Pharmacosmos initiates phase III clinical trial of trilaciclib in limited-stage small cell lung cancer

Pharmacosmos initiates phase III clinical trial of trilaciclib in limited-stage small cell lung cancer

MORRISTOWN, NJ, UNITED STATES, March 17, 2026 /EINPresswire.com/ -- Pharmacosmos today announced the initiation of a phase III, randomised, double-blind, placebo-controlled, multicentre clinical trial evaluating the efficacy and safety of trilaciclib in participants with limited-stage small cell lung cancer. The study is being conducted at clinical sites in the United States, EU and the United Kingdom.

The trial will compare trilaciclib with placebo when administered prior to standard chemoradiotherapy and is designed to assess whether trilaciclib can reduce chemotherapy-induced myelosuppression and improve treatment tolerability in patients with limited-stage small cell lung cancer.

Trilaciclib is currently approved and marketed in the United States for use prior to platinum/etoposide-containing or topotecan-containing regimens in adults with extensive-stage small cell lung cancer, where it is indicated to decrease the incidence of chemotherapy-induced myelosuppression.
Limited-stage small cell lung cancer represents an earlier stage of the disease, in which the cancer is confined to one side of the chest and treatment is typically delivered with curative intent using concurrent chemotherapy and radiation (chemoradiotherapy). As with extensive-stage disease, treatment of limited-stage disease is associated with chemotherapy-induced myelosuppression, which can lead to dose reductions, treatment delays and an increased risk of complications.

Chemotherapy-induced myelosuppression is traditionally managed once it occurs. The study evaluates a novel approach in which bone marrow protection is administered prior to chemotherapy. Trilaciclib is a short-acting CDK4/6 inhibitor administered intravenously prior to chemotherapy. By transiently inducing cell-cycle arrest in haematopoietic stem and progenitor cells, trilaciclib is designed to protect all blood cell lineages from chemotherapy-induced damage.

“With this phase III study, we are extending the clinical development of trilaciclib into limited-stage small cell lung cancer,” said Lars Lykke Thomsen, Executive Vice President and Chief Medical Officer at Pharmacosmos. “We look forward to evaluating the role of bone marrow protection with trilaciclib in patients with limited-stage small cell lung cancer receiving intensive chemoradiotherapy.”

Pharmacosmos has submitted regulatory applications for trilaciclib in extensive-stage small cell lung cancer outside the United States.

About the study
The phase III study is a randomised, double-blind, placebo-controlled, multicentre trial conducted in the United States, EU and the United Kingdom evaluating trilaciclib administered prior to standard chemoradiotherapy in participants with limited-stage small cell lung cancer. The study will assess efficacy and safety endpoints related to chemotherapy-induced myelosuppression and overall treatment tolerability.

About trilaciclib
Trilaciclib is an intravenous CDK4/6 inhibitor designed to be administered prior to chemotherapy to protect bone marrow function. It is approved in the United States for use in adults receiving a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

About Pharmacosmos
Pharmacosmos A/S is a global leader in carbohydrate chemistry and innovative treatments for iron deficiency and iron deficiency anaemia. Building on our foundational expertise in carbohydrate chemistry and cell cycle biology, we develop innovative treatments for unmet patient needs, with a focus on iron metabolism and blood-related disorders. Founded in 1965 and headquartered in Denmark, our team is made up of more than 700 specialists across the UK, Ireland, the Nordics, Germany, Canada, the USA, and China

Important Safety Information

CONTRAINDICATION

COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

WARNINGS AND PRECAUTIONS

Injection-Site Reactions, Including Phlebitis And Thrombophlebitis

COSELA administration can cause injection-site reactions, including phlebitis and thrombophlebitis, which occurred in 56 (21%) of 272 patients receiving COSELA in clinical trials, including Grade 2 (10%) and Grade 3 (0.4%) adverse reactions. Monitor patients for signs and symptoms of injection-site reactions, including infusion-site pain and erythema during infusion. For mild (Grade 1) to moderate (Grade 2) injection-site reactions, flush line/cannula with at least 20 mL of sterile 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP after end of infusion. For severe (Grade 3) or life-threatening (Grade 4) injection-site reactions, stop infusion and permanently discontinue COSELA. Injection-site reactions led to discontinuation of treatment in 3 (1%) of the 272 patients.

Acute Drug Hypersensitivity Reactions

COSELA administration can cause acute drug hypersensitivity reactions, which occurred in 16 (6%) of 272 patients receiving COSELA in clinical trials, including Grade 2 reactions (2%). Monitor patients for signs and symptoms of acute drug hypersensitivity reactions. For moderate (Grade 2) acute drug hypersensitivity reactions, stop infusion and hold COSELA until the adverse reaction recovers to Grade ≤1. For severe (Grade 3) or life-threatening (Grade 4) acute drug hypersensitivity reactions, stop infusion and permanently discontinue COSELA.

Interstitial Lung Disease/Pneumonitis

Severe, life-threatening, or fatal interstitial lung disease (ILD) and/or pneumonitis can occur in patients treated with cyclin-dependent kinases (CDK)4/6 inhibitors, including COSELA, with which it occurred in 1 (0.4%) of 272 patients receiving COSELA in clinical trials. Monitor patients for pulmonary symptoms of ILD/pneumonitis. For recurrent moderate (Grade 2) ILD/pneumonitis, and severe (Grade 3) or life-threatening (Grade 4) ILD/pneumonitis, permanently discontinue COSELA.

Embryo-Fetal Toxicity

Based on its mechanism of action, COSELA can cause fetal harm when administered to a pregnant woman. Females of reproductive potential should use an effective method of contraception during treatment with COSELA and for at least 3 weeks after the final dose.

ADVERSE REACTIONS

Serious adverse reactions occurred in 30% of patients receiving COSELA. Serious adverse reactions reported in >3% of patients who received COSELA included respiratory failure, hemorrhage, and thrombosis.

Fatal adverse reactions were observed in 5% of patients receiving COSELA. Fatal adverse reactions for patients receiving COSELA included pneumonia (2%), respiratory failure (2%), acute respiratory failure (<1%), hemoptysis (<1%), and cerebrovascular accident (<1%).

Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received COSELA. Adverse reactions leading to permanent discontinuation of any study treatment for patients receiving COSELA included pneumonia (2%), asthenia (2%), injection-site reaction, thrombocytopenia, cerebrovascular accident, ischemic stroke, infusion-related reaction, respiratory failure, and myositis (<1% each).

Infusion interruptions due to an adverse reaction occurred in 4.1% of patients who received COSELA.

The most common adverse reactions (≥10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

DRUG INTERACTIONS

COSELA is an inhibitor of OCT2, MATE1, and MATE-2K. Co-administration of COSELA may increase the concentration or net accumulation of OCT2, MATE1, and MATE-2K substrates in the kidney (e.g., dofetilide, dalfampridine, and cisplatin).

To report suspected adverse reactions, contact Pharmacosmos Therapeutics at 1-800-790-4189 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

This information is not comprehensive. Please see the full Prescribing Information.



COMPL2026-005-C-110226

Christian L. Madsen VP, Global Marketing & Communications
Pharmacosmos
+45 59 48 59 59
clm@pharmacosmos.com

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