Pipeline Report: August 2022 | Articles

Subcutaneous Isatuximab Elicits Comparable Efficacy, Safety to IV Formulation in Relapsed/Refractory Myeloma

August 31st 2022

Subcutaneous administration of isatuximab through a syringe pump or on-body delivery system demonstrated similar efficacy and safety compared with intravenous isatuximab when combined with pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma.

FDA Allows Trial Enrollment to Resume for Single-Agent Emavusertib in AML/MDS

August 30th 2022

The FDA has granted permission for enrollment to resume in the monotherapy phase 1a portion of the phase 1/2 TakeAim Leukemia trial evaluating emavusertib in relapsed/refractory acute myeloid leukemia or high-risk myelodysplastic syndromes.

REGN5458 Elicits Promising Responses, Safety in Relapsed/Refractory Myeloma

August 27th 2022

REGN5458 produced durable responses with low rates of cytokine release syndrome in patients with relapsed/refractory multiple myeloma.

Cevostamab Elicits Responses in Younger and Older Patients with Relapsed/Refractory Myeloma

August 27th 2022

Cevostamab generated responses and was well tolerated in younger and older patients with relapsed/refractory multiple myeloma.

Abivertinib Demonstrates Response and Survival Benefits in Pretreated EGFR T790M–Mutant NSCLC

August 23rd 2022

The novel third-generation EGFR inhibitor abivertinib generated a positive overall response rate and overall survival in heavily pretreated Chinese patients with EGFR T790M–mutated non–small cell lung cancer who failed treatment on a first-line EGFR TKI, according to long-term follow-up data from a phase 1/2 trial (NCT02330367).

Maintenance With Niraparib and Ipilimumab Demonstrates PFS Benefit in Pancreatic Cancer

August 23rd 2022

Niraparib plus ipilimumab maintenance therapy elicited encouraging progression-free survival results in patients with advanced pancreatic cancer who achieved a stable response to platinum-based chemotherapy.

FDA Grants Breakthrough Therapy Designation to Taletrectinib for ROS1+ NSCLC

August 23rd 2022

The FDA has granted a breakthrough therapy designation to taletrectinib for use as a potential therapeutic option in adult patients with advanced or metastatic ROS1-positive non–small cell lung cancer who were ROS1 inhibitor naïve or who previously received crizotinib.

FDA Grants Orphan Drug Designation to Fixed-Dose Senaparib/Temozolomide Combo for SCLC

August 19th 2022

The FDA has granted an orphan drug designation to the fixed-dose combination capsule of the PARP inhibitor senaparib and temozolomide for the treatment of adult patients with small cell lung cancer.

FDA Lifts Partial Clinical Hold on TakeAim Lymphoma Trial Evaluating Emavusertib in B-cell Malignancies

August 18th 2022

The FDA has lifted a partial clinical hold on the open-label, dose-escalating phase 1/2 TakeAim Lymphoma trial investigating the safety and efficacy of emavusertib in patients with relapsed or refractory B-cell malignancies.

Ruxolitinib/Pomalidomide Combo Shows Feasibility in Myelofibrosis With Anemia

August 16th 2022

A combination regimen comprised of ruxolitinib and pomalidomide was found to be safe and feasible in a cohort of intermediate-2 and high-risk patients with primary or secondary myelofibrosis and anemia, according to data from the phase 1b/2 MPNSG-0212 trial.

Subcutaneous Epcoritamab Plus R-DHAX/C Shows Promising Preliminary Activity in ASCT-Eligible, R/R DLBCL

August 15th 2022

Raul Cordoba, MD, PhD, discussed the efficacy and safety findings from cohort 4 of the EPCORE NHL-2 trial, the benefits observed with epcoritamab monotherapy in patients who did not proceed to transplant, and what the addition of epcoritamab to R-DHAX/C could mean for patients with relapsed/refractory DLBCL.

Nivolumab/Ipilimumab Combo Provides Long-Term Survival Benefit in Advanced HCC After Sorafenib

August 13th 2022

The dual immunotherapy combination comprised of nivolumab given at 1 mg/kg and ipilimumab given at 3 mg/kg provided durable responses and long-term survival benefit in patients with advanced hepatocellular carcinoma following treatment with sorafenib.

FDA Grants Orphan Drug Designation to THIO in Small Cell Lung Cancer

August 9th 2022

The FDA has granted an orphan drug designation to THIO for the treatment of patients with small cell lung cancer.

Datopotamab Deruxtecan/Pembrolizumab With or Without Chemotherapy Elicits Responses in Advanced NSCLC

August 9th 2022

The combination of datopotamab deruxtecan and pembrolizumab, with or without platinum-based chemotherapy, displayed promising efficacy and a manageable safety profile in patients with advanced/metastatic non–small cell lung cancer.

Amivantamab/Lazertinib/Chemo Combo Achieves 50% ORR in Pretreated EGFR-Mutant NSCLC

August 8th 2022

Amivantamab in combination with lazertinib plus carboplatin and pemetrexed elicited encouraging responses in pretreated patients with EGFR-mutant non–small cell lung cancer, according to findings from the phase 1 CHRYSALIS-2 trial.

Sotorasib Plus SHP2 Inhibition Elicits Promising Preliminary Activity in KRAS G12C–Mutated NSCLC

August 7th 2022

The combination of sotorasib and the small molecule SHP2 inhibitor RMC-4630 led to an investigator-assessed objective response rate of 27% and 50% in pretreated and KRAS G12C inhibitor–naïve patients with non–small cell lung cancer, respectively.

Sitravatinib/Tislelizumab Combo Induces Antitumor Activity in PD-L1+ Advanced NSCLC

August 7th 2022

Sitravatinib in combination with tislelizumab demonstrated a confirmed investigator-assessed overall response rate of 30.4% in patients with PD-L1–positive, treatment-naïve, locally advanced or metastatic squamous non–small cell lung cancer.

GDC-6036 Monotherapy Elicits Promising Responses in KRAS G12C–Mutant NSCLC

August 7th 2022

GDC-6036, a novel KRAS G12C inhibitor, produced encouraging antitumor activity with a manageable safety profile as a single agent in previously treated patients with KRAS G12C–mutated NSCLC, according to data from a phase 1a trial.

Larotrectinib Demonstrates Favorable Long-Term Responses in NTRK Fusion–Positive Lung Cancer

August 6th 2022

Larotrectinib continued to elicit durable responses and a low toxicity profile in patients with NTRK fusion–positive lung cancer, according to long-term follow-up data from the phase 2 NAVIGATE trial and phase 1 LOXO-TRK-14001 trial.

Ociperlimab Plus Tislelizumab Demonstrates Antitumor Activity in PD-L1+ NSCLC

August 6th 2022

Ociperlimab, an anti-TIGIT monoclonal antibody, plus the anti–PD-L1 monoclonal antibody tislelizumab induced promising efficacy in adults with treatment-naïve, metastatic, PD-L1–positive non–small cell lung cancer, according to data from the dose-expansion cohort of the AdvanTIG-105 trial.