To decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen

For extensive-stage small cell lung cancer (ES-SCLC)

HEAR FROM A PEER NEAR YOU

COSELA: MY STANDARD OF CARE FOR ES-SCLC PATIENTS

Hear leading healthcare provider, Dr. Leo Shunyakov, share key insights about the novel, proactive, and multilineage mechanism of action (MOA) of COSELA.

NOTE: Dr. Shunyakov is appearing on behalf of Pharmacosmos Therapeutics Inc.

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Hi, I'm Leo Shunyakov, Medical Oncologist and Hematologist with the Central Care Cancer Center in Bolivar, MO.

In this video I'm going to discuss COSELA as a treatment option to reduce the incidence of chemo-induced myelosuppression for patients being treated with chemotherapy for extensive-stage small cell lung cancer, and what I’ve experienced with patients in my own practice.

COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for ES-SCLC.

Traditional reactive therapies for treating chemo-induced myelosuppression come with their own risk and side effects, which I have seen in some of my own patients.

Since COSELA was approved, I've administered it to several of my extensive-stage small cell lung cancer patients and we're starting to use it more widely throughout the practice.

The data showing the reduction in Grade 4 severe neutropenia in the pivotal study was significant and of interest to me. This primary endpoint of the study showed 49.1% of those not receiving COSELA with grade 4 severe neutropenia and only 1.9% for patients that received COSELA. 

Before I considered COSELA as a proactive treatment option for all of my appropriate extensive-stage small cell lung cancer patients, I looked at the other multilineage efficacy data, shown in this graphic, which was really impactful.

After reviewing the efficacy and safety,

I looked at the patient-reported outcomes, which were evaluated in a retrospective pooled analysis of three clinical studies to measure COSELA's effects on the patient experience.

Upon the FDA approval of COSELA, our initial focus was on the efficacy and safety data. Now, my perspective of COSELA has expanded to include the patient reported outcomes data, an important measure I consider in my evaluation of new agents.

The perspective of my patients with extensive-stage small cell lung cancer during their experience being treated with chemotherapy is of interest to me. I’m always taking their experience into consideration, and how treatments may impact that.

So, looking at these data has been helpful to me in seeing the overall patient experience on COSELA.

I also wanted to factor in COSELA’s mechanism of action and the role it may play in my patients’ treatment regimen.

When given prior to chemotherapy, COSELA essentially puts the hematopoietic stem cell progenitor cells, or HSPCs, to sleep in the G1 phase of the cell cycle.

HSPCs are typically vulnerable to chemotherapy, resulting in the depletion of multiple blood cell lineages. This can lead to certain side effects like neutropenia, anemia, and thrombocytopenia.

COSELA proactively helps protect HSPCs to enable myeloprotection. And when given prior to chemotherapy, COSELA transiently affects CDK 4 and 6 activity. This makes HSPCs less vulnerable to chemotherapy, which then in turn may help decrease hematologic side effects from the chemotherapy, such as thrombocytopenia, neutropenia, and anemia. The HSPCs can then resume their role in maintaining bone marrow function and cell production.

These multilineage data on the potential reduction from chemo-induced myelosuppression, in addition to the data provided on patient-reported outcomes, have been of great importance in my decision to use COSELA.

In my experience, all of my appropriately-treated extensive-stage small cell lung cancer patients with pre-existing conditions benefit from the use of COSELA prior to their chemotherapy regimen.

In fact, with COSELA, I’ve been able to administer full doses of chemotherapy while at the same time reducing some of the harmful chemo-induced myelosuppressive consequences. It’s worth noting that you can still use other supportive care treatments in conjunction with COSELA if needed.

With COSELA, I’ve been able to change my approach to the standard of care for my patients with extensive-stage small cell lung cancer.

I consider COSELA as an option and I’ve seen in my practice that it can be helpful for all adult patients who may experience myelosuppression. Patients without comorbidities can still develop anemia, neutropenia, or thrombocytopenia, so it’s really worth considering for all appropriate patient types.

Thank you for taking the time to watch this video. Please stay tuned for the Important Safety Information to follow. To find out more about COSELA, please visit COSELA.com.

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 or 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 G1 Therapeutics at 1-800-790-G1TX or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

INDICATION: COSELA is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer (ES-SCLC).

THE FIRST AND ONLY PROACTIVE MULTILINEAGE MYELOPROTECTION THERAPY

In a recent survey, 88% of 301 patients with solid tumors reported that chemotherapy-induced myelosuppression had a moderate to major impact on their lives.2

KOL Image and Credentials
Having a treatment that helps protect hematopoietic stem and progenitor cells prior to therapy is attractive because then we aren’t scrambling very often after treatment to find transfusion products for our patients during a blood shortage.
Leo Shunyakov, MD
Director of Oncology
Central Care Center
Bolivar, MO
KOL Image and Credentials
In our clinic, the care team is in frequent contact with patients on chemotherapy and we recognize the burden of myelosuppressive therapy on both patients and their caregivers in terms of hospitalizations or dose delays. Having a proactive therapy that can help reduce some of this burden is important to us.
Abdur Shakir, MD
Director
Sarah Bush Lincoln Regional Cancer Center
Mattoon, IL

ONLY COSELA HELPS PROVIDE MULTILINEAGE MYELOPROTECTION BEFORE CHEMOTHERAPY DAMAGE

Learn More

THERE WAS AN 85% INCREASE IN COSELA USE IN A 12-MONTH PERIOD3*

*Data on file, Pharmacosmos Therapeutics. Sales data increased from March 2022 to March 2023. Includes both commercial and noncommercial sales. COSELA was first approved February 12, 2021.

PROACTIVE MYELOPROTECTION

COSELA Helps Provide Multilineage Protection Before Chemotherapy Damage

KOL Image and Credentials
We monitor our patients’ blood counts carefully while they are on myelosuppressive chemotherapy for extensive-stage SCLC and, with COSELA, we can see the stabilization of their counts and also in their chemo-induced myelosuppressive symptoms.
Leo Shunyakov, MD
Director of Oncology
Central Care Center
Bolivar, MO
KOL Image and Credentials
My extensive-stage SCLC patients experience fewer hematological side effects with COSELA. I can see that the myeloprotection provided by the therapy makes a big difference in the reduction of chemotherapy-induced myelosuppression.
Abdur Shakir, MD
Director
Sarah Bush Lincoln Regional Cancer Center
Mattoon, IL
COSELA MOA Graphic

GET MORE DETAILS ABOUT
COSELA’S MOA

Get More Details

MULTILINEAGE MYELOPROTECTION BEFORE STARTING CHEMOTHERAPY

Clinical Efficacy Data for Studies With 1st-line E/P/A or E/P, and 2nd- or 3rd-line Topotecan Regimens in ES-SCLC

KOL Image and Credentials
In general, I see a reduction in the need for dose delays and dose reductions in my extensive-stage SCLC patients who have received COSELA. This can help them stay on their treatment plan.
Leo Shunyakov, MD
Director of Oncology
Central Care Center
Bolivar, MO
KOL Image and Credentials
The pivotal study data on reductions in severe thrombocytopenia are interesting to me because we don’t really have a treatment right now to proactively address thrombocytopenia and help reduce the need for platelet transfusions.
Abdur Shakir, MD
Director
Sarah Bush Lincoln Regional Cancer Center
Mattoon, IL

SEE PIVOTAL STUDY DATA

See the Data
Data are from the induction phase. P  values are raw one-sided or multiplicity-adjusted. *Multiplicity-adjusted P  value. (All other P  values are raw one-sided.)
†Adjusted relative risk (aRR) 0.038 (95% CI, 0.008, 0.195)
‡Mean difference -3.6 (95% CI, -4.9, -2.3)
§aRR 0.663 (95% CI, 0.336, 1.310)
‖aRR 0.642 (95% CI, 0.294, 1.404)
aRR 0.053 (95% CI, 0.008, 0.356)
#Results for platelet endpoints including incidence of Grade 3/4 thrombocytopenia and platelet transfusions were not consistent across COSELA clinical trials.

AE, adverse event; E/P, etoposide and carboplatin; E/P/A, etoposide, carboplatin, and atezolizumab; ESA, erythropoiesis-stimulating agents; FN, febrile neutropenia; G-CSF, granulocyte colony-stimulating factors; RBC, red blood cell; SN, severe neutropenia.

REVIEW THE PATIENT-REPORTED OUTCOMES WITH COSELA

See the Data
KOL Image and Credentials
We monitor our patients carefully while they are on chemotherapy and we haven’t seen any big differences in the side effect profile of COSELA compared to what we see with chemotherapy alone except for the reduction in hematologic adverse events.
Leo Shunyakov, MD
Director of Oncology
Central Care Center
Bolivar, MO
KOL Image and Credentials
Hematological adverse events are pretty common in patients treated with carboplatin/ etoposide- or topotecan-containing regimens for extensive-stage SCLC. Having a safe option to proactively help reduce these side effects is a game-changer for me.
Abdur Shakir, MD
Director
Sarah Bush Lincoln Regional Cancer Center
Mattoon, IL
COSELA Adverse Reaction Chart COSELA Adverse Reaction Chart Laboratory-related adverse reactions reported in this table represent a combined analysis of laboratory parameters and any reported laboratory-related adverse reactions. aGraded per NCI CTCAE v4 .03x. bHypocalcemia=calcium decreased (lab) or treatment-emergent adverse event (TEAE) preferred term ‘Hypocalcemia.’ cHypokalemia=potassium decreased (lab) or TEAE preferred terms ‘Hypokalemia,’ ‘Blood potassium decreased.’ dHypophosphatemia=phosphate decreased (lab) or TEAE preferred terms ‘Hypophosphatemia,’ ‘Blood phosphorus decreased.’ eAspartate aminotransferase increased=aspartate aminotransferase increased (lab) or TEAE preferred term ‘Blood aspartate aminotransferase increased.’
COSELA Hematologic Safety Data Graph

SEE THE HEMATOLOGIC SAFETY
DATA FROM TRIALS OF COSELA

See the Data

COSELA IS ADMINISTERED PRIOR TO CHEMOTHERAPY

Dosed first time, every time with chemotherapy

KOL Image and Credentials
Our oncology team has had no trouble adding the additional infusion to the treatment regimen for our extensive-stage SCLC patients and the overall results we have seen encourage me to continue using COSELA.
Leo Shunyakov, MD
Director of Oncology
Central Care Center
Bolivar, MO
KOL Image and Credentials
The dosing is straightforward for COSELA, and my patients understand the need for the additional infusion prior to their chemotherapy.
Abdur Shakir, MD
Director
Sarah Bush Lincoln Regional Cancer Center
Mattoon, IL
COSELA Sample Infusion Schedule Image
* Upon completion of infusion of diluted COSELA solution, the infusion line/cannula MUST be flushed with at least 20 mL sterile 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
 † COSELA can be given within 4 hours before chemotherapy.

LEARN MORE ABOUT DOSING,
PREPARATION, AND
ADMINISTRATION OF COSELA

Learn More
*Upon completion of infusion of diluted COSELA solution, the infusion line/cannula MUST be flushed with at least 20 mL sterile 5% Dextrose Injection, USP or 0.9% Sodium Chloride Injection, USP.
 †COSELA can be given within 4 hours before chemotherapy.