Purpose Very few studies have demonstrated the rituximab biosimilarity in terms of efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity in patients with diffuse large B-cell lymphoma (DLBCL) in India. Therefore, we compared the efficacy, safety, pharmacokinetic, pharmacodynamic, and immunogenicity of our biosimilar rituximab with the reference rituximab (Ristova, Roche products [India] Pvt. Ltd) in patients with DLBCL in India. Methods A phase 3, randomized, assessor-blind, parallel-group, two-arm study was conducted across 28 sites in India. A total of 153 newly diagnosed DLBCL patients were randomized to receive either biosimilar rituximab or reference rituximab. The study drugs were administered at a dose of 375 mg/m 2 by intravenous infusion every 3 weeks for six cycles. The primary end point was objective response rate (ORR) at the end of Cycle 6. Secondary end points included: pharmacokinetic, pharmacodynamics, immunogenicity, and safety assessment. Results The ORR at the end of Cycle 6 was 82.14% in the biosimilar rituximab and 85.71% in the reference rituximab group. The risk difference (90% CIs) was – 3.57 (– 14.80, 7.66). It met the non-inferiority margin of – 20%. The pharmacokinetic and pharmacodynamic parameters were comparable between the two treatment groups. The incidence rate of immunogenicity was very low and similar in both the treatment groups. The safety profile of both the treatments was comparable with no major difference in terms of nature, frequency and severity of TEAEs. Conclusion The study demonstrated the biosimilarity between the biosimilar rituximab and the reference rituximab. Our biosimilar rituximab could add to the cost-effective treatment alternatives for patients with DLBCL in India. Supplementary Information The online version contains supplementary material available at 10.1007/s00280-023-04530-x.

Introduction Immune checkpoint inhibitors (ICIs) are rapidly being utilized as treatment option either alone or in combination with chemotherapy in most of the solid tumors. Objectives Our single-center retrospective study aimed to present our experience with the effectiveness and safety of these agents in Indian set of patients with various advanced solid tumors. Material and Methods Twenty-five adult patients with stage IV solid tumors of varying sites treated with ICIs at Aditya Birla Memorial Hospital, Pune, Maharashtra, India, between October 2017 and September 2020 were included in the study. Overall survival (OS), progression-free survival (PFS), overall response rate (ORR), disease control rate (DCR), and toxicity profiles were evaluated. All statistical calculations were performed using IBM SPSS version 25. Results Total of 25 patients (median age 61) was evaluated. Histological evaluation revealed adenocarcinoma (48%), squamous cell carcinoma (40%), and one each (4%) of others. Eastern Cooperative Oncology Group performance status score was I in 16 (64%) and II in 9 (36%) patients. Average of 10 cycles ICIs were received by each patient. Majority were males with 11 (44%) having some comorbidities. Lung (48%) was the most common primary followed by head and neck cancers (32%). Most (76%) were treated with nivolumab, followed by pembrolizumab (20%) while only one patient was given atezolizumab. Median follow-up was 18 months. Median OS was 24 months (95% confidence interval [CI]: 9–NA) and 2-year OS rate in the study was 38.4% (95% CI: 18.8–78.3), while median PFS was 9 months (95% CI: 6–NA) and 1-year PFS rate was 22.3% (95% CI: 9.7–51.2). One patient (4%) had complete response, 6 (24%) had partial response while 12 (48%) had stable disease response at first follow-up. Mean and median time to progression were 5.7 and 9 months, respectively. ORR was 28% (95% CI: 12.07–49.4) while the DCR was 76% (95% CI: 54.87–90.64). PS II patients were associated with significantly poor median OS and PFS. There was no significant difference in survival with respect to age, gender, site, histology, and comorbidities; however, 4/25 patients had undergone biomarker assessment and were associated with a trend toward better median PFS (8 vs. 11 months, hazard ratio 0.53, 95% CI: 0.12–2.34, p = 0.38). Two of 25 patients developed autoimmune conditions namely ophthalmoplegia and hypothyroidism each. Fatigue (36%) and nausea (12%) were the most common toxicities. Conclusion Real-world data from our study depicts our own experience with ICIs to suggest that these agents are well-tolerated and equally effective in Indian set of patients with advanced metastatic solid tumors. ICIs could be safely used even in patients with PS II and biomarker assessment in adjunction needs to be encouraged wherever feasible for better patient selection, prognostication, and clinical outcomes.

Introduction We document our data on the course of the coronavirus disease 2019 (COVID-19) infection in cancer patients in an attempt to help optimize their management in India and globally. Material and Methods Between February 2020 and January 2021, participating oncologists from Pune (members of the Oncology Group of Pune) documented effect of COVID-19 infection in their cancer patients. Binomial logistic regression analysis as well as correlation analysis was done using Pearson Chi-square test to determine significance of clinical factors. Results A total of 29 oncologists from 20 hospitals contributed their data involving 147 cancer patients who developed COVID-19 infections. COVID-19 infection resulted in higher deaths (likelihood ratio of 4.4) amongst patients with hematological malignancies (12/44 = 27.2%) as compared with those with solid tumors (13/90 = 14.4%, p = 0.030). Patients with uncontrolled or progressive cancer (11/34 = 32.4%) when they got infected with COVID-19 had higher mortality as compared with patients whose cancer was under control (14/113 = 12.4%; p = 0.020). Complication of thromboembolic episodes (seen in eight patients; 5.4% cases) was associated with higher risk (25.6 times) of death (five-eighths; 62.5%) as compared with those who did not develop it (20/139;14.4%; p <0.001). Discussion Patients with cancer should be advised to take strict precautions to reduce the risk of being infected with COVID-19. They should also be given priority for COVID-19 vaccination. If infected with COVID-19, patients with hematological malignancy and uncontrolled cancer are at higher risk of morbidity and mortality. When they are being treated (OPD or inpatient basis), additional precautions are necessary to ensure their exposure to potential COVID-19 virus is minimized. If they get infected with COVID-19, they should be given aggressive treatment to prevent complications, especially thromboembolic episodes. If they develop any thromboembolic complication, their risk of dying are significantly higher, and management should be modified accordingly.