Pipeline Report: December 2022 | Articles

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Mezigdomide Shows Encouraging Activity With Dexamethasone in Heavily Pretreated Patients With Multiple Myeloma

December 11th 2022

Mezigdomide showed notable clinical activity and a manageable safety profile when combined with dexamethasone in patients with triple-class relapsed or refractory multiple myeloma.

Zilovertamab/Ibrutinib Elicits Durable Responses With Favorable Tolerability in MCL and CLL

December 11th 2022

The combination of zilovertamab and ibrutinib resulted in promising clinical response and progression-free survival rates and showcased a tolerable toxicity profile in patients with mantle cell lymphoma and chronic lymphocytic leukemia.

Rapcabtagene Autoleucel Induces Deep, Durable Responses in Relapsed/Refractory DLBCL

December 11th 2022

The CD19-targeted CAR T-cell therapy rapcabtagene autoleucel was found to be well tolerated and to yield durable responses in patients with relapsed/refractory diffuse large B-cell lymphoma who had undergone 2 or more prior lines of therapy.

Magrolimab Plus Azacitidine and Venetoclax Produces Promising Responses in Newly Diagnosed, High-Risk AML

December 11th 2022

The addition of magrolimab to azacitidine and venetoclax produced high complete response rates and was well tolerated as first-line therapy in patients with high-risk de novo and secondary acute myeloid leukemia regardless of TP53 mutation status.

Iberdomide Alone or in Combination With Anti-CD20 Monoclonal Antibodies Shows Early Efficacy in R/R Lymphoma

December 11th 2022

Iberdomide monotherapy or in combination with anti-CD20 antibodies was well tolerated and found to elicit encouraging responses in patients with relapsed or refractory lymphoma.

Ziftomenib Showcases Clinical Activity, Favorable Tolerability in Relapsed/Refractory AML

December 11th 2022

Ziftomenib monotherapy had a manageable toxicity profile and provided pronounced antileukemic activity when given at a 600-mg dose in heavily pretreated patients with relapsed or refractory acute myeloid leukemia.

Pirtobrutinib Shows High Response Rates in Heavily Pretreated Waldenström Macroglobulinemia

December 11th 2022

The non-covalent BTK inhibitor pirtobrutinib showed high levels of response in heavily pretreated patients with Waldenström macroglobulinemia, regardless of prior treatment with a covalent BTK inhibitor.

Forimtamig Produces High ORR With IV and Subcutaneous Delivery in Relapsed/Refractory Multiple Myeloma

December 10th 2022

The GPRC5D- and CD3-directed bispecific antibody forimtamig led to high response rates in patients with relapsed or refractory multiple myeloma regardless of subcutaneous or intravenous administration, according to updated findings from a phase 1 dose-escalation study.

Teclistamab Triplet Shows Encouraging Responses and Safety in Relapsed/Refractory Multiple Myeloma

December 10th 2022

Administration of teclistamab in combination with daratumumab and lenalidomide demonstrated promising overall response rates and tolerability in patients with relapsed/refractory multiple myeloma who had prior lenalidomide exposure, according to initial data from the phase 1b MajesTEC-2 trial.

Lintuzumab-Ac225 With Intensive Chemo Has Encouraging Efficacy Signal in High-risk AML

December 10th 2022

Sequential administration of lintuzumab-Ac225 after salvage chemotherapy proved to be safe and feasible, and to result in high response and minimal residual disease negativity rates in high-risk patients with relapsed/refractory acute myeloid leukemia.

Talquetamab Continues to Show Robust Efficacy With Acceptable Safety in Heavily Pretreated Multiple Myeloma

December 10th 2022

Talquetamab elicited overall response rates of higher than 70% when administered in weekly or every-other-week schedules in heavily pretreated patients with relapsed or refractory multiple myeloma.

Trastuzumab Deruxtecan With or Without Pertuzumab Demonstrates Early Safety and Efficacy Signals in HER2+ MBC

December 9th 2022

Trastuzumab deruxtecan, both as monotherapy and in combination with pertuzumab, displayed encouraging efficacy with no new safety signals among patients with HER2-positive metastatic breast cancer, according to findings from the dose expansion part of the phase 1b/2 DESTINY-Breast07 trial.

ARV-471 Monotherapy Demonstrates Clinical Benefit in ER+/HER2- Advanced Breast Cancer

December 8th 2022

ARV-471 monotherapy elicited a significant clinical benefit rate in patients with estrogen receptor–positive/HER2-negative locally advanced or metastatic breast cancer who had undergone prior hormonal therapy and chemotherapy, including those with ESR1 mutations.

Frontline Adagrasib Plus Pembrolizumab Elicits Encouraging Clinical Activity in KRAS G12C+ Advanced NSCLC

December 8th 2022

Concurrent adagrasib and pembrolizumab produced preliminary activity when administered as first-line treatment in patients with non–small cell lung cancer harboring a KRAS G12C mutation, irrespective of PD-L1 status, according to data from the KRYSTAL-1 phase 1b and the KRYSTAL-7 phase 2 cohorts.

FDA Grants Breakthrough Therapy Designation to Revumenib in Relapsed/Refractory KMT2A-rearranged Acute Leukemia

December 6th 2022

The FDA has granted a breakthrough therapy designation to revumenib for the treatment of adult and pediatric patients with relapsed/refractory acute leukemia harboring a KMT2A rearrangement.

Budigalimab Plus ABBV-151 Demonstrates Variable Activity Across Locally Advanced or Metastatic Solid Tumors

December 6th 2022

The addition of budigalimab to ABBV-151 was well tolerated and significantly enhanced responses in patients with locally advanced or metastatic solid tumors.

Phase 1 Trial Pauses Enrollment for Evaluation of TH1902 in Sortilin-Expressing Cancers

December 5th 2022

Enrollment has been paused for a phase 1 trial investigating the peptide-drug conjugate TH1902 for the treatment of patients with sortilin-expressing cancers.

Olaparib Plus Durvalumab and Bevacizumab Provides Durable Survival in Non-Germline, BRCA+ Relapsed Ovarian Cancer

December 4th 2022

Olaparib plus durvalumab and bevacizumab led to prolonged survival and disease control without causing additive toxicity in patients with non-germline BRCA-mutated, platinum-sensitive, relapsed ovarian cancer.

FDA Grants Orphan Drug Designation to AUM302 for Neuroblastoma

December 2nd 2022

The FDA has granted an orphan drug designation to AUM302 for the treatment of patients with neuroblastoma.

FDA Grants Fast Track Designation to Pelareorep for Advanced/Metastatic Pancreatic Cancer

December 1st 2022

The FDA has granted a fast track designation to pelareorep for use in combination with atezolizumab, gemcitabine, and nab-paclitaxel for the treatment of patients with advanced or metastatic pancreatic cancer.