Xatmep (methotrexate oral solution) / Azurity Pharma - LARVOL DELTA

SWOG-S1318: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2025 ➔ Jun 2026

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PDGFRA • PDGFRB

SWOG-S1318: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2024 ➔ Oct 2025

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PDGFRA • PDGFRB

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (clinicaltrials.gov) - P1/2 | N=15 | Recruiting | Sponsor: University of Chicago | Active, not recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (clinicaltrials.gov) - P1/2 | N=15 | Active, not recruiting | Sponsor: University of Chicago | Not yet recruiting ➔ Active, not recruiting | N=33 ➔ 15 | Initiation date: Apr 2025 ➔ Sep 2024

Enrollment change • Enrollment closed • Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (clinicaltrials.gov) - P1/2 | N=33 | Not yet recruiting | Sponsor: University of Chicago | Initiation date: Apr 2024 ➔ Apr 2025

Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants (clinicaltrials.gov) - P=N/A | N=39 | Completed | Sponsor: The Hospital for Sick Children | Recruiting ➔ Completed | N=304 ➔ 39

Enrollment change • Trial completion

A Study to Investigate LP-118, Ponatinib, Vincristine and Dexamethasone in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LBL) (clinicaltrials.gov) - P1/2 | N=33 | Not yet recruiting | Sponsor: University of Chicago

New P1/2 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

SWOG-S1318: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=53 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Oct 2023 ➔ Sep 2024

Trial completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PDGFRA • PDGFRB

High-Dose MTX Does Not Reduce CNS Relapse in Pediatric ALL (Medscape) - "'As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,' said briefing moderator Mikkael Sekeres....This is one of the abstracts that 'challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients, or at least no worse.'"

Media quote

Drug Concentrations in Breast Milk and Prediction of Blood Levels of the Breastfed Infants (clinicaltrials.gov) - P=N/A | N=304 | Recruiting | Sponsor: The Hospital for Sick Children

New trial

SWOG-S1318: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=57 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Jun 2023 ➔ Jun 2022

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PDGFRA • PDGFRB

SWOG-S1318: Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Cervical Cancer • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PDGFRA • PDGFRB

Expanded Table: Some conventional DMARDs for rheumatoid arthritis. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=58; Active, not recruiting; Sponsor: National Cancer Institute (NCI); Suspended ➔ Active, not recruiting

Clinical • Enrollment closed • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • MRI • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=44; Recruiting; Sponsor: National Cancer Institute (NCI); Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=44; Recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Jul 2019 ➔ Jul 2021

Clinical • P2 data • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=58; Recruiting; Sponsor: National Cancer Institute (NCI); N=44 ➔ 58

Clinical • Enrollment change • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=58; Suspended; Sponsor: National Cancer Institute (NCI); Recruiting ➔ Suspended

Clinical • Trial suspension • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: National Cancer Institute (NCI); Initiation date: Aug 2014 ➔ Jan 2015

Clinical • P2 data • Trial initiation date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=58; Recruiting; Sponsor: National Cancer Institute (NCI); Trial primary completion date: Jul 2021 ➔ Jun 2022

Clinical • Trial primary completion date • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Blinatumomab and Combination Chemotherapy or Dasatinib, Prednisone, and Blinatumomab in Treating Older Patients With Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2; N=50; Not yet recruiting; Sponsor: National Cancer Institute (NCI)

Clinical • New P2 trial • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia • ABL1 • BCR • CD4 • CSF1R • FGFR • PCR • PDGFRA • PDGFRB

Azurity garners OPDP untitled letter for problematic emails (Regulatory Affairs Professionals Society) - "Marketing Xatmep (methotrexate oral solution) to health care providers without giving a full presentation of the drug’s serious risks has garnered an untitled letter from the US Food and Drug Administration (FDA) for Azurity Pharmaceuticals...One statement which OPDP called misleading reads, 'I wanted to let you know that Xatmep® (methotrexate) oral solution is available for your patients with Acute Lymphoblastic Leukemia.'...'This claim is particularly concerning because it suggests the drug is approved for use in patients of all ages without consideration for the necessity of other treatments as part of a combination therapy,' wrote OPDP."

FDA event • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

Azurity’s Xatmep Promotional Email To Healthcare Professionals Gets Dinged By US FDA (Pink Sheet - Informa) - "...OPDP says that putting the methotrexate oral solution’s risk information below the signature block does not offer ‘prominence and readability’..."

FDA event • Acute Lymphocytic Leukemia • Hematological Malignancies • Oncology

Preventing Nephrotoxicity and Ototoxicity From Osteosarcoma Therapy (clinicaltrials.gov) - P2; N=13; Completed; Sponsor: Children's Hospital of Philadelphia; Active, not recruiting ➔ Completed

Clinical • Trial completion • KIM1