Amna Sher
· Assistant Professor of MedicineStony Brook University · Hematology and Oncology
Active 1987–2025
About
Dr. Amna F Sher is a Hematology Oncology specialist based in Southampton, NY, affiliated with Stony Brook University Hospital, Stony Brook Children's Hospital, Stony Brook Southampton Hospital, and Stony Brook Eastern Long Island Hospital. She holds the academic title of Clinical Instructor in Medicine and practices at the Phillips Family Cancer Center and the Stony Brook Cancer Center. Dr. Sher completed her medical education at the University of Health Sciences, Lahore Fatima Jinnah Medical College for Women in 2005. She completed her residency in Internal Medicine at Stony Brook University Medical Center in 2011, followed by a research fellowship at Beth Israel Deaconess Medical Center in 2008, and a fellowship in Hematology/Oncology at Stony Brook University Medical Center in 2015. She is board certified in Hematology, Medical Oncology, and Internal Medicine by the American Board of Internal Medicine. Dr. Sher's expertise and practice focus on hematology and oncology, providing specialized care in these fields.
Research topics
- Oncology
- Medicine
- Internal medicine
- Gastroenterology
Selected publications
ImmunoDiff: A Diffusion Model for Immunotherapy Response Prediction in Lung Cancer
ArXiv.org · 2025-05-29
preprintOpen accessAccurately predicting immunotherapy response in Non-Small Cell Lung Cancer (NSCLC) remains a critical unmet need. Existing radiomics and deep learning-based predictive models rely primarily on pre-treatment imaging to predict categorical response outcomes, limiting their ability to capture the complex morphological and textural transformations induced by immunotherapy. This study introduces ImmunoDiff, an anatomy-aware diffusion model designed to synthesize post-treatment CT scans from baseline imaging while incorporating clinically relevant constraints. The proposed framework integrates anatomical priors, specifically lobar and vascular structures, to enhance fidelity in CT synthesis. Additionally, we introduce a novel cbi-Adapter, a conditioning module that ensures pairwise-consistent multimodal integration of imaging and clinical data embeddings, to refine the generative process. Additionally, a clinical variable conditioning mechanism is introduced, leveraging demographic data, blood-based biomarkers, and PD-L1 expression to refine the generative process. Evaluations on an in-house NSCLC cohort treated with immune checkpoint inhibitors demonstrate a 21.24% improvement in balanced accuracy for response prediction and a 0.03 increase in c-index for survival prediction. Code will be released soon.
Prognostic factors for survival in NSCLC treated with immunotherapy: An institutional analysis.
Journal of Clinical Oncology · 2024-06-01
articleSenior authore20591 Background: Immune check point inhibitors (ICIs) are the cornerstone of treatment for patients with advanced NSCLC. However, not all patients benefit from ICIs and some develop significant immune-mediated toxicities. There is limited data regarding prognostic factors in NSCLC patients treated with ICIs. Imaging features can complement clinical variables in predicting response to ICIs. This study aims to evaluate CEA, blood leukocyte markers, and novel CT-derived radiomic features as factors predictive of survival in this patient population. Methods: In this retrospective study, clinical data from patients with advanced stage NSCLC treated with ICIs at Stony Brook University Hospital from 2016 to 2021 were collected. Baseline and subsequent CEA (carcinoembryonic antigen), ANC (absolute neutrophil count), ALC (absolute lymphocyte count), NLR (neutrophil to lymphocyte ratio), AEC (absolute eosinophil count), and AMC (absolute monocyte count) were evaluated as independent prognostic factors. 3-D segmentation of ipsilateral lung lobe was obtained using U-Net and radiologist report of tumor location. 600 stable IBSI-standardized features were extracted from the region using PyRadiomics. The discriminative ability of clinical and image-derived variables was assessed using Kaplan-Meier survival and Cox proportional hazards regression analysis. Results: This study included 80 patients. Objective response rate (ORR) was 25.0% with 1-year OS of 58.0%. PD-L1 expression ≥ 50% was significantly associated with survival (p < 0.02). Decrease in CEA (p < 0.01) and 5% increase in AEC (p = 0.027) significantly correlated with survival. Age, sex, clinical stage, ANC, ALC, NLR, AMC did not significantly predict survival. Three image biomarkers that correlated with median enhancement of tissue on chest CT, and degree of tissue heterogeneity were significant predictors of mortality (p < 0.02). A multivariable model with clinical inputs outperformed one with radiomic features only (C-index 0.70 vs. 0.64). Clinical and radiomic inputs together performed well in predicting survival (C-index 0.76). Conclusions: Changes in CEA and AEC were the strongest predictors of survival in advanced NSCLC patients treated with ICIs. This study suggests that combined clinical and radiomic biomarkers (quantifying local lobar heterogeneity) can identify patients most likely to benefit from immunotherapy. [Table: see text]
Regular and Young Investigator Award Abstracts · 2024-11-01
articleOpen access<h3>Background</h3> Transforming growth factor-beta 1 isoform (TGFβ1) drives tumor immune escape by promoting an immunosuppressive pro-tumor microenvironment. Linavonkibart is a first-in-class fully human IgG4 context-independent anti-latent TGFβ1 monoclonal antibody. <h3>Methods</h3> Linavonkibart+pembrolizumab showed antitumor activity with no dose-limiting toxicity during dose escalation. In expansion cohorts, linavonkibart (1500mg q3w)+Pembrolizumab were administered in melanoma (MEL), urothelial carcinoma (UC), and non-small cell lung cancer (NSCLC) patients, who were non-responders to prior anti-PD1; and in clear cell renal cell carcinoma (ccRCC) and head and neck squamous cell carcinoma (HNSCC) patients, with disease progression on the most recent prior anti-PD1. Biomarker analyses include immunohistochemistry and flow cytometry. <h3>Results</h3> As of 11 Jun 2024, 78 patients (28.2% females, median age 65 years) were enrolled. Patients had received a median of 3 prior lines of therapies (range 1–9). All patients had a best response of SD or PD on prior anti-PD1 (except 1 HNSCC patient, who had PR). All patients had progressed on their most recent anti-PD1 (except 2 MEL patients). Treatment-related AEs (TRAE, ≥10%) of any grade were rash (33.3%), pruritus (26.9%), fatigue (21.8%) and diarrhea (15.4%). Rash (12.8%) was the only grade 3 TRAE (≥5%); only one grade 4 TRAE (dermatitis exfoliative generalized) occurred. There was no grade 5 TRAE. Treatment-related SAE (≥2% [2 pt]) was pemphigoid (2.6%). Efficacy results are presented in the table below. Tumor assessments were based on RECIST 1.1 criteria by PI. PFS rate (95% CI) for ccRCC patients at 6 months and 9 months were 44% (25.6, 61) and 28.6% (12.1, 47.5), respectively. (table 1). In ccRCC patients, baseline CD8+ T-cell infiltration status and baseline Treg levels correlated with positive clinical outcome: ORR increased to 33% (4/12) and 57.1% (4/7) for CD8+ infiltrated patients and elevated Treg patients, respectively. Across all cohorts, treatment with linavonkibart+Pembrolizumab shifted the microenvironment to more proinflammatory in responding patients. <h3>Conclusions</h3> Linavonkibart+Pembrolizumab treatment demonstrated promising efficacy in anti-PD1 resistant patients across multiple tumor types with a manageable safety profile. Baseline biomarker data from ccRCC patients showed clinical outcomes correlated with CD8+ infiltration and elevated Treg Levels, suggesting a potential patient selection strategy. These data support further investigation of linavonkibart. <h3>Trial Registration</h3> NCT04291079.
Regular and Young Investigator Award Abstracts · 2023-10-31
articleOpen access<h3>Background</h3> Transforming growth factor-beta (TGFβ), specifically the TGFβ1 isoform, drives tumor immune escape by promoting an immunosuppressive pro-tumor microenvironment, including reducing antigen presentation, as well as impairing T-cell infiltration and tumor-killing activity. SRK-181 is a fully human, selective, IgG4 monoclonal antibody targeting latent TGFβ1 under investigation as monotherapy or in combination with anti-PD-(L)1 therapy to overcome resistance to immune checkpoint inhibition. <h3>Methods</h3> DRAGON (NCT04291079) is an ongoing open-label, phase 1 study. Part A (3+3 dose escalation) evaluated SRK-181 in Part A1 and SRK-181+anti-PD-(L)1 in Part A2.<sup>1</sup> In Part B (expansion phase), SRK-181 (1500mg q3w)+pembrolizumab are administered in anti-PD-1 resistant patients with clear cell renal cell carcinoma (ccRCC), non-small cell lung cancer, melanoma, urothelial carcinoma, and head and neck cancer. Initial results in ccRCC cohort along with biomarkers assessing the tumor immune landscape are reported here. <h3>Results</h3> As of 26 May 2023, 20 anti-PD-1-refractory metastatic ccRCC patients were enrolled (2 in Part A2 and 18 in Part B), with median prior lines of therapies of 3 (range 1–6). All patients received at least one tyrosine kinase inhibitor and one anti-PD-1 therapy. The best responses on prior anti-PD-1 therapy were stable disease (SD) or disease progression (PD) and all patients progressed on prior anti-PD-1 therapy. Patients (4 females and 16 males) had a median age of 59 (range 43–80) years. The most common treatment-related AEs (TRAE,>10%) of any grade were pruritus (15%, n=3), rash maculo-papular (15%, n=3), and rash (10%, n=2). No grade 4 or 5 TRAEs were observed. Treatment-related SAEs include immune-mediated hepatitis, pemphigoid, and rash (n=1 each). Sixteen of the 20 patients are response evaluable since 4 ongoing patients are pending post-treatment radiographic evaluation. Four patients had confirmed partial response (PR) based on RECIST1.1 criteria by PI assessment (ORR=25%). The 4 PR patients, who had been previously treated with 2 to 5 prior lines of therapies, achieved tumor reduction of –50% to -84%, and remained on study for 5+ to 14+ months. Seven patients had SD (4 remain on study for 2+ to 8+ months). Biomarker data will be shared; initial results suggest that treatment decreased circulatory myeloid derived suppressor cell levels below baseline by Day 30 post-treatment. <h3>Conclusions</h3> As of 26 May 2023, combination treatment of SRK-181 and anti-PD-1 (pembrolizumab) was generally well tolerated with an ORR of 25% and clinical benefit rate of 69% in heavily pre-treated, anti-PD-1-refractory ccRCC patients. Enrollment is ongoing for all cohorts. <h3>Reference</h3> Yap T, Gainor J, McKean M<i>, et al.</i> 780 SRK-181, a latent TGFβ1 inhibitor: safety, efficacy, and biomarker results from the dose escalation portion of a phase I trial (DRAGON trial) in patients with advanced solid tumors. <i>Journal for ImmunoTherapy of Cancer</i> 2022;<b>10:</b>doi: 10.1136/jitc-2022-SITC2022.0780
Journal of Clinical Oncology · 2023-06-01 · 4 citations
articleTPS4176 Background: Gastric cancer (GC) remains the 4th leading cause of cancer death worldwide, accounting for about 7.7% of all cancer related mortality. Despite recent approval of nivolumab in combination with chemotherapy, the median survival of treatment naïve Gastric Cancer/gastroesophageal junction cancer (G/GEJ) cancer is only approximately 14 months, even in patients with high CPS PD-L1. Targeting claudin 18.2 (CLDN18.2) in combination with chemotherapy is a clinically validated approach for patients with CLDN18.2 expressing advanced G/GEJ cancer. TST001 is a humanized monoclonal antibody with improved affinity to human CLDN18.2 and enhanced antibody-dependent cellular cytotoxicity (ADCC). In pre-clinical studies, TST001 treatment upregulates PD-L1 expression on CLDN18.2-positive tumor cells. The in vivo analysis showed anti-tumor efficacy of TST001 combined with anti-PD-1 antibody and chemotherapy was superior to combination of anti-PD-1 antibody with chemotherapy or combination of TST001 with chemotherapy. Promising anti-tumor activities have been observed in patients with advanced G/GEJ cancer who have been treated with TST001 alone or in combination with chemotherapy, making the combination of TST001, nivolumab and chemotherapy attractive. Methods: This is a multi-cohort, open-label, multi-center phase I/II first in human (FIH) study of TST001 administered as single agent, in combination with nivolumab or standard of care in the treatment of patients with locally advanced or metastatic solid tumors. Primary endpoints include characterization of TST001 safety profile and the maximum tolerated dose / recommended phase 2 dose. Secondary endpoints include pharmacokinetics, immunogenicity, pharmacodynamics, and efficacy. The study includes two parts. Part A (completed) is a dose escalation of TST001 as a monotherapy. Part B (ongoing) consists of three independent cohorts: cohort A includes combination TST001 + nivolumab+ leucovorin calcium (folinic acid), fluorouracil, and oxaliplatin (mFOLFOX6) as 1 st line treatment for G/GEJ cancer; cohort B includes TST001 in combination with nivolumab in advanced pre-treated G/GEJ cancer; cohort C includes combination therapy of TST001, gemcitabine, and nanoparticle albumin-bound paclitaxel as 1 st line treatment for advanced/metastatic pancreatic cancer. Multiple doses and schedules will be assessed during Part B. Conclusions: Combination of TST001 with nivolumab and chemotherapy has the potential to improve the outcomes of patients with advanced or metastatic CLDN18.2 expressing G/GEJ cancer. Data from this trial will support the selection of the optimal dose and dose regimen of TST001 in these combinations. Enrollment in the trial is ongoing. Clinical trial information: NCT04396821 .
Journal of Clinical Oncology · 2023-06-01 · 4 citations
reviewe16556 Background: Enfortumab Vedotin (EV), a first-in-class antibody-drug conjugate directed against Nectin-4, is associated with peripheral sensory neuropathy (SN) in the treatment of advanced urothelial cancers. A systematic literature review and meta-analysis were conducted to assess the overall incidence and risk of SN in patients receiving EV. Methods: A systematic search through mid-2022 of PubMed, Cochrane Library, and recent ASCO annual and genitourinary meetings was conducted to identify relevant studies. Eligible studies were clinical trials of patients with urothelial cancer receiving single-drug EV at the standard dose with data on SN available. Incidence and relative risk (RR) of SN were calculated using both a fixed-effects and a random-effects model. Results: Of the 93 initial publications identified, there were 5 trials that met the eligibility criteria and included a total 996 patients with 630 patients receiving EV at the standard dose. The summary incidence of all-grade SN was 42.3% (95% CI: 38.5-46.2%) with the incidence of high-grade SN being 3.1% (95% CI: 1.9-4.9%). In comparison with standard chemotherapy, there was no significant difference for EV in all-grade SN (RR = 0.95, 95% CI: 0.77-1.18, p = 0.66) and high-grade SN (RR = 1.69, 95% CI: 0.40-7.21, p = 0.48). In some cases, SN also led to discontinuation of EV (4.4%, 95% CI: 2.1-6.7%). Conclusions: EV is associated with a substantial toxicity of peripheral sensory neuropathy, and its risk may be comparable to that of standard chemotherapy. Further studies are needed to assess and reduce the risk of severe neuropathy.
Regular and Young Investigator Award Abstracts · 2023-10-31 · 1 citations
articleOpen access<h3>Background</h3> SRK-181 is an investigational, fully human, IgG4 monoclonal antibody that selectively binds latent transforming growth factor-beta 1 (TGFβ1). TGFβ1 activation is associated with resistance to checkpoint inhibitors (CPI) in various cancers. A comprehensive biomarker strategy to validate SRK-181’s mechanism in patients and evaluate treatment response was based on our proof of concept for SRK-181 in preclinical models. The preclinical data revealed that combination of SRK-181 and anti-PD1 overcame immune exclusion in the tumor microenvironment leading to an influx of effector T cells into tumors which correlated with tumor regression and significant survival benefits.<sup>1</sup> <h3>Methods</h3> DRAGON (NCT04291079) is an ongoing open-label, phase 1 study. In Part B (expansion phase), SRK-181 (1500mg q3w or 1000mg q2w)+anti-PD-(L)1 are administered in anti-PD-(L)1 relapsed/refractory patients with clear cell renal cell carcinoma, non-small cell lung cancer, melanoma, urothelial carcinoma, or head and neck cancer. Biomarker assessment included: biopsies- immunohistochemistry; circulatory MDSC (Myeloid Derived Suppressor Cells) – flow cytometry. Biopsies were collected at baseline and post-treatment between Days 28 – 48. <h3>Results</h3> Exclusion of CD8+ T cells from the tumor has been proposed as a mechanism underlying immunosuppression contributing to CPI resistance in melanoma<sup>2</sup> and urothelial cancers.<sup>3</sup> As of June 21, three paired biopsies of sufficient quality were collected and stained for CD8. All 3 paired biopsies showed treatment with SRK-181 and anti-PD1 is associated with increased influx of CD8+ T cells into tumors. Treatment with SRK-181 and anti-PD1 decreased circulatory immunosuppressive MDSC levels. <h3>Conclusions</h3> These biomarker results from the DRAGON study are consistent with preclinical findings and provide proof of mechanism in the clinic that selectively targeting latent TGFb1 with SRK-181 can overcome the immune suppressive environment associated with CPI resistance. Part B enrollment is ongoing. <h3>References</h3> Martin CJ, <i>et al.</i><i> Selective inhibition of TGFbeta1 activation overcomes primary resistance to checkpoint blockade therapy by altering tumor immune landscape.</i><i> Sci Transl Med</i>, 2020;<b>12</b>(536). Hugo W, <i>et al.</i><i> Genomic and Transcriptomic Features of Response to Anti-PD-1 Therapy in Metastatic Melanoma.</i><i> Cell</i>, 2017;<b>168</b>(3):542. Mariathasan S, <i>et al.</i><i> TGFbeta attenuates tumour response to PD-L1 blockade by contributing to exclusion of T cells.</i><i> Nature</i>, 2018;<b>554</b>(7693):544–548.
Annals of Oncology · 2021-09-01 · 2 citations
articleSenior authorImproving tolerability of pembrolizumab with weight based dosing: A meta-analysis.
Journal of Clinical Oncology · 2021-05-20 · 1 citations
article2639 Background: Pembrolizumab, a PD-1 immune checkpoint inhibitor (ICI), has demonstrated significant clinical activity in various cancers. Despite a favorable toxicity profile, discontinuation due to adverse events including immune related adverse events (irAE) has been reported. We conducted a meta-analysis of published clinical trials to evaluate the tolerability of pembrolizumab in cancer patients. Methods: A systematic review was conducted of relevant studies from the databases of PubMed and abstracts presented at American Society of Clinical Oncology (ASCO) from June 2015 until September 2020. Eligible studies included prospective clinical trials that reported a discontinuation rate due to adverse effects. Incidence, relative risk and 95% confidence intervals (CI) were calculated by employing fixed or random effects models. Results: A total of 6,380 patients with a variety of hematologic and solid malignancies from 20 studies of pembrolizumab were included for analysis. The overall rate of pembrolizumab discontinuation due to adverse events was 8.2% (95% CI: 6.4-10.4%). The discontinuation rate of pembrolizumab was not significantly lower than the chemotherapy controls, with RR of 0.84 (95% CI: 0.58-1.12, p = 0.33). However, the discontinuation rate of pembrolizumab was significantly higher compared to placebo control with RR of 2.20 (95% CI: 1.36-3.54, p < 0.001), and significantly lower compared to ipilimumab with RR of 0.58 (95% CI: 0.34-0.99, p = 0.04) respectively. The discontinuation rate varied widely among different tumor types with the lowest rate of 0.8% (95% CI: 0.2-3%) in gastric cancer, and the highest of 13.5% (95% CI: 10.8-16.8%) in head and neck squamous cell carcinoma. Interestingly, the discontinuation rate varied with pembrolizumab dosing, with the fixed dosing of 200mg being 9.2% (95% CI: 6.9-12%) and the weight-based dosing being 6.5% (95% CI: 4.8-8.8%). The weight-based dosing was associated with a significantly lower discontinuation rate compared to controls with RR of 0.62 (95% CI: 0.47-0.81, p < 0.0001), while the fixed dosing had similar discontinuation rate with RR of 1.03 (95% CI: 0.89-1.20, p = 0.67). Conclusions: The tolerability of pembrolizumab may be comparable to chemotherapy in cancer patients and may vary with its dosing. Future studies are warranted to evaluate the impact of different dosing.
Journal of Clinical Oncology · 2021-02-20 · 1 citations
article1st authorCorrespondingTPS185 Background: LIV-1 is a transmembrane protein expressed in a variety of cancer types. SGN-LIV1A, or ladiratuzumab vedotin (LV), is a novel investigational humanized IgG1 antibody-drug conjugate (ADC) directed against LIV-1. LV mediates delivery of monomethyl auristatin E (MMAE), which drives antitumor activity through cytotoxic cell killing and induces immunogenic cell death. In a phase 1 study, LV was tolerable and active in heavily pretreated patients with metastatic breast cancer (Modi 2017). This study is currently evaluating the safety and efficacy of LV in different advanced solid tumors with various LIV-1 expression, including metastatic castration-resistant prostate cancer (mCRPC), advanced gastric and gastroesophageal junction (GEJ) adenocarcinoma, esophageal squamous cell carcinoma, small cell lung cancer (SCLC), non-small cell lung cancer (squamous and nonsquamous), head and neck squamous cell carcinoma, and melanoma. Methods: SGNLVA-005 (NCT04032704) is an open-label, phase 2 study evaluating LV monotherapy in patients with previously treated, locally advanced unresectable or metastatic advanced solid tumors, including mCRPC. Patients with mCRPC will receive LV administered as a 30 minute intravenous infusion (IV) at 1.25 mg/kg every 1 week. Up to 30 patients with mCRPC will be enrolled. Patients in the mCRPC cohort must have metastatic castration-resistant disease, have received no more than 1 prior line of androgen receptor-targeted therapy, have ≥28 days between androgen receptor-targeted therapy and start of study treatment, an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, and adequate organ function. In addition, mCRPC patients with measurable and non-measurable disease are eligible if the protocol-defined criteria are met. mCRPC patients must not have BRCA gene mutations, prior cytotoxic chemotherapy in the metastatic mCRPC setting, prior radioisotope therapy, or radiotherapy to ≥30% of bone marrow. Patients are not preselected based on tumor LIV-1 expression. Their tumor samples will be analyzed for correlation between LIV-1 expression and response. Safety and efficacy will be monitored throughout the study. Study objectives include objective tumor response rate per RECIST 1.1 and prostate-specific antigen (PSA) response rate per Prostate Cancer Clinical Trials Working Group 3 (both primary); safety and tolerability, disease control rate, duration of response, progression-free and overall survival, and pharmacokinetics and immunogenicity (all secondary); and pharmacodynamics. Study accrual is ongoing in the USA, Italy, South Korea, Taiwan, Australia, and the UK. Clinical trial information: NCT04032704.
Frequent coauthors
- 8 shared
Shenhong Wu
Stony Brook University
- 8 shared
Justine Y. Bruce
University of Wisconsin–Madison
- 6 shared
Y. Choi
- 5 shared
Nashat Gabrail
Gabrail Cancer Center
- 4 shared
Roger Keresztes
Stony Brook University Hospital
- 4 shared
Rachel E. Sanborn
Providence Portland Medical Center
- 4 shared
Randy F. Sweis
- 4 shared
Arielle Shebay Lee
HOPE Clinic
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