May 11, 2020
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FDA grants fast track status to several agents

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The FDA granted fast track designation to several therapies in development for hematology or oncology indications.

They include:

  • NBTXR3 (Nanobiotix), with or without cetuximab (Erbitux, Eli Lilly), for treatment of patients with locally advanced head and neck squamous cell carcinoma who are not eligible for platinum-based chemotherapy.

NBTXR3 — which includes an aqueous suspension of crystalline hafnium oxide nanoparticles to destroy tumors via cell death — is administered in a single dose prior to the first session of radiotherapy, which activates the treatment.

A phase 1 trial showed NBTXR3 induced promising rates of local control among elderly and frail patients with locally advanced HNSCC of the oral cavity or oropharynx who were unable to receive chemotherapy or cetuximab and, therefore, had limited therapeutic options.

  • ALX148 (ALX Oncology) for first-line treatment of patients with HNSCC and second-line treatment of patients with HER2-positive gastric or gastroesophageal junction carcinoma.

ALX148 — a next-generation CD47 myeloid checkpoint inhibitor — is designed to maximize the clinical benefit of anticancer therapies for various tumor types.

An open-label, multicenter phase 1 trial evaluated ALX148 in combination with pembrolizumab (Keytruda, Merck) or trastuzumab (Herceptin, Genentech). Data showed a 40% objective response rate among checkpoint inhibitor-naive patients with HNSCC that progressed on prior platinum therapy, as well as a 21% ORR among patients with gastric or gastroesophageal junction carcinoma whose disease progressed on prior anti-HER2 therapy.

  • ME-401 (MEI Pharma) for treatment of adults with relapsed or refractory follicular lymphoma.

The designation applies to use of ME-401 — a selective oral inhibitor of PI3 kinase-delta — for patients who received at least two prior systemic therapies.

MEI Pharma is conducting the phase 2 TIDAL trial to evaluate ME-401 as monotherapy for adults with relapsed or refractory follicular lymphoma after two or more systemic therapies, including chemotherapy and an anti-CD20 antibody.

  • Tipifarnib (Kura Oncology) for treatment of adults with relapsed or refractory angioimmunoblastic T-cell lymphoma, follicular T-cell lymphoma, or nodal peripheral T-cell lymphoma with T follicular helper phenotype.

Tipifarnib is a selective farnesyl transferase inhibitor that has shown durable anticancer activity in certain subsets of patients with solid tumors and hematologic malignancies.

Data presented at last year’s ASH Annual Meeting and Exposition showed tipifarnib exhibited durable activity as monotherapy for relapsed or refractory angioimmunoblastic T-cell lymphoma. Researchers reported an approximately 50% objective response rate among patients who had received a median three prior therapies.

The agent also induced a 70% ORR and 40% complete response rate among patients who had mutations in the killer-cell immunoglobulin-like receptor.

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  • Balstilimab (Agenus), an anti-PD-1 therapy, for treatment of women with advanced cervical cancer.

Agenus expects to file two biologics license applications with the FDA this year seeking accelerated approval of balstilimab monotherapy, as well as the combination of balstilimab and the anti-CTLA-4 therapy zalifrelimab (Agenus), for treatment of metastatic cervical cancer.

As HemOnc Today previously reported, the FDA granted fast track designation to the combination last month.

A study evaluated both treatment approaches for an all-comers, nonbiomarker-selected population of women with refractory cervical cancer who failed prior platinum chemotherapy with or without bevacizumab (Avastin, Genentech).

Updated data from a preplanned analysis of study showed a 26.5% objective response rate with the balstilimab-zalifrelimab combination and a 14.3% ORR for balstilimab monotherapy.

  • Sacituzumab govitecan (IMMU-132, Immunomedics) for treatment of certain adults with locally advanced or metastatic urothelial cancer.

The designation applies to use of the agent for patients who previously received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

Sacituzumab govitecan — an antibody-drug conjugate — combines an antibody to the Trop-2 antigen and releases SN-38, the metabolite of the chemotherapy drug irinotecan, directly into cancer cells and into the tumor microenvironment.

The phase 2 TROPHY U-01 study is evaluating the agent for 100 patients with metastatic urothelial carcinoma. Interim results showed a 29% overall response rate among 35 cisplatin-eligible patients who relapsed after or were refractory to PD-1 or PD-L1 inhibitors and platinum-based chemotherapy.