Pipeline Report: October 2022 | Articles

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FDA Grants Fast Track Designation to MT-101 for CD5+ Relapsed/Refractory PTCL

October 31st 2022

The FDA has granted a fast track designation to MT-101 for use as a potential therapeutic option in patients with relapsed or refractory, CD5-positive peripheral T-cell lymphoma.

FDA Grants Fast Track Designation to ITM-11 for Gastroenteropancreatic Neuroendocrine Tumors

October 28th 2022

The FDA has granted a fast track designation to 177Lu-edotreotide for use as a potential therapeutic option in patients with gastroenteropancreatic neuroendocrine tumors.

NVL-520 Demonstrates Preliminary Clinical Activity in ROS1-Positive NSCLC

October 28th 2022

The novel brain-penetrant ROS1-selective inhibitor NVL-520 elicited clinical activity and was well tolerated in heavily pretreated patients with ROS1 fusion–positive non–small cell lung cancer.

FDA Grants Fast Track Designation to TTI-101 for Advanced Hepatocellular Carcinoma

October 19th 2022

The FDA has granted a fast track designation to TTI-101 for the treatment of patients with relapsed/refractory locally advanced, unresectable, or metastatic hepatocellular carcinoma.

Salarius Pauses Phase 1/2 Trial Investigating Seclidemstat in Ewing Sarcoma and FET-Rearranged Sarcomas Following Death

October 19th 2022

Salarius Pharmaceuticals has voluntarily paused enrollment of new patients into a phase 1/2 trial investigating seclidemstat in patients with Ewing sarcoma, sarcomas with FET-family translocations, and myxoid liposarcoma due to the death of a patient.

Ubamatamab Monotherapy Elicits Responses in Heavily Pretreated Ovarian Cancer

October 18th 2022

Ubamatamab monotherapy produced early clinical activity and an acceptable risk/benefit profile in heavily pretreated patients with ovarian cancer.

177Lu-FAP-2286 Displays Preliminary Antitumor Activity in Advanced or Metastatic Solid Tumors

October 18th 2022

Lutetium-177-FAP-2286 produced preliminary evidence of antitumor activity with a manageable safety profile in patients with advanced or metastatic solid tumors, according to data from the phase 1/2 LuMIERE trial.

FDA Grants Orphan Drug Designation to ET140203 for Hepatoblastoma

October 17th 2022

The FDA has granted an orphan drug designation to ET140203 for the treatment of patients with hepatoblastoma.

GX-188E Plus Pembrolizumab Proves Safe, Effective in HPV16/18+ Recurrent or Metastatic Cervical Cancer

October 13th 2022

The therapeutic DNA vaccine, GX-188E, in combination with pembrolizumab produced encouraging responses in patients with human papillomavirus 16- or 18-positive, recurrent or metastatic cervical cancer who did not respond to standard-of-care treatment.

Sotorasib/BBP-398 Combo Snags FDA Fast Track Status for KRAS G12C–Mutated NSCLC

October 12th 2022

A combination regimen comprised of sotorasib and BBP-398 has been awarded a fast track designation from the FDA for use as a potential therapeutic option in adult patients with previously treated, KRAS G12C–mutated, metastatic non–small cell lung cancer.

Dostarlimab Elicits Survival Benefit in dMMR/MSI-H Advanced Endometrial Cancer

October 11th 2022

Single-agent dostarlimab-gxly produced progression-free survival and overall survival benefits in patients with advanced or recurrent mismatch repair–deficient/microsatellite instability–high endometrial cancer.

Gilteritinib Induces Encouraging Responses in Newly Diagnosed FLT3-Mutated AML

October 9th 2022

Gilteritinib, in combination with induction and consolidation chemotherapy, generated responses in patients with newly diagnosed acute myeloid leukemia, including those with FLT3 mutations, according to data from a phase 1 trial.

DZD1516 Demonstrates Safety, Early Activity in Heavily Pretreated Metastatic HER2+ Breast Cancer

October 6th 2022

DZD1516 monotherapy elicited early clinical activity and was found to be well tolerated in patients with HER2-positive metastatic breast cancer with or without brain metastases.

Ivosidenib/Venetoclax/Azacitidine Proves Tolerable, Strengthens Survival in AML

October 6th 2022

Ivosidenib plus venetoclax with or without azacitidine showed an expected and tolerable safety profile with durable responses and a prolonged survival rate across acute myeloid leukemia disease groups.

CUE-101 Gets Fast Tracked for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma

October 5th 2022

The FDA has granted a fast track designation to CUE-101 for use as a monotherapy and in combination with pembrolizumab in patients with human papillomavirus recurrent or metastatic head and neck squamous cell carcinoma.

FDA Awards Fast Track Designation to Eftilagimod Alpha Plus Pembrolizumab in Frontline NSCLC

October 5th 2022

The FDA has granted a fast track designation to eftilagimod alpha for use in combination with pembrolizumab as a frontline treatment for patients with stage IIIB/IV non–small cell lung cancer.

Sapanisertib Gets FDA Fast Track Status for Pretreated NRF2-Mutated Squamous NSCLC

October 4th 2022

The FDA has granted a fast track designation to sapanisertib as a potential therapeutic option in patients with unresected or metastatic squamous non–small cell lung cancer whose tumors harbor an NRF2 mutation and who have previously received platinum-based chemotherapy and immune checkpoint inhibition.

GPRC5D Antigen–Targeted CAR T-cell Therapy Induces Strong Response in Resistant Multiple Myeloma

October 3rd 2022

MCARH109, a CAR T-cell therapy targeting the “enigmatic” GPRC5D antigen, generated remissions in 70.6% of patients with relapsed/refractory multiple myeloma.