Scholars@Duke
Niharika Bansal Mettu

Niharika Bansal Mettu

Associate Professor of Medicine
Medicine, Medical Oncology
niharika.mettu@duke.edu
DUMC 3505, Durham, NC 27710
10 Bryan Searle Drive, Seeley G. Mudd Bldg, Room 433, Durham, NC 27710

Selected Publications

Open-label, dose-escalation FIGHT-101 study of pemigatinib combined with targeted therapy, chemotherapy, or immunotherapy in patients with advanced malignancies.

Journal Article ESMO Open · July 2024 BACKGROUND: Pemigatinib is an oral, potent, selective fibroblast growth factor receptor (FGFR) 1-3 inhibitor. FIGHT-101, a three-part, open-label, first-in-human, phase I/II study (NCT02393248), evaluated pemigatinib in patients with advanced solid tumors. ... Full text Link to item Cite

Data from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · March 12, 2024 <div>AbstractPurpose:<p>This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ ... Full text Cite

Data from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · March 12, 2024 <div>AbstractPurpose:<p>This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ ... Full text Cite

Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib.

Journal Article Clin Cancer Res · February 16, 2024 PURPOSE: Camonsertib is a highly selective and potent inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase. Dose-dependent anemia is a class-related on-target adverse event often requiring dose modifications. Individual patient risk factors for ... Full text Link to item Cite

Supplementary Fig. S3 from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <p>Supplementary Fig. S3. Summary statistics for the leave-one-out cross-validation of the nomogram.</p> ... Full text Cite

Supplementary Fig. S2 from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <p>Supplementary Fig. S2. Absolute monocyte and reticulocyte counts rebound quickly following dose holds.</p> ... Full text Cite

Data from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <div>AbstractPurpose:<p>Camonsertib is a highly selective and potent inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase. Dose-dependent anemia is a class-related on-target adverse event often requiring dose modifications. ... Full text Cite

Data from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <div>AbstractPurpose:<p>Camonsertib is a highly selective and potent inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase. Dose-dependent anemia is a class-related on-target adverse event often requiring dose modifications. ... Full text Cite

Supplementary Fig. S3 from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <p>Supplementary Fig. S3. Summary statistics for the leave-one-out cross-validation of the nomogram.</p> ... Full text Cite

Supplementary Fig. S2 from Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib

Other · February 16, 2024 <p>Supplementary Fig. S2. Absolute monocyte and reticulocyte counts rebound quickly following dose holds.</p> ... Full text Cite

Supplementary Table 10 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 10. Plasma proteins differentially expressed between cycle 1 day 1 and cycle 2 day 1 with (A) itacitinib plus pembrolizumab (Part 1b Group A-1), or (B) parsaclisib plus pembrolizumab treatment (Part 1b Group B-1/B-2, an ... Full text Cite

Supplementary Table 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 1. Summary of patient disposition (Part 1a Group A) (Full Analysis Set)</p> ... Full text Cite

Supplementary Table 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 1. Summary of patient disposition (Part 1a Group A) (Full Analysis Set)</p> ... Full text Cite

FIGURE 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>IHC analysis of paired screening and on-treatment (week 5–6) tumor biopsies, from patients receiving itacitinib or parsaclisib in combination with pembrolizumab. <b>A,</b> Study Part 1 (T-cell infiltration in combined tumor plu ... Full text Cite

TABLE 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of itacitinib and parsaclisib treatment-related TEAEs by MedDRA preferred term (≥5% of patients in the safety population)</p> ... Full text Cite

TABLE 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of itacitinib and parsaclisib treatment-related TEAEs by MedDRA preferred term (≥5% of patients in the safety population)</p> ... Full text Cite

Supplementary Table 3 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 3. Summary of patient disposition (Part 1b Expansion Group A-1/A-2) (Full Analysis Set)</p> ... Full text Cite

Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study.

Journal Article Cancer Res Commun · December 19, 2023 PURPOSE: This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ inhibitor) in combination with pem ... Full text Link to item Cite

FIGURE 3 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Heat map of plasma proteins significantly changed (log<sub>2</sub> fold change) between cycle 2 day 1 and cycle 4 or 6 day 1 in treatment groups itacitinib + pembrolizumab (Part 1b Group A-1/A-2) or parsaclisib + pembrolizumab ... Full text Cite

Supplementary Figure 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Figure 1. Singleplex and Multiplex immunohistochemistry examples.</p> ... Full text Cite

Supplementary Table 6 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of TEAEs by MedDRA preferred term [at least two patients (Part 1a Group A) or ≥10% of patients (Part 1a Group B, Part 1b, Part 2) in the safety population]</p> ... Full text Cite

Supplementary Table 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 2. Summary of patient disposition (Part 1a Group B) (Full Analysis Set)</p> ... Full text Cite

FIGURE 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Study design. Note: As of Protocol Amendment 8, enrollment was closed before reaching the planned number of patients. <sup>a</sup>Cohort 1 was initially evaluated. Cohort −1 was evaluated if the Cohort 1 dose proved intolerable ... Full text Cite

Supplementary Table 8 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 8. Summary of steady state itacitinib pharmacokinetic parameters (cycle 2 day 1).</p> ... Full text Cite

Supplementary Table 9 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 9. Summary of steady state parsaclisib pharmacokinetic parameters (cycle 2 day 1).</p> ... Full text Cite

Supplementary Table 4 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of patient disposition (Part 1b Expansion Group B-1/B-2) (Full Analysis Set).</p> ... Full text Cite

FIGURE 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Study design. Note: As of Protocol Amendment 8, enrollment was closed before reaching the planned number of patients. <sup>a</sup>Cohort 1 was initially evaluated. Cohort −1 was evaluated if the Cohort 1 dose proved intolerable ... Full text Cite

Supplementary Table 8 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 8. Summary of steady state itacitinib pharmacokinetic parameters (cycle 2 day 1).</p> ... Full text Cite

FIGURE 3 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Heat map of plasma proteins significantly changed (log<sub>2</sub> fold change) between cycle 2 day 1 and cycle 4 or 6 day 1 in treatment groups itacitinib + pembrolizumab (Part 1b Group A-1/A-2) or parsaclisib + pembrolizumab ... Full text Cite

FIGURE 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>IHC analysis of paired screening and on-treatment (week 5–6) tumor biopsies, from patients receiving itacitinib or parsaclisib in combination with pembrolizumab. <b>A,</b> Study Part 1 (T-cell infiltration in combined tumor plu ... Full text Cite

Supplementary Table 7 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 7. Serious TEAE ≥5% of patients by MedDRA preferred term (safety population).</p> ... Full text Cite

Data from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <div>AbstractPurpose:<p>This phase Ib open-label, multicenter, platform study (NCT02646748) explored safety, tolerability, and preliminary activity of itacitinib (Janus kinase 1 inhibitor) or parsaclisib (phosphatidylinositol 3-kinase δ ... Full text Cite

Supplementary Table 2 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 2. Summary of patient disposition (Part 1a Group B) (Full Analysis Set)</p> ... Full text Cite

Supplementary Table 4 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of patient disposition (Part 1b Expansion Group B-1/B-2) (Full Analysis Set).</p> ... Full text Cite

Supplementary Table 6 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Summary of TEAEs by MedDRA preferred term [at least two patients (Part 1a Group A) or ≥10% of patients (Part 1a Group B, Part 1b, Part 2) in the safety population]</p> ... Full text Cite

Supplementary Table 9 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 9. Summary of steady state parsaclisib pharmacokinetic parameters (cycle 2 day 1).</p> ... Full text Cite

Supplementary Figure 1 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Figure 1. Singleplex and Multiplex immunohistochemistry examples.</p> ... Full text Cite

Supplementary Table 7 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 7. Serious TEAE ≥5% of patients by MedDRA preferred term (safety population).</p> ... Full text Cite

Supplementary Table 3 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 3. Summary of patient disposition (Part 1b Expansion Group A-1/A-2) (Full Analysis Set)</p> ... Full text Cite

Supplementary Table 10 from Combination of Itacitinib or Parsaclisib with Pembrolizumab in Patients with Advanced Solid Tumors: A Phase I Study

Other · December 19, 2023 <p>Supplementary Table 10. Plasma proteins differentially expressed between cycle 1 day 1 and cycle 2 day 1 with (A) itacitinib plus pembrolizumab (Part 1b Group A-1), or (B) parsaclisib plus pembrolizumab treatment (Part 1b Group B-1/B-2, an ... Full text Cite

Exploratory analysis of mesenteric-portal axis CT radiomic features for survival prediction of patients with pancreatic ductal adenocarcinoma.

Journal Article Eur Radiol · August 2023 OBJECTIVE: To develop and evaluate task-based radiomic features extracted from the mesenteric-portal axis for prediction of survival and response to neoadjuvant therapy in patients with pancreatic ductal adenocarcinoma (PDAC). METHODS: Consecutive patients ... Full text Link to item Cite

Genomic analysis of early-stage lung cancer reveals a role for TP53 mutations in distant metastasis.

Journal Article Sci Rep · November 9, 2022 Patients with non-small cell lung cancer (NSCLC) who have distant metastases have a poor prognosis. To determine which genomic factors of the primary tumor are associated with metastasis, we analyzed data from 759 patients originally diagnosed with stage I ... Full text Link to item Cite

Phase II study of selumetinib, an orally active inhibitor of MEK1 and MEK2 kinases, in KRASG12R-mutant pancreatic ductal adenocarcinoma.

Journal Article Invest New Drugs · June 2021 Background Preclinical evidence has suggested that a subset of pancreatic cancers with the G12R mutational isoform of the KRAS oncogene is more sensitive to MAPK pathway blockade than pancreatic tumors with other KRAS isoforms. We conducted a biomarker-dri ... Full text Link to item Cite

Randomized phase II study of the Bruton tyrosine kinase inhibitor acalabrutinib, alone or with pembrolizumab in patients with advanced pancreatic cancer.

Journal Article J Immunother Cancer · February 2020 BACKGROUND: The immunosuppressive desmoplastic stroma of pancreatic cancer represents a major hurdle to developing an effective immune response. Preclinical studies in pancreatic cancer have demonstrated promising anti-tumor activity with Bruton tyrosine k ... Full text Link to item Cite

A phase I study of gemcitabine + dasatinib (gd) or gemcitabine + dasatinib + cetuximab (GDC) in refractory solid tumors.

Conference Cancer Chemother Pharmacol · June 2019 PURPOSE: This study was conducted to define the maximum tolerated dose (MTD), recommended phase two dose (RPTD), and toxicities of gemcitabine + dasatinib (GD) and gemcitabine + dasatinib + cetuximab (GDC) in advanced solid tumor patients. METHODS: This st ... Full text Link to item Cite

Clinical Insights Into the Biology and Treatment of Pancreatic Cancer.

Journal Article J Oncol Pract · January 2016 Pancreatic cancer is a devastating disease with a universally poor prognosis. In 2015, it is estimated that there will be 48,960 new cases of pancreatic cancer and that 40,560 people will die of the disease. The 5-year survival rate is 7.2% for all patient ... Full text Open Access Link to item Cite

Use of molecular biomarkers to inform adjuvant therapy for colon cancer.

Journal Article Oncology (Williston Park) · August 2013 The decision about who may derive benefit from adjuvant chemotherapy in colon cancer is often a difficult one for clinicians. While multiple trials have demonstrated that adjuvant chemotherapy reduces the risk of recurrence and improves overall survival in ... Link to item Cite

Use of molecular biomarkers to inform adjuvant therapy for colon cancer

Journal Article ONCOLOGY (United States) · January 1, 2013 The decision about who may derive benefit from adjuvant chemotherapy in colon cancer is often a difficult one for clinicians. While multiple trials have demonstrated that adjuvant chemotherapy reduces the risk of recurrence and improves overall survival in ... Cite

The nuclear receptor-coactivator interaction surface as a target for peptide antagonists of the peroxisome proliferator-activated receptors.

Journal Article Mol Endocrinol · October 2007 The peroxisome proliferator-activated receptors (PPARalpha, PPARdelta, and PPARgamma) constitute a family of nuclear receptors that regulates metabolic processes involved in lipid and glucose homeostasis. Although generally considered to function as ligand ... Full text Link to item Cite