Talvey is a type of new cancer treatment called immunotherapy. Immunotherapy works by using the body's immune system to fight cancer cells. Talvey is a type of immunotherapy called a bispecific antibody, which is designed to help the immune system fight a blood cancer called multiple myeloma.
How Does Talvey Work for Multiple Myeloma?
Talvey is a special type of molecule that can attach to two different types of cells. This is called a bispecific antibody. It attaches to GPRC5D proteins on myeloma cells (and other cells), and to CD3 proteins on immune cells called T cells. This activates the T cells, makes them multiply, and helps them release chemicals that destroy the myeloma cells.
What Kind of Myeloma Does Talvey Treat?
Talvey treats multiple myeloma that has come back after previous therapy (relapsed) or did not go away after previous therapy (refractory) in people who have received at least four different types of treatment.
How Will I Get Talvey?
Talvey is given as a subcutaneous injection. It will be given to you by a health care provider in a health care setting. Talvey is dosed on a “step-up” dosing schedule. Your dosage of Talvey for the first week will be as follows:
- 0.01 mg/kg on day 1
- 0.06 mg/kg on day 4
- 0.4 mg/kg on day 7
After your first three doses you will either receive one more dose of 0.8 mg/kg on day 10 followed by 0.8 mg/kg once every two weeks, or you will receive Talvey 0.4 mg/kg once every week. Your health care provider may stop Talvey or adjust your dose if your cancer gets worse (progresses) or you have side effects that prevent you from tolerating the medicine.
How Well Does Talvey Work for Multiple Myeloma?
Talvey was studied in people who had relapsed or refractory myeloma. This study included people who had received at least three prior types of treatment or could not get therapy because of side effects. People in this study got either 0.4 mg/kg once weekly or 0.8 mg/kg once every two weeks of Talvey. This study looked at overall response rate (ORR), which measured the percentage of people who had a response to therapy. It also looked at how long it took people to respond (time to response), how long the response lasted (duration of response), and how long people stayed alive without progression of their cancer (progression-free survival). There were 297 people in this study; 30 received the 0.4 mg/kg weekly dose and 44 received 0.8 mg/kg every two weeks. The other 223 people received different doses that were not included in the study endpoints. The ages ranged from 46 to 84 years old, with the median being about 63. There were more men than women in the weekly group (63%), and about half were men in the every-two-week group. In this study, 81% of people were white, 10% were African-American, 4% were Asian, and 5% were "other" or not reported.
The ORR for people who got the 0.4 mg/kg dose was 70% and for people who got the 0.8 mg/kg dose was 64%. It took people in the 0.4 mg/kg group 0.9 months to respond and that response lasted for 10.2 months. In the 0.8 mg/kg group, people responded in 1.2 months and it lasted 7.8 months. Of the people that had a response, around 48% (10 out of 21) of the people who got 0.4 mg/kg and nearly 68% (19 out of 28) of the people who got 0.8 mg/kg were alive without progression at the end of the study.
Some people in this study were then followed for a total of 24 months to look at long-term outcomes like median ORR, duration of response (dOR), which measured how long their responses lasted, and rate of overall survival (OS). There were three groups for this part of the study. People who never got a therapy like Talvey before received either 0.4mg/kg weekly or 0.8 mg/kg every two weeks, and then people who had received a therapy similar to Talvey in the past got either 0.4 mg/kg weekly or 0.8 mg/kg every two weeks. ORR was 74%, 70%, and 67% for patients in the every week, every two weeks, and the prior therapy group, respectively. The mDOR was 9.5 months for the weekly group and 17.5 months for the every-two-week group. This means that half the people in the weekly group had a response that lasted at least 9.5 months, and half the people in the every-two-week group had a response that lasted at least 17.5 months. About 61% of people in the weekly group and 67% in the every-two-week group were still alive at 24 months. This shows that people continued to have long-term and lasting responses to Talvey.
What Are Some Other Unique Considerations to Be Aware Of?
Talvey can cause a serious side effect called cytokine release syndrome (CRS). CRS happens when your body has an exaggerated reaction to either an infection or immunotherapy. Your body responds by releasing cytokines, and sometimes these cytokines cause fevers and problems in some of your organs. To help reduce the risk of CRS, the dose of Talvey will be gradually increased over your first three doses. You will get your first few doses of Talvey in the hospital, and your health care provider will monitor you for 48 hours after each dose. If you have symptoms of CRS (such as fast heartbeat, trouble breathing, or severe headache) with any doses, you may need to receive your next dose in the hospital. You will get medicines to help prevent CRS. Your health care provider should give you a Talvey Wallet Card, which lists all the symptoms of CRS. You should carry this with you all the time.
Talvey can cause harm to an unborn baby. Your health care provider will discuss options for contraception while you take Talvey. You should use an effective method of birth control while you are receiving Talvey and for three months after your last dose. If you and your partner are or are planning to become pregnant, talk with your health care provider about your options. Talvey may pass into your breast milk if you are breastfeeding. You should not breastfeed while you are getting Talvey and for three months after your last dose.
Talvey may cause other severe side effects such as neurologic problems. Contact your health care provider right away if you experience signs of neurologic problems including dizziness, headache, numbness in hands and feet (peripheral neuropathy), or changes in your mental status.
What Are the Side Effects of Talvey, and How Can I Prevent or Manage Them?
Talvey may cause gastrointestinal (GI) side effects such as nausea, diarrhea, and constipation. Your health care provider may give you certain medicines to prevent these side effects from happening, as well as medicines to treat them if they occur. Eating bland food and smaller meals throughout the day can help with symptoms of nausea. If you experience diarrhea, your health care provider may recommend that you take diarrhea medicine and drink more fluids to avoid losing too much of your body water (dehydration). Drinking more fluids can also help to prevent constipation, as well as eating foods that are high in fiber.
Skin reactions are a common side effect of Talvey. If you develop a rash, you should contact your health care provider. They may recommend creams or antihistamines to help with your rash and itchiness. You may also be given a corticosteroid to treat your rash.
Severe infections can occur while taking Talvey. You can help reduce your risk of developing an infection by washing your hands often and staying away from people with infections, colds, or the flu. If you are at high risk for getting an infection, your health care provider may prescribe a medicine to help prevent infections. You should contact your healthcare provider right away if you develop a fever or any other signs of an infection such as a sore throat or cough.
Talvey may also cause oral toxicity, including dry mouth, trouble swallowing, and stomatitis (inflammation of the mouth). Good dental hygiene such as brushing your teeth several times a day with a soft toothbrush and flossing at least once a day can help prevent mouth sores and dry mouth. If you experience mouth sores, you can use a mixture of baking soda, salt, and warm water to rinse your mouth. Avoiding spicy, acidic, and hard foods such as chips, and eating softer foods instead can help if you have mouth pain. You can try over-the-counter medications that help to numb your mouth sores, or your doctor may give you something to treat your pain if it becomes severe. To help with dry mouth, you can try sucking on ice chips or sugar-free candy, using lubricating lip balm to keep your lips moist, or using a saliva substitute. You may also experience weight loss while taking Talvey. Your health care provider will monitor your weight frequently, but you should contact them if you notice a significant decrease in your weight.
How Do I Know if Talvey Is Working?
Your health care provider will regularly check how well Talvey is working for your cancer through looking at results of tests such as blood tests and CT scans or MRI scans. You may notice improvements within a few weeks to months after starting Talvey. The complete therapeutic effect can take longer, depending on individual factors and disease progression.
How Long Does Talvey Stay in My System?
Talvey remains in the body for several months after the last dose. Regular follow-up is essential to manage any lingering side effects and ensure a smooth transition off the treatment.
