Pipeline Report: May 2022 | Articles

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Galinpepimut-S Plus Pembrolizumab Displays Early Efficacy in WT1+ Ovarian Cancer

May 31st 2022

Galinpepimut-S in combination with the PD-1 inhibitor pembrolizumab elicited a clinical benefit in patients with Wilms’ tumor-1-positive relapsed/refractory platinum-resistant advanced metastatic ovarian cancer, according to top line-line data from a phase 1/2 trial (NCT03761914).

FDA Lifts Partial Clinical Hold on NEON-2 Trial Evaluating Davoceticept Plus Pembrolizumab in Advanced Malignancies

May 24th 2022

The FDA has lifted a partial clinical hold on the phase 1 NEON-2 trial investigating the use of davoceticept in combination with pembrolizumab in adult patients with advanced solid tumors or lymphoma.

Nivolumab Plus Axitinib Generates Promising Responses in Untreated Advanced RCC

May 24th 2022

The combination of nivolumab and axitinib achieved meaningful responses in treatment-naïve advanced renal cell carcinoma, according to results from a phase 1/2 trial (NCT03172754) presented at the 2022 Genitourinary Cancers Symposium.

Tilsotolimod Demonstrates Encouraging Activity, Safety in Early-Stage Melanoma

May 23rd 2022

The synthetic Toll-like receptor 9 agonist tilsotolimod reduced the sentinel lymph node biopsy positivity rate vs placebo in patients with localized, excised melanoma.

FDA Places Partial Clinical Hold on Phase 1 Trial Evaluating FHD-286 in Relapsed/Refractory AML and MDS

May 20th 2022

The FDA has placed a partial clinical hold on a phase 1 trial investigating FHD-286 as a treatment for patients with relapsed and/or refractory acute myeloid leukemia and myelodysplastic syndrome.

Sacituzumab Govitecan Under Further Exploration in Metastatic Urothelial Cancer

May 19th 2022

Sacituzumab govitecan will be further evaluated in patients with locally advanced unresectable or metastatic urothelial cancer that has progressed after prior platinum or checkpoint inhibitor therapy, as a part of the phase 3 TROPiCS-04 trial.

Trial Assessing CAR T-Cell Therapy ACLX-001 in Relapsed/Refractory Multiple Myeloma Begins

May 19th 2022

Investigators have initiated a phase 1 trial exploring ACLX-001, a novel CAR T-cell therapy using the ARC-SparX platform, in patients with relapsed/refractory multiple myeloma.

Frontline Datopotamab Deruxtecan/Durvalumab Combo Elicits Encouraging Responses in TNBC

May 19th 2022

The combination of the TROP2-directed antibody-drug conjugate datopotamab deruxtecan and durvalumab showcased early activity with acceptable safety when used as first-line treatment in patients with locally advanced or metastatic triple-negative breast cancer, according to data from the phase 1b/2 BEGONIA trial.

TLR9 Agonist Vidutolimod Shows Promise in Combination With Pembrolizumab in PD-1–Refractory Melanoma

May 19th 2022

The combination of intratumoral vidutolimod and intravenous pembrolizumab demonstrated promising clinical activity in patients with PD-1 refractory melanoma.

Sabizabulin Yields Encouraging rPFS, Tolerable Toxicity Profile in Previously Treated mCRPC

May 17th 2022

The utilization of sabizabulin in patients with metastatic castration-resistant prostate cancer who progressed on androgen receptor-targeting therapy yielded significant and durable objective tumor responses, according to results of a phase 1b/2 trial (NCT03752099).

Infigratinib Generates Activity in FGFR-Mutated Urothelial Carcinoma

May 16th 2022

Infigratinib yielded notable activity and tolerability in patients with localized upper tract urothelial carcinoma harboring FGFR1/2/3 mutations.

ARAFOR Data Reveal Favorable Safety, Tolerability With Long-Term Darolutamide Exposure in mCRPC

May 14th 2022

Darolutamide was found to have a favorable safety and tolerability profile in patients with metastatic castration-resistant prostate cancer who were enrolled to the phase 1 ARAFOR study and received extended treatment with the agent for more than 4 years.

Navicixizumab/Paclitaxel Combo Demonstrates Early Promise in Platinum-Resistant Ovarian Cancer

May 13th 2022

The addition of navicixizumab to paclitaxel produced encouraging responses with manageable toxicity in patients with platinum-resistant ovarian cancer irrespective of prior treatment with bevacizumab.

Vibostolimab/Pembrolizumab Combo Elicits Antitumor Activity in Metastatic Cervical Cancer

May 11th 2022

Two investigated doses of vibostolimab in combination with pembrolizumab resulted in comparable antitumor activity and safety in patients with locally advanced or metastatic cervical cancer who were naïve to PD-1/PD-L1 inhibitors, regardless of PD-L1 status.

VB10.16 Plus Atezolizumab Elicits Responses in HPV16-Positive Cervical Cancer

May 10th 2022

The first-in-class, off-the-shelf therapeutic cancer vaccine VB10.16 in combination with atezolizumab generated positive responses in heavily pretreated patients with HPV16-positive advanced cervical cancer.

CTX-009/Paclitaxel Combo Demonstrates Antitumor Activity, Favorable Tolerability in Biliary Tract Cancer

May 5th 2022

A novel combination comprised of the investigational bispecific antibody CTX-009 and paclitaxel was found to produce responses in 4 subtypes of biliary tract cancer with favorable safety and tolerability, according to interim results from an ongoing phase 2 trial.

CG0070 Plus Nivolumab Under Investigation in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer

May 4th 2022

The safety and efficacy of the combination of the oncolytic immunotherapy CG0070 and nivolumab is under exploration as a potential therapeutic option in patients with muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy, as part of the phase 1b CORE-002 trial.

ARO-HIF2 Lowers HIF2α Expression and Demonstrates Favorable Safety Profile in Clear Cell RCC

May 4th 2022

The investigational RNA interference therapy, ARO-HIF2, reduced levels of hypoxia inducible factor-2 alpha expression and had acceptable tolerability when used in patients with clear cell renal cell carcinoma, according to data from the phase 1b AROHIF21001 trial.