Pipeline Report: September 2022 | Articles

FDA Grants Orphan Drug Designation to SynKIR-110 for Mesothelin-Expressing Mesothelioma

September 28th 2022

The FDA has granted an orphan drug designation to SynKIR-110, a first-in-class KIR-CAR T-cell immunotherapy candidate, for the treatment of patients with mesothelin-expressing mesothelioma.

Gavo-cel Elicits Clinical Benefit in Solid Tumors, Including Ovarian Cancer and Mesothelioma

September 28th 2022

Gavocabtagene autoleucel demonstrated positive topline results from the phase 1 portion of a phase 1/2 trial in patients with mesothelin-expressing solid tumors.

FDA Grants Fast Track Designation to KIN-2787 for Select Stage IIB to IV Malignant Melanoma

September 26th 2022

The FDA has granted a fast track designation to KIN-2787 for use as a potential therapeutic option in patients with BRAF class II or III alteration–positive and/or NRAS mutation–positive, metastatic or unresectable, stage IIB to IV malignant melanoma.

TAC01-HER2 Showcases Early Clinical Activity in HER2-Overexpressed Solid Tumors

September 25th 2022

TAC01-HER2 demonstrated early signals of clinical activity with a tolerable safety profile in patients with HER2-overexpressed solid tumors.

FDA Grants Fast Track Designation to Ficlatuzumab for Relapsed or Recurrent HNSCC

September 23rd 2022

The FDA has granted a fast track designation to ficlatuzumab for the treatment of patients with relapsed or recurrent head and neck squamous cell carcinoma.

Dostarlimab Provides Survival Benefits in dMMR Endometrial Cancer and Other Solid Tumors

September 22nd 2022

Single-agent dostarlimab showcased durable antitumor activity in patients with mismatch repair–deficient endometrial cancer and other solid tumors, with landmark estimates at various time points underscoring stable progression-free survival benefits in responders.

Fianlimab Plus Cemiplimab Generates Meaningful Responses in Anti–PD-1/PD-L1–Naïve Advanced Melanoma

September 21st 2022

The combination of fianlimab and cemiplimab demonstrated clinically meaningful activity in patients with advanced melanoma who were naïve to anti–PD-1/PD-L1 therapy.

Zanidatamab Zovodotin Showcases Promising Safety, Activity in HER2+ Solid Cancers

September 21st 2022

Zanidatamab zovodotin was found to produce encouraging responses and to have a manageable toxicity profile when used as a monotherapy in heavily pretreated patients with HER2-positive solid cancers.

FDA Grants Orphan Drug Designation to ATG-101 for Pancreatic Cancer

September 19th 2022

The FDA has granted an orphan drug designation to the novel PD-L1/4-1BB bispecific antibody ATG-101 for the treatment of patients with pancreatic cancer.

FDA Grants Orphan Drug Designation to Ezurpimtrostat for Cholangiocarcinoma

September 19th 2022

The FDA has granted an orphan drug designation to the novel autophagy/palmitoyl protein thioesterase-1 inhibitor ezurpimtrostat for the treatment of patients with cholangiocarcinoma.

FDA Grants Orphan Drug Status to SY-5609 for Pancreatic Cancer

September 16th 2022

The FDA has granted an orphan drug designation to the CDK7 inhibitor SY-5609 for use as a potential therapeutic option in patients with relapsed metastatic pancreatic cancer.

NVG-111 Generates Early Efficacy With Manageable Safety in Relapsed/Refractory CLL, MCL

September 14th 2022

The ROR1-targeting bispecific T-cell engager NVG-111 elicited promising responses with a manageable safety profile in patients with relapsed/refractory chronic lymphocytic leukemia or mantle cell lymphoma.

FDA Grants Orphan Drug Designation to DUNP19 for Osteosarcoma

September 13th 2022

The FDA has granted an orphan drug designation to DUNP19 for the treatment of osteosarcoma.

PRMT5 Inhibitor Exhibits Efficacy and Tolerability in NHL, Advanced Solid Tumors

September 12th 2022

GSK3326595, a PRMT5 inhibitor, displayed modest efficacy and safety signals that were consistent with those that were previously reported with the agent among patients with advanced solid tumors.

Enfortumab Vedotin Plus Pembrolizumab Produces Encouraging Responses in Metastatic Urothelial Cancer

September 12th 2022

The combination of enfortumab vedotin and pembrolizumab elicited a high overall response rate and a manageable safety profile in patients with locally advanced or metastatic urothelial cancer.

High-Dose MEDI5752 Induces Clinical Benefit in NSCLC at the Cost of Significant Toxicity

September 11th 2022

MEDI5752 plus chemotherapy doubled the duration of response and extended survival compared with pembrolizumab in patients with treatment-naïve nonsquamous non–small cell lung cancer.

DCC-3116 Displays Early Tolerability in RAS/RAF-Mutant Solid Tumors

September 11th 2022

The ULK1/2 inhibitor DCC-3116 was well tolerated as a monotherapy in patients with locally advanced or metastatic tumors harboring a RAS or RAF mutation.

Pembrolizumab Plus Abiraterone/Prednisone Shows Sustained Efficacy in Chemotherapy-Naïve mCRPC

September 10th 2022

Pembrolizumab plus abiraterone acetate and prednisone demonstrated continued efficacy and tolerability in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer.

ADP-A2M4CD8 Shows Promising Activity Across MAGE-A4+ Unresectable or Metastatic Tumor Types

September 10th 2022

An updated analysis of the phase 1 SURPASS trial showed that ADP-A2M4CD8, a next-generational autologous T-cell receptor designed to patients with solid tumors, may be an effective therapy in MAGE-A4-positive disease.

CLDN6 CAR T-Cell Therapy Shows Encouraging Efficacy in Relapsed/Refractory Advanced Solid Tumors

September 9th 2022

The investigational carcinoembryonic antigen claudin 6 (CLDN6)–directed CAR T-cell therapy BNT211-01 displayed clinical activity both as monotherapy and in combination with a CLDN6-encoding mRNA vaccine in patients with CLDN6-positive relapsed/refractory advanced solid tumors.