Research Progress And Future Questions
After the 2020 approval of the combination of pembrolizumab and chemotherapy for advanced triple-negative breast cancer, FDA approved the combination therapy for people with early-stage disease in 2021.
That approval was based on results from a different trial, KEYNOTE-522. In that study, patients with high-risk, early-stage triple-negative breast cancer benefited from pembrolizumab given with chemotherapy before surgery, and then continued as a single agent as an additional, or adjuvant, treatment after surgery.
This is an exciting time for research on triple-negative breast cancer, said Dr. Lee. We have now seen a benefit from an immune checkpoint inhibitor and chemotherapy in a subgroup of patients in both the advanced and early stages of the disease.
Dr. Lee cautioned, however, that more than half of all patients with triple-negative breast cancer have PD-L1 combined positive scores of less than 10, so more work is needed to find effective treatments for these patients.
In his editorial, Dr. Pivot noted that people diagnosed with triple-negative breast cancer are not a homogeneous group. Future studies, he added, will try to identify which individuals are more or less likely to benefit from pembrolizumab.
Fda Approves Neoadjuvant Pembrolizumab Combination For Early Tnbc Indication
Based on results of the KEYNOTE-522 trial, the FDA approved pembrolizumab, the first immunotherapy for this indication, plus chemotherapy as neoadjuvant treatment for patients with early-stage triple-negative breast cancer.
The FDA granted approval to the supplemental biologics license application for pembrolizumab as neoadjuvant therapy for patients with high-risk early-stage triple-negative breast cancer when given in combination with chemotherapy followed by single-agent use after surgery, according to the company responsible for the PD-1 inhibitor, Merck.1
This decision by the FDA was supported by data from the phase 3 KEYNOTE-522 trial which examined the neoadjuvant regimen in the indicated patient population versus matched placebo and demonstrated a statistically significant event-free survival benefit with active versus control therapy.
Even when TNBC is diagnosed early, 30% to 40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery, Joyce OShaughnessy, MD, chair of Breast Cancer Research at Baylor University Medical Center of Texas Oncology, U.S. Oncology in Dallas, Texas, said in a press release. Therefore, there is a high unmet need for new treatment options. Todays approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage TNBC.
Nice Allows Immunotherapy Treatment For Small Group Of Patients With Advanced Triple Negative Breast Cancer
The National Institute for Health and Care Excellence has now ruled that pembrolizumab plus chemotherapy should be available as a treatment option for a limited group of patients with advanced triple negative breast cancer.1
In March 2022 NICE published draft guidance that said the immunotherapy treatment was not a cost effective use of resources.2
Pembrolizumab, which is given by injection every three weeks, is a type of immunotherapy that works by blocking the protein PD-L1 which is produced in larger amounts on cancerous cells than normal cells. By blocking PD-L1 it helps the persons own immune cells to attack
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Tecentriq Combination Improves Survival In Advanced Tnbc
Tecentriq when combined with Abraxane in women with advanced TNBC produced an anti-cancer response in 70.8% of patients. The combination of Tecentriq and Abraxane improved average survival duration from 15.5 to 25 months among patients with PD-L1positive tumors compared to Abraxane alone, leading to accelerated FDA approval.8,9
The combination of Tecentriq immunotherapy and chemotherapy improved survival of women with TNBC as evidenced by the results from the IMpassion 130 clinical trial.1-3 The results of the IMpassion131 clinical trail released in August 2020 however were disappointing – Tecentriq when combined with paclitaxel was no better than paclitaxel alone.5 The FDA alerted health care professionals and oncology researchers that paclitaxel did not significantly reduce the risk for cancer progression or death among PD-L1-positive patients with previously untreated inoperable locally advanced or metastatic triple-negative breast cancer. Health care professionals should not replace nab-paclitaxel with paclitaxel in clinical practice, according to the alert.13-16
Over 900 women with previously untreated advanced TNBC were enrolled on the IMpassion130 clinical trial and treated with Nab Paclitaxel chemotherapy with or without Tecentriq immunotherapy and directly compared.13
New Treatments Needed For Advanced Triple
Conventional chemotherapy drugs have not been effective against triple-negative breast cancer, and new treatment options are needed, said Jung-Min Lee, M.D., of the Womens Malignancies Branch in NCIs Center for Cancer Research.
In the KEYNOTE-355 trial, 847 patients with advanced triple-negative breast cancer were randomly assigned to receive chemotherapy plus placebo or chemotherapy plus pembrolizumab.
The study assessed the amount of time before the disease worsened and overall survival in all patients, in those with PD-L1 combined positive scores of 1 or more, and in those with combined positive scores of 10 or more. The trial was funded by Merck, the manufacturer of pembrolizumab.
The PD-L1 combined positive score is essentially a measure of the extent to which cells in a tumor produce PD-L1, the immune checkpoint protein that pembrolizumab targets. By blocking immune checkpoints, pembrolizumab and other immune checkpoint inhibitors unleash the immune system against cancer cells.
The incidence of treatment-related side effects, including serious side effects, was similar between the two groups of patients in the study.
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Fda Approves Keytruda Plus Chemo For Triple
First-line treatment with immunotherapy and a chemotherapy regimen extended progression-free survival by 35%.
The Food and Drug Administration has granted accelerated approval of the checkpoint inhibitor Keytruda in combination with chemotherapy for the treatment of people with locally recurrent or metastatic triple-negative breast cancer whose tumors express a biomarker associated with better response.
Breast cancer is classified according to the types of receptors it expresses. A majority of breast tumors carry estrogen or progesterone receptors and can be treated with hormone therapy. Others express a receptor called HER2 and can be treated with HER2 inhibitors such as Herceptin . Triple-negative breast cancer does not express any of these receptors and is harder to treat. Approximately 15% to 20% of patients with breast cancer are diagnosed with triple-negative breast cancer, which is a difficult-to-treat and aggressive cancer, Hope Rugo, MD, of the University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, said in a Merck press release. The approval of Keytruda in combination with chemotherapy gives physicians an important new option for appropriate patients.
Breast cancer is generally considered a cold tumor that doesnt respond very well to immunotherapy. But combining checkpoint inhibitors with chemotherapy may help make tumors more susceptible.
for full prescribing information for Keytruda.
to learn more about breast cancer.
Fda Approves Keytruda/chemo For Triple
The approval of the immunotherapy agent has the potential to change the treatment paradigm in high-risk, early-stage TNBC.
The Food and Drug Administration approved Keytruda plus chemotherapy for the treatment of patients with high-risk, early-stage triple-negative breast cancer , according to Merck, the manufacturer of the immunotherapy agent.
Per the approval, the Keytruda/chemotherapy regimen should be given before breast cancer surgery and then the anti-PD-1 therapy should be given alone after surgery .
We are proud to offer a new treatment option for patients faced with this challenging cancer. This neoadjuvant and adjuvant combination with Keytruda is the first immunotherapy regimen to be approved in high-risk early-stage TNBC, marking a meaningful milestone for the breast cancer community, Dr. Vicki Goodman, vice president of clinical research at Merck Research Laboratories, said in a press release.
The approval is based on findings from the KEYNOTE-522 clinical trial, which demonstrated that Keytruda plus chemotherapy before surgery and continued as a single agent after surgery significantly improved event-free survival compared to just neoadjuvant chemotherapy. Additionally, trial results showed that the newly approved regimen resulted in a 37% decrease in the risk of disease progression before definitive surgery, local or distant recurrence, another cancer or any-cause death.
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Keytruda + Chemotherapy Is A Treatment Option That May Help You Fight Certain Types Of Advanced Tnbc
Cancer was the last word you wanted to hear. With KEYTRUDA + chemotherapy, you have a treatment option that may help fight certain types of advanced TNBC, which is when your breast cancer has returned and cannot be removed by surgery or has spread .
A clinical trial compared women with certain types of advanced TNBC who received KEYTRUDA in combination with chemotherapy with those who received chemotherapy alone.
Among the 847 women in this trial, 323 had tumors that tested positive for PD-L1 with a combined positive score of 10 or more . Of those women, 220 received 200 mg of KEYTRUDA every 3 weeks with chemotherapy and 103 received chemotherapy alone. The chemotherapies used were paclitaxel, or paclitaxel protein-bound, or gemcitabine and carboplatin.
This biomarker test for PD-L1, CPS, evaluates the personâs likelihood of responding to KEYTRUDAâa programmed death receptor 1 inhibitor.
PD-L1 = programmed death ligand 1.
The clinical trial enrolled:
- Women with TNBC which returned and could not be removed by surgery or had spread , who had not been previously treated with chemotherapy for metastatic cancer, and
- Whose tumors were tested for PD-L1. This information helps doctors decide what cancer treatment is right for you
What To Expect When Taking Keytruda
Keytruda is given as a 30-minute infusion, every 3 or 6 weeks, depending on the dose given at each infusion. The Keytruda infusion is given before the chemotherapy infusion. If you are receiving Keytruda for metastatic or unresectable locally advanced triple-negative breast cancer, you may continue treatment with Keytruda and chemotherapy for up to 2 years, unless the cancer grows or you develop unacceptable side effects.
Women who are pregnant or planning to get pregnant should not be given Keytruda. Keytruda can cause embryo death and birth defects. Its important that you dont get pregnant while youre getting Keytruda you must use effective birth control.
Keytruda also can cause other serious side effects, including:
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Do I Need Genetic Counseling And Testing
Your doctor may recommend that you see a genetic counselor. Thats someone who talks to you about any history of cancer in your family to find out if you have a higher risk for getting breast cancer. For example, people of Ashkenazi Jewish heritage have a higher risk of inherited genetic changes that may cause breast cancers, including triple-negative breast cancer. The counselor may recommend that you get a genetic test.
If you have a higher risk of getting breast cancer, your doctor may talk about ways to manage your risk. You may also have a higher risk of getting other cancers such as ovarian cancer, and your family may have a higher risk. Thats something you would talk with the genetic counselor about.
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What Are The Odds Of Surviving Triple
What are the odds of surviving triple-negative breast cancer?
|All stages combined||77%|
Where does triple-negative breast cancer usually spread to? It has spread to distant organs or to lymph nodes far from the breast. The most common sites of spread are the bone, liver, brain or lung.
How long can you live with triple negative? In general, about 91% of all women with triple-negative breast cancer are still alive 5 years after diagnosis. If the cancer has spread to the lymph nodes near the breast the 5 year relative survival rate is about 65%. If the cancer has spread to distant places, the 5 year relative survival rate is 12%.
Can you survive stage 3 triple-negative breast cancer? According to the American Cancer Society, if any type of breast cancer is found to be stage 1, the 5-year survival rate is nearly 100%. Stage 2 breast cancer survival is about 93%, stage 3 is 72%, and metastasized or grade 4 breast cancer has about a 22% chance of survival.
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Nice Says No To Keytruda In Triple
There isnt enough evidence to support the use of Merck & Co/MSDs Keytruda in combination with chemotherapy as a first-line treatment for advanced triple negative breast cancer, according to the UK cost effectiveness watchdog NICE.
In draft guidance, the agency has said that while Keytruda added to chemotherapy is more effective than chemo alone. Its long-term benefits are uncertain.
Moreover, NICE says there is no data to compare Keytruda plus chemo to the combination of Roches rival cancer immunotherapy Tecentriq and chemo which was previously recommended for NHS use in these patients in May 2020.
For Keytruda, the cost-effectiveness estimates are higher than NICE normally considers an acceptable use of NHS resources, said the agency.
Somewhat unusually, it said it would also like to see more information from the company about the comparison between pembrolizumab plus chemotherapy with atezolizumab plus chemotherapy.
Tecentriq was also turned down by NICE in draft guidance, before eventually getting a green light in TNBC after Roche agreed a confidential discount on the drugs list price.
TNBC is a particularly aggressive form of breast cancer, with few treatment options aside from surgery, radiotherapy and chemotherapy. One issue is that TNBC tumours lack oestrogen, progesterone and HER2 receptors, so it isnt possible to treat the disease with drugs that target these biomarkers.
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Imfinzi Effective As Neoadjuvant Treatment For Stage I
The GeparNuevo clinical trial evaluated whether the addition of Imfinzi , a PD-L1 antibody, to neoadjuvant chemotherapy would increase the rate of pathologic complete response in patients with early-stage TNBC. In this trial patients with stage I-III TNBC were treated with durvalumab or placebo, in combination with nab-paclitaxel plus epirubicin and cyclophosphamide chemotherapy. A numerical increase in the pCR rate was initially reported with durvalumab compared to placebo . At the 2021 Annual Meeting of the American Society of Clinical Oncology, the investigators reported the results of longer-term outcomes. At a median follow-up of 43.7 months 85.6% of patients treated with durvalumab survived cancer free compared to 77.2% of those not receiving durvalumab. The addition of durvalumab also significantly improved the 3 year overall survival rate from 83% to 95%. Longer survival with durvalumab was observed regardless of PD-L1 status, stromal TILs, stage, age or pCR.20
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Fda Approves Keytruda For High
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The FDA approved pembrolizumab for treatment of patients with high-risk, early-stage triple-negative breast cancer.
The approval applies to use of pembrolizumab an anti-PD-1 therapy with chemotherapy in the neoadjuvant setting, then as monotherapy in the adjuvant setting.
Even when triple-negative breast cancer is diagnosed early, 30% to 40% of patients will suffer cancer recurrence after standard neoadjuvant chemotherapy and surgery, Joyce OShaughnessy, MD, chair of breast cancer research at Baylor University Medical Center and Texas Oncology, said in a Merck-issued press release. Therefore, there is a high unmet need for new treatment options. approval is very welcome news and has the potential to change the treatment paradigm by now including an immunotherapy as part of the regimen for patients with high-risk early-stage triple-negative breast cancer.
The FDA based approval on results of the randomized phase 3 KEYNOTE-522 trial, which included 1,174 adults with previously untreated, nonmetastatic, centrally confirmed triple-negative breast cancer. All patients had stage T1c N1-2 or T2-4 N0-2 disease.
Researchers assigned 784 patients to 200 mg pembrolizumab every 3 weeks in combination with neoadjuvant chemotherapy . The other 390 patients chemotherapy plus placebo.
Fda Approves Keytruda For Treatment Of Patients With High
This KEYTRUDA Combination Is the First Immunotherapy Regimen Approved for High-Risk Early-Stage Triple-Negative Breast Cancer
KEYTRUDA Is Now Approved in the US for 30 Indications
KENILWORTH, N.J.—-Merck , known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Mercks anti-PD-1 therapy, for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery, based on the Phase 3 KEYNOTE-522 trial. TNBC is an aggressive type of breast cancer with an increased risk for disease recurrence. KEYNOTE-522 showed that KEYTRUDA in combination with chemotherapy before surgery and continued as a single agent after surgery significantly prolonged event-free survival versus the same neoadjuvant chemotherapy regimens alone in patients with previously untreated stage II or stage III TNBC there was a 37% reduction in the risk of disease progression that precluded definitive surgery, a local/distant recurrence, a second primary cancer, or death from any cause . With this approval, KEYTRUDA is now approved in the U.S. for 30 indications.
Merck is rapidly advancing a broad portfolio in gynecologic and breast cancers with an extensive clinical development program for KEYTRUDA and several other investigational and approved medicines across these areas.
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Keytruda Combo Approved For High
The Food and Drug Administration has approved Keytruda® for treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.
The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 KEYNOTE-522 trial , which included 1174 patients with newly diagnosed previously untreated high-risk early-stage TNBC. Patients were randomly assigned 2:1 to receive either pembrolizumab plus chemotherapy or placebo plus chemotherapy .
The coprimary endpoints were pathological complete response rate, defined as the absence of invasive cancer in the breast and lymph nodes as assessed by a blinded local pathologist at the time of definitive surgery, and event-free survival , defined as the time from randomization to the first occurrence of any of the following events: progression of disease that precludes definitive surgery, local or distant recurrence, second primary malignancy, or death due to any cause.
Results showed a pCR rate of 63% for the pembrolizumab plus chemotherapy arm compared with 55.6% for the placebo arm . The proportion of patients who experienced an EFS event was 16% in the pembrolizumab plus chemotherapy arm vs 24% in the placebo arm . At the protocols prespecified interim analysis, the overall survival data was not mature with 45% of the required events for the final analysis.