Pipeline Report: December 2021 | articles

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.

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.

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.

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.

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.

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.

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.

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.

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, 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 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.

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.

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.

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.

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

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.

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

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.

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

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.

Daratumumab plus talquetamab demonstrated a tolerable safety profile and induced responses in more than 75% of patients with relapsed/refractory multiple myeloma across dose levels.

Orca-T significantly improved graft-vs-host disease–free relapse-free survival and time to engraftment, significantly reduced acute and chronic GVHD, and showed a trend toward improved overall survival vs standard of care in patients with serious hematologic malignancies

Fixed-duration treatment with the bispecific antibody mosunetuzumab induced deep and durable responses with favorable tolerability in heavily pretreated patients with relapsed or refractory follicular lymphoma, meeting the primary end point of the ongoing phase 1/2b GO29781 trial.

Prior research has shown that the combination of trastuzumab deruxtecan plus pertuzumab may be superior to T-trastuzumab deruxtecan alone in patients with HER2-positive metastatic breast cancer and the combination is now under examination in the phase 3 DESTINY-Breast09 trial.

The addition of the bispecific antibody zanidatamab to single-agent chemotherapy was found to produce promising antitumor activity with acceptable tolerability in heavily pretreated patients with HER2-positive breast cancer.

A non-chemotherapy–based targeted regimen comprised of tucatinib, palbociclib, and letrozole resulted in prolonged central nervous system progression-free survival in patients with hormone receptor–positive, HER2-positive breast cancer.

Datopotamab deruxtecan showed highly encouraging and durable efficacy through overall response rates in patients with advanced or metastatic triple-negative breast cancer.

Retifanlimab demonstrated encouraging antitumor activity with favorable tolerability in patients with recurrent microsatellite instability–high or mismatch repair deficient endometrial cancer, according to data from the phase 1 POD1UM-101 trial.