Lymphocytopenia

Cellectar Biosciences Reports High Rate of Complete Remission in Investigator Initiated Phase I Study of Iopofosine in Combination with External Beam Radiotherapy in Recurrent Head and Neck Cancer

Retrieved on: 
Monday, March 4, 2024

The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).

Key Points: 
  • The twelve patients treated for locoregionally recurrent head and neck squamous cell carcinoma previously received chemoradiation alone (42%), surgery (58%) or surgery combined with radiation or chemoradiation (92%).
  • The data were presented in a poster at the 2024 Multidisciplinary Head and Neck Cancers Symposium held February 29-March 2, 2024, in Phoenix, AZ.
  • Complete remission was achieved in 64% of patients, with an ORR of 73% (n=11).
  • Observed adverse events were consistent with the known toxicity profile of iopofosine I 131, with cytopenias being the most common with all patients recovering.

European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis

Retrieved on: 
Monday, February 19, 2024

Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.

Key Points: 
  • Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent.
  • “For the 2.6 million people in Europe living with UC, the unpredictable physical, mental, and emotional impacts of the condition can be debilitating.
  • This authorization follows the recommendation for approval by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2023.
  • Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of VELSIPITY.

European Commission Approves Pfizer’s ELREXFIO® for Relapsed and Refractory Multiple Myeloma

Retrieved on: 
Friday, December 8, 2023

Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).

Key Points: 
  • Pfizer Inc. (NYSE:PFE) today announced the European Commission (EC) has granted conditional marketing authorization for ELREXFIO® (elranatamab).
  • "More than 50,000 Europeans are diagnosed with multiple myeloma each year, and too often, they face relapse and treatment resistance,” said Chris Boshoff, Chief Oncology Research and Development Officer and Executive Vice President, Pfizer.
  • The conditional marketing authorization for ELREXFIO is valid in all 27 EU member states as well as Iceland, Liechtenstein, and Norway.
  • This authorization follows the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommendation for a conditional marketing authorization on October 12, 2023.

Human medicines European public assessment report (EPAR): Velsipity, Etrasimod, Status: Opinion

Retrieved on: 
Monday, December 18, 2023

Velsipity will be available as a 2 mg film-coated tablet.

Key Points: 
  • Velsipity will be available as a 2 mg film-coated tablet.
  • The active substance of Velsipity is etrasimod, a selective immunosuppressant (ATC code: L04AE05).
  • Treatment with Velsipity should be initiated under the supervision of a physician experienced in the management of ulcerative colitis.
  • Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Xilio Announces Initial Monotherapy Safety and Anti-Tumor Activity Data for XTX202, a Tumor-Activated, Engineered, Beta-Gamma IL-2, in Late Line Patients with Advanced Solid Tumors

Retrieved on: 
Friday, November 3, 2023

We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.

Key Points: 
  • We observed a disease control rate of 50% at higher doses (≥2.8 mg/kg) and 31% across all dose levels in a variety of advanced and IO refractory solid tumors, including cold tumors.
  • Eight (8) patients were treated in Phase 2 monotherapy at a dose level of 1.4 mg/kg Q3W.
  • As of the data cutoff date, 20 patients were continuing treatment with XTX202 across the Phase 1/2 trial.
  • Based on the initial monotherapy data for XTX202, Xilio also plans to explore opportunities for strategic partnerships to evaluate XTX202 as a combination therapy.

Indaptus Therapeutics to Present Positive Pharmacodynamic (PD) Immune and Pharmacokinetic (PK) Results with Patients from First Cohort of Ongoing Phase 1 Study of Decoy20 at Cancer Immunotherapy Meeting

Retrieved on: 
Tuesday, October 31, 2023

NEW YORK, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Indaptus Therapeutics, Inc. (Nasdaq: INDP) announces it will be presenting interim data from the first cohort of four patients in the Phase 1 INDP-D101 trial of its lead compound, Decoy20. The interim data, released today in abstract form, demonstrated that as of August 31, 2023, each of the first cohort participants experienced transient activation of biomarkers associated with innate and/or adaptive immune responses, and generally expected transient adverse events, both associated with predicted rapid clearance of Decoy20. The data in full will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) on November 4. The conference will be held from November 1-5, 2023 in San Diego.

Key Points: 
  • The data in full will be presented in a poster at the Society for Immunotherapy of Cancer (SITC) on November 4.
  • The conference will be held from November 1-5, 2023 in San Diego.
  • At one month following the single dose of Decoy20, all four of the first cohort patients had stable disease.
  • We are following these patients as well as working on enrolling the second cohort, which utilizes a lower dose.

New Phase 1 Dose Escalation Data Show Well-Tolerated Safety Profile and Anti-Tumor Activity for Aulos Bioscience’s AU-007 at Society for Immunotherapy of Cancer (SITC) Annual Meeting

Retrieved on: 
Friday, November 3, 2023

The data also demonstrate early evidence of anti-tumor activity in patients with several solid tumor cancer types.

Key Points: 
  • The data also demonstrate early evidence of anti-tumor activity in patients with several solid tumor cancer types.
  • “These encouraging new data support AU-007’s distinct advantages in the IL-2 class,” said Aron Knickerbocker, Aulos Bioscience’s chief executive officer .
  • At this point, we are observing the greatest anti-tumor activity in patients with tumors known to be sensitive to immune-modulating drugs.
  • These data support our decision to focus our Phase 2 expansion cohorts in melanoma, renal cell carcinoma and non-small cell lung cancer.

Ambrx Announces ARX517, a PSMA-Targeted ADC, Demonstrates a Promising 52% PSA50 (≥50% Reduction) and a Highly Differentiated Safety and PK Profile in Patients with mCRPC, who Progressed on Multiple FDA-Approved Treatments

Retrieved on: 
Monday, October 23, 2023

SAN DIEGO, Oct. 23, 2023 (GLOBE NEWSWIRE) -- Ambrx Biopharma, Inc., or Ambrx, (NASDAQ: AMAM), today announced that in biomarker unselected patients ARX517 monotherapy demonstrated a strong antibody-drug conjugate (ADC) safety profile at all doses tested with promising early efficacy signals that included PSA50 declines, ctDNA reductions, and RECIST v1.1 tumor response. The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 (NCT04662580).   Posters were made available as part of the 2023 European Society for Medical Oncology (ESMO) Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023, and are summarized below.

Key Points: 
  • The ESMO clinical posters present updated safety, efficacy and PK data from Ambrx’s on-going trial, APEX-01 ( NCT04662580 ).
  • APEX-01 is a Phase 1 / 2, first-in-human, open label dose escalation and dose expansion trial enrolling patients with metastatic castration-resistant prostate cancer (mCRPC).
  • APEX-01 opened for enrollment in July 2021 and is the only on-going clinical trial in the United States targeting PSMA with an ADC.
  • The two primary objectives of APEX-01 are to analyze the safety and tolerability of ARX517 and establish a recommended Phase 2 dose.

ENHERTU® Approved in the EU as the First HER2 Directed Therapy for Patients with HER2 Mutant Advanced Non-Small Cell Lung Cancer

Retrieved on: 
Monday, October 23, 2023

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).

Key Points: 
  • ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN).
  • In DESTINY-Lung02, ENHERTU (5.4 mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI]: 39.0-59.1) in patients with previously treated advanced or metastatic HER2 mutant NSCLC as assessed by blinded independent central review (BICR).
  • Grade 5 adverse reactions occurred in 1.4% of patients, including interstitial lung disease (1.0%).
  • Following approval in the EU, an amount of $75 million is due from AstraZeneca to Daiichi Sankyo as a milestone payment in HER2 mutant non-small cell lung cancer.