Pipeline Report: December 2021 | Articles

Novel Combination Looks to Capitalize on Synergy of B7-H3/PD-1 Blockade

December 30th 2021

The investigational monoclonal antibody enoblituzumab has demonstrated activity in preclinical studies and in combination with pembrolizumab in phase 1/2 studies in patients with checkpoint inhibitor–naïve head and neck squamous cell carcinoma and non–small cell lung cancer.

Pembrolizumab/Lenvatinib Plus Belzutifan or Quavonlimab Under Investigation in Advanced Clear Cell RCC

December 20th 2021

A phase 3 clinical trial will compare the safety and efficacy of a co-formulation of pembrolizumab and quavonlimab plus lenvatinib, and that of pembrolizumab, belzutifan, and lenvatinib, vs pembrolizumab/lenvatinib alone in the frontline treatment of patients with advanced renal cell carcinoma.

Belantamab Mafodotin/Pd Triplet Demonstrates Manageable Safety Profile in Relapsed/Refractory Myeloma

December 17th 2021

The triplet regimen of belantamab mafodotin plus pomalidomide and dexamethasone was revealed to have a manageable safety profile, which is consistent with the known individual safety profiles of belantamab mafodotin or pomalidomide and dexamethasone, in patients with relapsed/refractory multiple myeloma.

Adavosertib Elicits Efficacy in RAS/TP53+ mCRC With Potential Additive Benefit in Left-Sided Tumors

December 16th 2021

The WEE1 inhibitor adavosertib improved progression-free survival with a tolerable safety profile compared with active monitoring in patients with RAS/TP53-mutated metastatic colorectal cancer.

Neoadjuvant Trastuzumab Deruxtecan Dosed in First Patient With Early-Stage HER2+ Breast Cancer

December 16th 2021

The first patient with high-risk, early-stage HER2-positive breast cancer has received a dose of neoadjuvant fam-trastuzumab deruxtecan-nxki as part of the global, phase 3 DESTINY-Breast11 trial.

APVO436 Demonstrates Manageable Safety With Anti-Neoplastic Activity in Relapsed/Refractory AML/MDS

December 15th 2021

The investigational bispecific antibody APVO436 demonstrated tolerability with encouraging anti-neoplastic efficacy in patients with relapsed/refractory acute myeloid leukemia or myelodysplastic syndrome, according to updated findings from an ongoing phase 1 trial.

Cilta-Cel Demonstrates Durable Responses at 2 Years Across Multiple Subgroups in R/R Myeloma

December 14th 2021

Data from a longer follow-up analysis of the phase 1/2 CARTITUDE-1 trial demonstrated that all evaluated subgroups of patients with relapsed/refractory multiple myeloma maintained durable responses with ciltacabtagene autoleucel.

Efficacy of Cevostamab Increases With Higher Doses in Heavily Pretreated Multiple Myeloma

December 14th 2021

Cycle 1 double step-up dosing with cevostamab demonstrated encouraging activity with effective cytokine release syndrome mitigation in patients with heavily pretreated relapsed/refractory multiple myeloma, supporting further development of the dual-targeted bispecific antibody.

Tafasitamab/Lenalidomide Plus R-CHOP Found to be Tolerable, Active in Untreated DLBCL

December 14th 2021

The addition of tafasitamab and lenalidomide to rituximab, cyclophosphamide, doxorubicin, and prednisone demonstrated increased but generally comparable adverse effects and higher, prolonged, and deeper responses vs the combination of tafasitamab and R-CHOP alone in patients with previously untreated diffuse large B-cell lymphoma.

YTB323 Shows Encouraging Efficacy in Relapsed/Refractory DLBCL

December 14th 2021

YTB323, a novel, autologous CD19-directed CAR-T cell therapy, displayed a favorable safety profile and efficacy across multiple dose levels in adult patients with relapsed/refractory diffuse large b-cell lymphoma.

Venetoclax-Based Triplet Continues to Confer Tolerable Safety, Deep Responses in t(11;14) Relapsed/Refractory Multiple Myeloma

December 14th 2021

Venetoclax at either 400 mg or 800 mg plus daratumumab and dexamethasone elicited deep durable responses and was associated with a tolerable safety profile in patients with t(11;14) relapsed/refractory multiple myeloma.

Cilta-Cel Continues to Impress With Durable and Deep Responses in Relapsed/Refractory Multiple Myeloma

December 13th 2021

Ciltacabtagene autoleucel elicited a 97.9% objective response rate and an 82.5% stringent complete response rate in patients with relapsed/refractory multiple myeloma at a median of approximately 2 years of follow-up.

Higher-Dosed Selinexor Plus Pomalidomide and Dexamethasone Demonstrates Efficacy in Relapsed/Refractory Multiple Myeloma

December 13th 2021

The 60mg phase 2 dose of selinexor plus pomalidomide and dexamethasone produced more durable and deep responses than the lesser selinexor dose for relapsed or refractory multiple myeloma.

Cilta-Cel Provides Superior Option Vs Standard Regimens in Triple-Class Exposed Multiple Myeloma

December 13th 2021

Comparative data from the phase 1 CARTITUDE-1 trial and the real-world LocoMMotion study demonstrated that ciltacabtagene autoleucel bested standard options for patients with triple-class exposed multiple myeloma.

First-Line Itolizumab Associated With High Rates of Clinical Response, Tolerability in Acute GVHD

December 13th 2021

The first-in-class monoclonal antibody treatment for acute graft-versus-host disease had durable responses and tolerability for patients.

Glofitamab Monotherapy, Plus Obinutuzumab Show High Responses in Relapsed/Refractory Follicular Lymphoma

December 13th 2021

Glofitamab, an investigational CD20xCD3 bispecific antibody, induced high response rates as monotherapy or in combination with obinutuzumab in patients with multiple relapsed or refractory follicular lymphoma.

Liso-Cel Induces Durable Responses in Relapsed/Refractory B-Cell Lymphomas

December 13th 2021

Treatment with lisocabtagene maraleucel demonstrated durable responses in patients with relapsed/refractory large B-cell lymphomas.

Cilta-cel Shows Greater Clinical Benefit Than SOC in Triple-Class Relapsed/Refractory Myeloma

December 12th 2021

Ciltacabtagene autoleucel demonstrated a significant advantage over physician’s choice of treatment with regard to overall survival, progression-free survival, time to next treatment, and overall response rate, underscoring its potential for use in patients with triple-class relapsed/refractory multiple myeloma.

Phase 3 Trial Set to Evaluate Venetoclax Plus Acalabrutinib or Obinutuzumab in Treatment-Naive CLL/SLL

December 12th 2021

The combinations of venetoclax plus acalabrutinib or obinutuzumab will be evaluated in the phase 3 MAJIC trial.

Loncastuximab Tesirine/Ibrutinib Combination Elicits Encouraging Activity in Relapsed/Refractory DLBCL

December 11th 2021

Treatment with ibrutinib plus loncastuximab tesirine-lpyl resulted in high objective and complete response rates and an acceptable safety profile in patients with relapsed/refractory diffuse large B-cell lymphoma, according to findings from an interim analysis of the phase 1/2 LOTIS-3 trial (NCT03684694) that were presented at the 2021 ASH Annual Meeting and Exposition.