse events (AE) by NCI CTCAE v5.0, upon recruiting 26 patients, as predetermined in the study. Results: Of the proposed 45-50 patients, 26 patients were enrolled in the study between April 2020 to May 2021 and 23 (88.4%) have completed 4 cycles of VPD. The median age is 55years (18-70), and gender ratio 1:1. At disease presentation, bone lesions were the commonest (96.2%, n=25), IMWG high risk cytogenetics were seen in 42.4% (n=11), RISS-2 in 69.3% (n=18), IgG kappa paraproteinemia in 54% (n=14) patients and ECOG performance score 2-3 in 57.6%(n=15). Ten (38.5%) patients have completed 9 cycles, and 3 underwent auto-transplant (between Cycle 4 & 6). Protocol adherence was 96.1% (25/26 patients). Table-1 shows drug-induced toxicity, hematological toxicities were the commonest. Two patients withdrew consent in view of bortezomib-induced peripheral neuropathy. Serious adverse events (SAE) were reported in 9 (34.6%) patients and were considered unrelated to the regimen by the safety committee (PSVT=1, Bony pain=2, dyspnea=1, pneumonia=1, constipation=1, diarrhea=1, hypotension=1) and one death due to SARS-CoV2 pneumonia. Treatment delays of 2 weeks in 4 patients (SARS-CoV2 = 3, Syncope = 1) After 4 cycles (n=23), 6 (26%) patients were in stringent Complete Response (sCR), 17(74%) in Very Good partial response (VGPR) and 13 (56.5%) are Measurable Residual Disease (MRD) negative. Of 10 patients who completed cycle 9, 9 were MRD negative and 1 showed disease progression. Conclusion: Safety data from the PRIME study demonstrates that VPD regimen has a favorable tolerance profile in patients with NDMM. Early efficacy signals are encouraging, and recruitment continues. Figure 1 Figure 1. Disclosures Radhakrishnan: Dr Reddy's Laboratories: Honoraria, Membership on an entity's Board of Directors or advisory committees; Emcure Pharmaceuticals: Research Funding; Intas Pharmaceuticals: Research Funding; Janssen India: Honoraria; NATCO Pharmaceuticals: Research Funding; Novartis India: Membership on an entity's Board of Directors or advisory committees; Roche India: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca India: Honoraria, Speakers Bureau; Bristol-Myers-Squibb India: Membership on an entity's Board of Directors or advisory committees, Research Funding; Cipla Pharmaceuticals India: Research Funding; Aurigene: Speakers Bureau. Garg: Dr Reddys Laboratories: Honoraria, Speakers Bureau. Nair: Dr Reddy's Laboratories: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Intas pharmaceuticals: Honoraria, Speakers Bureau; Mylan pharmaceuticals: Honoraria; Novartis India: Honoraria; Fresenius Kabi India: Honoraria; Cipla Pharmaceuticals: Honoraria, Speakers Bureau; Janssen India: Honoraria, Speakers Bureau. Chandy: Janssen: Honoraria; Pfizer: Honoraria; Intas Pharmaceuticals: Research Funding.

Polatuzumab vedotin is a novel immunotherapy antibody–drug conjugate targeting CD79b. It has been used in relapsed/refractory (R/R) large B-cell lymphomas since its FDA approval in 2019. Presently, this drug is unaffordable or unavailable for patients in Lower–Middle Income Countries (LMIC) like India. This is a retrospective study of adult (> 18 years) patients with R/R large B-cell lymphoma failing two prior lines of therapy, who received Polatuzumab based salvage therapy on a compassionate or named-patient access program. Between May 2019 and April 2022, 10 patients received Polatuzumab vedotin, and 9 were evaluable. The most common regimen used was Polatuzumab-Bendamustine-Rituximab. Out of 43 infusions administered, the adverse event profile was manageable [One grade-2 infusion reaction, 4 patients developed grade 3–4 hematological toxicity and none had grade 3–4 non-hematological toxicities]. Ten infusions were administered in the day care service. After a median of 4.5 cycles (range 1–8), 4 patients achieved CR, 2 had partial response (PR), and 3 had progressive disease (PD). With a median follow up of 491 days (range 8–1048 days), four patients are alive (three in CR and one in PR), three patients have died and three patients were lost to follow up. Early real-world experience from a LMIC setting demonstrates feasibility and a favourable safety profile of Polatuzumab vedotin based approach, along with encouraging response rates in a subset of patients.

INTRODUCTION: Literature on acute myeloid Leukemia (AML) from low and middle income countries (LMIC) like India indicate lower uptake of intensive treatment (29%) and higher induction mortality (25%) (Philip C, BJH 2015). This is attributable to delayed presentation, higher infection burden, multi-drug resistant organism (MDRO) infections, poor nutritional status, access to care, and high costs driven by 'out-of-pocket expenditures', among other reasons. AIM: To determine the clinical profile, cause and costs of care of patients who die during Induction therapy of newly diagnosed AML. METHODOLOGY: This is a retrospective chart review of newly diagnosed AML patients who died during Induction therapy. Induction mortality was defined as death within 60 days from the date of initiation of therapy for newly diagnosed AML. Secondary and therapy related AML were excluded from the study. Demographic and clinical profiling and analyses of the cause of death was undertaken. RESULTs: Between May 2011-Dec 2019, 825 adult patients were registered with newly diagnosed AML. 455 (55.2%) patients discontinued care primarily due to financial constraints, and 370 (44.8%) continued treatment here. Among these (n=370), 275 (74.3%) chose to receive standard or abbreviated intensive therapy (Group A), 58 (15.7%) chose disease control only with continuous less-intensive regimens like hypomethylating agents (Group B) and 37 (10%) chose palliation and best supportive care (Group C). Median age was 55y (20-84) overall, and 39.5y, 67.5y and 69y respectively in groups A, B and C. Females were 59% of the cohort. The overall induction mortality was 13.78% (n=51). Independently, induction mortality was 9.4% (26/275) in Group A, 24.13% (14/58) in Group B and 29.72% (11/37) in Group C, with a yearly trend suggesting a decrease in Group A (Fig 1) in the last 3 years. The most common cause of death was sepsis, 92.1% (n=47), with or without a bleeding episode. Isolated bleeding episodes were accountable for 4% (n=2) of overall deaths, and disease progression in the rest (n=2). Disease burden at presentation (% blasts in peripheral blood and marrow respectively, median values): 40% & 55% in Group A, 47% & 55% Group B, and 60% & 61% in group C. ELN 2017 risk grouping: 16% standard risk (n=8), 51% intermediate risk (n=26) & 33% high risk (n=17). 33% (n=17) had a lung infection at baseline and this was the commonest source of sepsis. Stool and throat surveillance cultures revealed MDRO (carbapenem resistant enterobacteriaceae) in 47% (n=15/32 tests) and 33% (n=7/21 tests) patients, respectively. 74.5% (n=38/51) developed blood culture positive infections during induction therapy. The median number of days to culture positivity was 11 days overall, 13 days in Group A (n=22), 3 in group B (n=13) and 1 day in Group C (n=3). The most common blood culture-detected organism was MDRO Carbapenem resistant Klebsiella (n=12). Imaging detected fungal infection was observed in 47% (n=24). The common antibiotic regimens included meropenem and colistin, with voriconazole being the most common antifungal used. The median ICU stay was 3.5 days (range of 0-24 days) in Group A and 1.5 days (range 0-13) in Group B. The median direct hospital costs in these patients were $6999 in Group A, $7923 in Group B and $2655 in Group C [per-capita GDP of India in 2019: $2099.6]. CONCLUSIONS: The induction mortality in AML varies with age and the intent of treatment. Younger patients undergoing intensive curative therapies have lesser induction mortality. Sepsis is the most common cause of induction deaths, primarily due to a high disease burden and higher infection burden at presentation, and the presence of MDRO bacteremia. Costs of care are very high and contribute to the high drop out rate from curative therapy of newly diagnosed AML. Figure 1 Figure 1. Disclosures Radhakrishnan: Novartis India: Membership on an entity's Board of Directors or advisory committees; NATCO Pharmaceuticals: Research Funding; Janssen India: Honoraria; Intas Pharmaceuticals: Research Funding; Bristol-Myers-Squibb India: Membership on an entity's Board of Directors or advisory committees, Research Funding; Roche India: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; AstraZeneca India: Honoraria, Speakers Bureau; Aurigene: Speakers Bureau; Dr Reddy's Laboratories: Honoraria, Membership on an entity's Board of Directors or advisory committees; Cipla Pharmaceuticals India: Research Funding; Emcure Pharmaceuticals: Research Funding. Garg: Dr Reddys Laboratories: Honoraria, Speakers Bureau. Nair: Intas pharmaceuticals: Honoraria, Speakers Bureau; Fresenius Kabi India: Honoraria; Janssen India: Honoraria, Speakers Bureau; Cipla Pharmaceuticals: Honoraria, Speakers Bureau; Novartis India: Honoraria; Dr Reddy's Laboratories: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; Mylan pharmaceuticals: Honoraria. Chandy: Intas Pharmaceuticals: Research Funding; Pfizer: Honoraria; Janssen: Honoraria.

Blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a rare hematopoietic malignancy with an aggressive behavior, seen commonly in the elderly age group and usually involves the skin. Evaluation, diagnosis, and treatment pose unique challenges with poor outcomes. We report a case of an 18-year-old female who presented with lymphadenopathy and bicytopenia. The diagnosis of BPDCN was an initial challenge. She thereafter received intensive chemotherapy followed by an allogenic partially mismatched sibling donor hematopoietic cell transplantation, only to relapse in a few months. Beginning from the diagnosis, the management of this rare disorder and its relapse until her last followup provided several learning opportunities.

Background: There is a lack of a uniform approach in the treatment of Classical Hodgkin lymphoma (CHL) in adolescents and young adults (AYA). Age cutoffs are arbitrary and based on institutional experience. Chemotherapy using ABVD (Adriamycin Bleomycin Vinblastine Dacarbazine) is the standard of care in most centers for the management of adult CHL. Children and adolescents have been managed with more chemo intense approaches like the EURONET protocol, with better Event-free survival (EFS) outcomes while reducing the need for radiation therapy (RT). There is a knowledge gap regarding the optimum treatment in the AYA group and this pertains to strategies to improve EFS while addressing increasing concerns of acute toxicities and long-term complications of therapy, RT especially. We share the retrospective experience of our center where young adults and adolescents received two different strategies based on an age cutoff alone, resulting in different outcomes. Methodology: A retrospective chart review of patients aged 10-30 years with newly diagnosed CHL between January 2014 to Dec, 2019 was undertaken. The demographic and clinical profile, treatment details, treatment related complications, RT requirement, and follow-up status for the entire cohort and for each of ABVD and EURONET treatment subsets were analysed. EURONET treatment strategy used 2 cycles of OEPA (Vincristine + Etoposide + Prednisone + Adriamycin) followed by 1-4 cycles of COPDAC (Cyclophosphamide + Vincristine + Dacarbazine + Prednisone), based on the risk level. ABVD protocol used 2 cycles of ABVD followed by 2 - 4 cycles of AVD/ABVD, or intensified chemotherapy based on the interim PET-CT scan response. RT was reserved for inadequate responders during interim assessment in both protocols. Events calculated were death, progression, refractory disease and relapse. Results: 470 patients with CHL were registered at our centre in the study period. 156 patients were in the 10-30yrs age group. 30 adolescents between ≥10 and <18 years of age (with median age 15.9 years) received the EURONET treatment strategy and 126 patients between ≥18 and ≤30 years (median age 22.7 years) received ABVD protocol. Median follow-up for the entire cohort was 28 months. The patient characteristics are shown in the Table 1. Advanced disease (Stage IIB-IV, and Bulky disease) was seen in 67.4% and 63.3% of patients treated with ABVD and EURONET treatment protocols, respectively. RT was administered in 37.7% of the patients on ABVD and 3.3 % patients on EURONET treatment protocol (Figure 1). 23% of the patients receiving the ABVD therapy had an event compared to 3.3% of the patients in the EURONET treatment group. The EURONET treatment group experienced more grade 3 or 4 acute toxicities (46.6%) when compared to ABVD (8%), the majority being neutropenic fever episodes. There was no treatment related mortality. The 3 year estimated EFS was 93.1% (Std.error=0.04) for the EURONET treated group whereas it was 71.9% (Std.error=0.044) for the ABVD group (Figure 2). Conclusions: This large single centre retrospective study of CHL in AYA patients shows better EFS and lesser requirement of RT in the EURONET treated group, at the cost of increased acute hematological toxicity. Though an age-matched direct comparison between the treatment groups was not feasible, this study suggests that chemotherapy intensification in the AYA group is possible and may potentially improve EFS while reducing the need for Radiotherapy. Disclosures Radhakrishnan: Pfizer, India: Honoraria, Speakers Bureau; Roche, India: Research Funding; Bristol Myers Squibb, India: Research Funding; Astra Zeneca, India: Honoraria, Speakers Bureau; Novartis, India: Honoraria, Speakers Bureau; NATCO pharmaceuticals: Research Funding; Emcure pharmaceuticals: Research Funding, Speakers Bureau; Dr. Reddys Laboratories: Speakers Bureau; Aurigene: Honoraria; Cipla: Honoraria, Research Funding, Speakers Bureau; Intas: Research Funding, Speakers Bureau. Chandy:NATCO Pharmaceuticals: Research Funding; Intas Pharmaceuticals: Research Funding. Nair:Intas Pharmaceuticals: Research Funding, Speakers Bureau; Cipla: Speakers Bureau; Dr Reddys Laboratories: Honoraria, Research Funding, Speakers Bureau.

Background and Objectives:Cancer associated malnutrition and cachexia is an important determinant of the patient's short and long term outcomes. This prospective study was conducted to determine the association between cachexia at diagnosis and overall survival of patients with aggressive B-cell non-Hodgkin's Lymphoma (ABNHL) Methods:This investigator initiated single centre prospective observational study was conducted at the Tata Medical Center, Kolkata, India between Jan 2015 and Mar 2019 after IRB approval. Patients diagnosed with ABNHL receiving standard of care chemo-immunotherapy were eligible. This study was supported by an educational research grant from Baxter to our institution. All patients who consented to participate were screened for cachexia at entry using a modified Subjective Global Assessment (SGA) tool (1). Baseline clinical factors of prognostic importance including stage, IPI score, etc. were recorded. All statistical analysis was carried out using EpiInfo-ver.7 software. Results:239 patients diagnosed with high grade B-NHL were recruited. The study group included 89 women and 150 men, and 77 (32.1%) were older than 65 years. 130 (54.3%) patients received private care. 88(36.8%) had IPI stage high-intermediate plus high grade; 136 (56.9%) had Ann Arbor stage III plus IV disease; 40 (16.7%) had extra-nodal NHL; 96 (40.1%) had weight loss and 107(44.7%) had reduced food intake. Cachexia scores estimated by the modified SGA tool was SGA-A in 101, SGA-B in 120 and SGA-C in 18 patients. Only 37 (15.4%) had been subjected to screening for malnutrition prior to cancer treatment. 44 (20.5%) patients experienced neutropenic sepsis during treatment. At a median follow up of 457 days, 69% achieved complete remission at the end of initial therapy, 50 (20.9%) patients died during the study period. In univariate analysis, SGA, IPI, Stage and age groups were statistically significant prognostic markers. The 2-year actuarial survival of all patients adjusted for SGA, IPI and Stage was 72%. The two-year actuarial survival in the SGA-A, SGA-B, and SGA-C groups were respectively 80%, 68% and 45% (p<0.001). In a multivariate analysis using cox proportional hazards method the hazard ratio for SGA B was 1.67 (0.94-2.97), and SGA-C was 3.65, after adjusting for IPI and stage groups (p=0.0137).The follow up is continuing and final multivariate analysis will be done when sufficient events have occurred. Conclusions:Cachexia at diagnosis is an important independent prognostic biomarker in patients with ABNHL. The role of routine screening for cachexia before initiating treatments and providing individualized medical nutrition therapy along with physical therapy during chemotherapy to prevent worsening of cachexia and improve survival needs evaluation. References: 1.Shirodkar M etal, Indian J Gastroenterol.2005; 24:246-50 Figure Disclosures Patra: Baxter: Research Funding. Mallath:Otsuka Pharmaceuticals: Consultancy, Membership on an entity's Board of Directors or advisory committees; Pfizer: Speakers Bureau; GlaxoSmithKline: Research Funding; Baxter: Research Funding; Otsuka Pharmaceuticals: Honoraria; Bristol-Myers Squibb: Honoraria; Bayer-Zydus Pharma: Honoraria; Sayre-Therapeutics: Honoraria.