Recently Presented Long-Term Progression-Free Survival Data in Multiple Myeloma

Posted: December 20, 2017 | Word Count: 1,547
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Multiple myeloma is one of the most common types of blood cancer, with more than 30,000 Americans expected to be diagnosed this year.1 Formed by malignant plasma cells that are typically located within bone marrow, multiple myeloma often causes no symptoms until an advanced stage.2 Despite advances in treatment over the last decade, less than half of patients survive longer than five years after diagnosis.1

There have been numerous advancements in multiple myeloma research and treatment options that have improved the overall prognosis of the disease. Some of these advancements involve exploring potential ways to work directly with patients’ immune systems to fight multiple myeloma, an area of research known as Immuno-Oncology (I-O).3,4

Recently, research looking at follow-up data for relapsed or refractory multiple myeloma I-O treatment, Empliciti (elotuzumab), was presented at the 22nd Congress of the European Hematology Association. Empliciti is a prescription medicine used to treat multiple myeloma in combination with the medicines lenalidomide and dexamethasone in people who have received one to three prior treatments for their multiple myeloma.5 It is not known if Empliciti is safe and effective in children.

Empliciti in combination with lenalidomide and dexamethasone may cause the following serious side effects: infusion reactions, infections, risk of developing new cancers (malignancies) and liver problems. There are also other serious risks associated with lenalidomide to females and males of reproductive potential, including possible serious birth defects or death of an unborn baby, and specific requirements regarding birth control, pregnancy testing and blood and/or sperm donation.5 For more information, please read Important Safety Information below. Patients’ healthcare team will work with them to manage any side effects they may experience throughout treatment with Empliciti.

In the clinical trial of 646 multiple myeloma patients who had received one to three prior treatments (in which 321 received Empliciti with lenalidomide and dexamethasone, and 325 received lenalidomide and dexamethasone alone), more people in the Empliciti treatment arm were living with their disease under control after four years of follow-up. Empliciti, in combination with lenalidomide and dexamethasone in patients who had received one to three prior therapies, is the only therapy that demonstrated a long-term benefit in progression-free survival that was maintained through four years versus lenalidomide and dexamethasone alone.6

After at least two years of follow-up, people who received Empliciti with lenalidomide and dexamethasone were at 30% less risk of their disease progressing or passing away from any cause, compared with people taking lenalidomide and dexamethasone alone. After at least four years of follow-up, results were similar.

At the four-year follow-up, there was a 21% chance that people taking Empliciti with lenalidomide and dexamethasone were still living with their disease under control, compared with a 14% chance for people taking lenalidomide and dexamethasone alone.

The study was designed to look at progression-free survival at two years. Progression-free survival is the length of time during and after treatment of a disease that a patient lives with the disease, but it does not get worse.

The study was also designed to look at the overall response rate. Overall response rate is the percentage of patients who responded to treatment—for example, patients whose level of M protein was lowered by a certain amount. Overall response rates include complete response, very good partial response and partial response.

The main analysis for progression-free survival took place at two years. Patients still benefiting from treatment continued in the study, and a follow-up analysis was done at four years. Both evaluations were based on the entire population of 646 patients.

At two years, there was a 41% chance that people taking Empliciti with lenalidomide and dexamethasone were living with their disease under control, compared with a 27% chance for people taking lenalidomide and dexamethasone alone.

Also in this study, about four out of five people (78.5%) responded to treatment with Empliciti with lenalidomide and dexamethasone, compared to about two out of three people (65.5%) taking lenalidomide and dexamethasone alone.

The most common side effects of Empliciti in combination with lenalidomide and dexamethasone and lenalidomide and dexamethasone alone, respectively, were fatigue (61.6%, 51.7%); diarrhea (46.9%, 36.0%); fever (37.4%, 24.6%); constipation (35.5%, 27.1%); cough (34.3%, 18.9%); numbness, weakness, tingling, or burning pain in your arms or legs (26.7%, 20.8%); sore throat or runny nose (24.5%, 19.2%); upper respiratory tract infection (22.6%, 17.4%); decreased appetite (20.8%, 12.6%); and pneumonia (20.1%, 14.2%). These side effect rates were determined after the typical patient had received about 19 cycles of Empliciti with lenalidomide and dexamethasone or 14 cycles of lenalidomide and dexamethasone alone. These side effects were experienced by at least 20% of patients receiving Empliciti with lenalidomide and dexamethasone and at a 5% or greater rate than patients who took lenalidomide and dexamethasone alone.

The percentage of patients who stopped treatment due to side effects was similar for both treatment groups (6.0% for patients who received Empliciti with lenalidomide and dexamethasone and 6.3% for patients who received lenalidomide and dexamethasone alone).6

Researchers across the globe are continuing research into activating the body’s immune system to fight cancers, both hematologic and solid tumors, with the goal of providing more effective treatment options. The results of this follow-up analysis are an important step toward progress in supporting relapsed or refractory multiple myeloma patients.6

Empliciti is available by prescription only in 300 mg and 400 mg vials for injection for intravenous use. Empliciti may not work for all patients, and individual results may vary.

WHAT IS EMPLICITI™ (elotuzumab)?

EMPLICITI is a prescription medicine used to treat multiple myeloma in combination with the medicines REVLIMID® (lenalidomide) and dexamethasone in people who have received one to three prior treatments for their multiple myeloma.

It is not known if EMPLICITI is safe and effective in children.

IMPORTANT SAFETY INFORMATION

EMPLICITI is used in combination with REVLIMID and dexamethasone. It is important to remember that the safety information for these medications also applies to EMPLICITI combination therapy.

Before you receive EMPLICITI, tell your healthcare provider about all of your medical conditions, including if you:

  • have an infection
  • are pregnant or plan to become pregnant. It is not known if EMPLICITI may harm your unborn baby. However, REVLIMID may cause birth defects or death of an unborn baby.
    • Before receiving EMPLICITI with REVLIMID and dexamethasone, females and males must agree to the instructions in the REVLIMID REMS® program. This program has specific requirements about birth control (contraception), pregnancy testing, blood donation, and sperm donation that you need to know. Talk to your healthcare provider to learn more about REVLIMID.
  • are breastfeeding or plan to breastfeed. It is not known if EMPLICITI passes into breast milk. You should not breastfeed during treatment with EMPLICITI and REVLIMID and dexamethasone.
  • Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Serious side effects that can occur with EMPLICITI treatment are:

Infusion reactions

  • Infusion reactions can happen during your infusion or within 24 hours after your infusion of EMPLICITI. Your healthcare provider will give you medicines before each infusion of EMPLICITI to help reduce the risk of an infusion reaction.
  • If you have an infusion reaction while receiving EMPLICITI, your healthcare provider will slow or stop your infusion and treat your reaction. If you have a severe infusion reaction your healthcare provider may stop your treatment completely.
  • Tell your healthcare provider or get medical help right away if you have any of these symptoms after your infusion with EMPLICITI: fever, chills, rash, trouble breathing, dizziness, light-headedness.

Infections

  • Those receiving EMPLICITI with REVLIMID and dexamethasone may develop infections; some can be serious.
  • Tell your healthcare provider right away if you have any of the signs and symptoms of an infection, including: fever, flu-like symptoms, cough, shortness of breath, burning with urination, or a painful skin rash.

Risk of new cancers (malignancies)

  • Those receiving EMPLICITI with REVLIMID and dexamethasone have a risk of developing new cancers.
  • Talk with your healthcare provider about your risk of developing new cancers if you receive EMPLICITI.
  • Your healthcare provider will check you for new cancers during your treatment with EMPLICITI.

Liver problems

  • EMPLICITI may cause liver problems. Your healthcare provider will do blood tests to check your liver during treatment with EMPLICITI.
  • Tell your healthcare provider if you have signs and symptoms of liver problems, including: tiredness, weakness, loss of appetite, yellowing of your skin or eyes, color changes in your stools, confusion, or swelling of the stomach area.

The most common side effects of EMPLICITI include:

  • fatigue
  • diarrhea
  • fever
  • constipation
  • cough
  • numbness, weakness, tingling, or burning pain in your arms or legs
  • sore throat or runny nose
  • upper respiratory tract infection
  • decreased appetite
  • pneumonia

These are not all of the possible side effects of EMPLICITI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Please read Patient Information in the full Prescribing Information: http://packageinserts.bms.com/pi/pi_empliciti.pdf.

References

  1. National Cancer Institute. Surveillance, Epidemiology, and End Results Program Stat Fact Sheets: Myeloma. 2017.
  2. American Cancer Society. What Is Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed September 6, 2017.
  3. Eggermont A, Finn O. Advances in Immuno-oncology. Annals of Oncology. 2012.
  4. American Cancer Society. Chemotherapy and Other Drugs for Multiple Myeloma. https://www.cancer.org/cancer/multiple-myeloma/treating/chemotherapy.html. Accessed September 6, 2017.
  5. Empliciti. Prescribing Information. Empliciti. U.S. Product Information. Last updated: May 12, 2017. Princeton, NJ: Bristol-Myers Squibb Company.
  6. Dimonopoulos MA, Lonial S, White D. Phase 3 ELOQUENT-2 Study: Extended 4-Year Follow-Up of Elotuzumab Plus Lenalidomide/Dexamethasone vs. Lenalidomide/Dexamethasone in Relapsed/Refractory Multiple Myeloma. European Hematology Association Annual Meeting. 2017.

EMPLICITI and the related logo are trademarks of Bristol-Myers Squibb Company. REVLIMID and REVLIMID REMS are registered trademarks of Celgene Corporation.

© 2017 Bristol-Myers Squibb Company. All rights reserved. 689US1702801-02-01 12/17

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