Chris Ryan

Articles

LSAM-PTX Demonstrates Disease Control, Safety in Locally Advanced Pancreatic Cancer

October 11th 2023

Treatment with intratumoral large surface area microparticle paclitaxel led to disease control and was well tolerated in patients with locally advanced pancreatic cancer.

First-Line TPST-1120 Plus Atezolizumab/Bevacizumab Improves Responses in Unresectable or Metastatic HCC

October 11th 2023

The addition of TPST-1120 to the combination of atezolizumab and bevacizumab led to improved responses vs atezolizumab plus bevacizumab alone in the first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma.

FDA Approves FoundationOne CDx Companion Diagnostic for Selpercatinib in RET+ Solid Tumors

October 10th 2023

The FDA has approved FoundationOne CDx for use as a companion diagnostic for selpercatinib, which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors harboring a RET gene fusion whose disease has progressed on or following prior systemic treatment, or who have no satisfactory alternative treatment options.

BXCL701 Plus Pembrolizumab Generates Positive OS Data in Small Cell Neuroendocrine mCRPC

October 10th 2023

Treatment with the combination of the investigational oral innate immune activator BXCL701 and pembrolizumab led to a median overall survival of 13.6 months in patients with small cell neuroendocrine carcinoma metastatic castration-resistant prostate cancer.

MRD Could Guide Venetoclax/Ibrutinib Duration in Previously Untreated, Intermediate-Risk CLL

October 8th 2023

The duration of treatment with the combination of venetoclax and ibrutinib could be guided by both toxicities and minimal residual disease kinetics in previously untreated patients with intermediate-risk chronic lymphocytic leukemia, according to interim results from the phase 2 ERADIC trial.

FDA Places Partial Clinical Hold on IND for Lacutamab in CTCL/PTCL

October 7th 2023

The FDA has placed a partial clinical hold on investigational new drug application for lacutamab, leading to a pause in new patient enrollment for the phase 2 TELLOMAK trial and a phase 1b trial, which are evaluating the agent in patients with advanced cutaneous T-cell lymphoma and peripheral T-cell lymphoma, respectively.

FDA Panel Votes Sufficient Evidence Available to Support EFS Benefit of Eflornithine in Pediatric High-Risk Neuroblastoma

October 6th 2023

In a 14-to-6 vote, the FDA’s Oncologic Drugs Advisory Committee voted sufficient evidence has been provided to demonstrate the event-free survival benefit of eflornithine to reduce the risk of relapse in pediatric patients with high-risk neuroblastoma.

FDA Panel Votes That Phase 3 PFS Data for Sotorasib in KRAS G12C+ Advanced NSCLC Cannot Be Reliably Interpreted

October 5th 2023

In a 10-to-2 vote, the FDA’s Oncologic Drugs Advisory Committee voted that the data for progression-free survival per blinded independent central review from the phase 3 CodeBreaK 200 trial evaluating sotorasib vs docetaxel for the treatment of patients with pretreated, locally advanced or metastatic KRAS G12C–mutated non–small cell lung cancer cannot be reliably interpreted.

First-Line Motixafortide Plus Cemiplimab/Chemotherapy Induces Responses in mPDAC

October 5th 2023

First-line treatment with the combination of motixafortide, cemiplimab-rwlc, gemcitabine, and nab-paclitaxel elicited responses in patients with metastatic pancreatic adenocarcinoma, according to initial data from the pilot portion of a phase 2 trial.

FDA Approves RAS Mutation Detection Kit as Companion Diagnostic for Panitumumab in mCRC

October 5th 2023

The FDA has approved the CRCdx® RAS Mutation Detection Kit as a companion diagnostic for panitumumab in the treatment of patients with metastatic colorectal cancer, according to an announcement from EntroGen.

Preoperative S-PBI Plus Endocrine Therapy is Safe, Produces Responses in Early-Stage ER+ Breast Cancer

October 4th 2023

Ablative preoperative stereotactic partial breast irradiation plus endocrine therapy was safe at a single fraction of 34 Gy and generated pathological complete responses and near complete responses in patients with early-stage, estrogen receptor-positive breast cancer.

FDA Grants Fast Track Designation to BI 764532 for ES-SCLC and Extrapulmonary NEC

October 3rd 2023

The FDA has granted a fast track designation to BI 764532 for the treatment of patients with extensive-stage small cell lung cancer that has progressed following at least 2 prior lines of treatment, and for patients with advanced or metastatic extrapulmonary neuroendocrine carcinoma that has progressed following at least 1 prior line of treatment.

PDS0101 Plus Pembrolizumab Elicits 74% 2-Year OS Rate in ICI-Naïve, HPV16+ HNSCC

October 3rd 2023

The addition of PDS0101 to pembrolizumab resulted in a 2-year overall survival rate of 74% in patients with unresectable, recurrent, or metastatic, HPV16-positive head and neck squamous cell carcinoma who were naïve to an immune checkpoint inhibitor.

FDA Grants Marketing Authorization to First DNA Test to Assess Genetic Predisposition to Select Cancers

October 2nd 2023

The FDA has granted de novo marketing authorization for the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test designed to detect genetic variants associated with an elevated risk of developing certain types of cancer.

Revumenib Meets CR/CRh End Point in KMT2A-Rearranged Relapsed/Refractory AML/ALL

October 2nd 2023

Treatment with the first-in-class menin inhibitor revumenib generated complete remissions or complete remissions with partial hematological recovery in adult and pediatric patients with relapsed/refractory acute myeloid leukemia or acute lymphoblastic leukemia harboring KMT2A rearrangements.

FDA Approves On-Body Injector for Self Administration of Pegcetacoplan for PNH

October 2nd 2023

The FDA has approved the Empaveli Injector designed to enhance the self administration of pegcetacoplan, which is approved for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria.

FDA Grants Priority Review to Odronextamab in Relapsed/Refractory Follicular Lymphoma or DLBCL

September 29th 2023

The FDA has granted priority review to the biologics license application seeking the approval of odronextamab for the treatment of adult patients with relapsed/refractory follicular lymphoma or relapsed/refractory diffuse large B-cell lymphoma who have progressed after at least 2 prior systemic therapies.

IMNN-001 Plus Neoadjuvant Chemotherapy Improves PFS in Advanced Ovarian Cancer

September 28th 2023

Treatment with the interleukin-12 gene-mediated immunotherapy IMNN-001 in combination with neoadjuvant platinum chemotherapy led to an improvement in progression-free survival compared with neoadjuvant chemotherapy alone in newly diagnosed patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer.

First-Line Amivantamab Plus Lazertinib Meets PFS End Point in EGFR+ NSCLC

September 28th 2023

First-line treatment with the combination of amivantamab and lazertinib resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared with osimertinib in patients with locally advanced or metastatic non–small cell lung cancer harboring EGFR mutations.

Isa-KRd Elicits MRD-Negative Remissions in Newly Diagnosed, High-Risk Myeloma

September 27th 2023

Treatment with the combination of isatuximab, carfilzomib, lenalidomide, and dexamethasone generated high rates of minimal residual disease negativity in patients with newly diagnosed, high-risk multiple myeloma, irrespective of transplant status.