“To keep the body in good health is a duty… otherwise we shall not be able to keep our mind strong and clear.” – Buddha

Enhertu shines as a major hope in the fight against cancer. It’s a new kind of targeted therapy that seeks to help those with HER2-positive cancers. This includes cancers of the breast, stomach, and some other solid tumors.

Daiichi Sankyo and AstraZeneca worked together to create Enhertu. Its impact is huge. The FDA called it a Breakthrough Therapy seven times.

Enhertu is crucial for people with HER2 overexpression. That’s when there’s too much HER2 in tumors. This new therapy is already changing the game for HER2-positive cancers.

Key Takeaways

• Enhertu is a breakthrough targeted therapy for HER2-positive cancers.
• Developed by Daiichi Sankyo and AstraZeneca, it has received multiple FDA Breakthrough Therapy Designations¹.
• HER2 overexpression is observed in 1% to 28% of metastatic solid tumors¹.
• Enhertu offers hope for patients with limited treatment options¹.
• This transformative cancer treatment is making headway in treating various HER2-positive cancers¹.

Introduction to Enhertu

Enhertu is a big step forward in treating HER2-positive metastatic breast cancer. It’s an innovative antibody drug conjugate. This medicine targets cancer cells directly, lessening damage to healthy tissues. It stands as an effective option instead of traditional chemotherapy.

What is Enhertu?

Enhertu focuses on sending chemotherapy straight to cancer cells. This means it hurts fewer healthy tissues. In clinics, it works really well. For example, many patients saw their tumors get smaller by using Enhertu².

People with HER2-positive breast cancer who used Enhertu did better than those using a different medicine. They lived over a year without their cancer getting worse². This was much longer than the folks on the other medicine who only went a few months without progression².

Development Background

Daiichi Sankyo and AstraZeneca worked together to create Enhertu. They wanted to find better treatments for cancers that have too much HER2. Enhertu worked much better than regular chemo. More patients responded well to it, stopping the disease from growing for almost a year³.

For patients with low HER2, Enhertu also did great. It gave them about 10 months without the disease getting worse³.

FDA Approvals

Enhertu has been approved by the FDA for being very effective. In a key trial, it did much better than chemo. Over half of the patients responded well to Enhertu³.

This shows Enhertu is a solid choice. It helps many patients, even those with stomach cancers. In fact, it made tumors smaller in 42% of these patients².

How Enhertu Works

Enhertu is special because it combines a HER2 monoclonal antibody with a cancer-killing payload. It targets HER2-positive cells commonly found in certain breast cancers. By doing this, it makes the treatment more effective against the cancer but spares healthy cells⁴. This approach results in a much bigger shrinkage of tumors, which is a big deal in fighting cancer⁵.

Studies like DESTINY-Breast03 and DESTINY-Breast04 showed great results with Enhertu. In the DESTINY-Breast03 study, 76% of patients saw their cancer controlled after a year. With another cancer treatment, only 34% managed⁵. During the DESTINY-Breast04 study, patients on Enhertu went without their cancer getting worse for nearly twice as long. They had an average of 10 months without any cancer growth, unlike those on normal chemotherapy whose average was only 5 months⁴. Also, 80% of patients treated with Enhertu saw their tumors shrink or disappear⁵.

But, using Enhertu also comes with possible side effects like changes in blood cells and liver issues. Nausea, vomiting, and hair loss are also common⁶. Even with these downsides, Enhertu still delivers more chemotherapy directly to the cancer cells than other treatments⁵. This direct targeting helps more effectively shrink tumors, showing how powerful Enhertu is in cancer care today.

• FDA approved for HER2-positive and HER2-low breast cancers
• Participants lived nearly twice as long without progression in clinical trials⁴
• Tumors shrank in 80% of patients⁵

The accuracy and targeted delivery of chemotherapy through Enhertu promise a new dawn in cancer treatment, ensuring not only effective tumor shrinkage but also the preservation of patients’ quality of life.

Enhertu for HER2-Positive Cancers

Enhertu marks a turning point in treating HER2-positive cancers. It’s a crucial choice for those with breast, gastric, and other solid tumors. These tumors must express HER2. Through clinical trials, Enhertu has shown its worth across various cancer types. This includes cases where treatment options were very few. It’s changing how we fight cancer, offering hope in difficult situations.

HER2-Positive Breast Cancer

Enhertu is making a big difference with metastatic breast cancer that’s HER2-positive. In the DESTINY-Breast06 trial, it led to a major improvement in how long patients went without their cancer progressing. This was compared to standard chemotherapy for those with HR-positive, HER2-low cancer⁷. Now, in more than 60 countries, Enhertu is a top choice for treating patients with these kinds of breast cancers⁷.

HER2-Positive Gastric Cancer

For those with HER2-positive gastric cancer, Enhertu brings new hope. The FDA has approved it for advanced HER2-positive tumors. This reflects its big potential to change the game⁸. Its role in treating HER2-positive gastric cancers confirms its leading position in cancer care⁷. The approval has opened up new treatment avenues, improving outcomes for patients worldwide.

Other HER2-Positive Solid Tumors

Enhertu isn’t just for breast and gastric cancers. It’s also proving valuable for other HER2-positive solid tumors. The DESTINY-PanTumor02 trial showed that patients responded well to Enhertu. They had a confirmed ORR of 51.4% and a DoR of 19.4 months on average⁹. It’s also working on cancers of the salivary gland, biliary tract, lung, and colorectal areas⁸. Each approval for different tumor types shows Enhertu’s vast potential. This makes it a key therapy, standing out in its class of treatments⁸.

Enhertu in Clinical Trials

The Enhertu clinical trials have changed how we fight cancer, especially in HER2-targetable cases. In Trial 1, Enhertu had an impressive ORR of 60.3%. This included a 4.3% CR and a 56.0% PR¹⁰. This shows how effective Enhertu is. The DOR was also long, lasting about 14.8 months¹⁰.

The DESTINY studies are key. They looked at trials like DESTINY-PanTumor02, with 267 people from North America, Asia, and Europe¹¹. They focused on the ORR and other important factors like safety and OS¹¹. Early results showed PFS and OS benefits to the patients¹¹.

In the Phase III DESTINY-Breast03 trial, Enhertu showed good results. It treated patients with HER2-positive breast cancer. The results were similar among different demographics and across different ages. These trials have shown Enhertu is a versatile cancer treatment.

The current phase 3 Destiny-Breast05 trial looks at Enhertu against T-DM1. It’s for patients with high-risk HER2-positive early breast cancer. This trial plans to include up to 1,600 patients from about 400 sites worldwide¹². Enhertu’s breakthrough designation and its U.S. and Japan approvals show its important role in cancer research¹².

ENHERTU comes from Daiichi Sankyo and AstraZeneca working together. It’s part of a big worldwide effort to test its impact on different HER2 cancers¹². The DESTINY studies and other tests have really highlighted Enhertu’s role in improving outcomes for patients. It’s a major advance in cancer research.

Enhertu Side Effects: What You Need to Know

Enhertu is very effective in fighting multiple types of cancers. But, it’s important to know the side effects it can have. This knowledge helps in handling the effects better.

Common Side Effects

It’s common to feel sick, tired, or lose hair when taking Enhertu. People with HER2-positive cancer might also have stomach issues like constipation or not wanting to eat¹³¹⁴.

Serious Side Effects

Some side effects of Enhertu need quick medical help. A big worry is ILD, a lung disease that can be very serious¹³. It can also affect your heart and how well your body fights off infections¹³¹⁵.

It’s vital to watch for a cough, hard to breathe feeling, or fever while on Enhertu¹³¹⁵.

Managing Side Effects

To deal with Enhertu’s side effects, stay ahead with health checks. Keeping an eye on your blood and heart can catch problems early. If you had lung or heart issues before, talk to your doctor first¹³.

Doctors need to watch out for side effects and act fast. This is very crucial, especially for serious problems like ILD or heart issues¹³.

Common Side Effects	Serious Side Effects	Management Strategies
Nausea, anemia, fatigue, hair loss	Interstitial lung disease (ILD), reduced heart function, low white blood cell counts	Regular monitoring, blood tests, immediate medical consultation
Constipation, decreased appetite	Potential for severe allergic reactions	Proactive discussions with healthcare providers, early intervention

Enhertu Dosage and Administration

Knowing the right Enhertu dosage is key for its success. It’s used to treat various cancers. Doctors may give 5.4 mg/kg for diseases like HER2-positive metastatic breast cancer. This is done every three weeks through an IV. For stomach cancer, the dose is a bit higher, at 6.4 mg/kg¹⁶.

If there are side effects, the dosage might change. For some cancers, the dose can be lower than the starting dose. This change is to help patients better handle the medicine. If someone has lung problems, doctors might stop the Enhertu and give other medicines too¹⁷¹⁸.

Preparing and giving this treatment the right way matters a lot. The medicine needs to be mixed carefully. First, it’s mixed with special water. Then, it’s added to a bag with another liquid. This is all to make sure the medicine is safe to use¹⁷¹⁶.

After mixing, the treatment must be kept in certain conditions. It can be in the fridge or at room temperature. But, it should never get too cold or freeze. Also, it must be kept away from direct light¹⁷.

The most common side effects are things like feeling sick, tired, and throwing up. These happen to many patients. Doctors closely watch these problems and may adjust the treatment if needed¹⁸.

Condition	Recommended Dosage	Frequency
HER2-Positive Breast Cancer	5.4 mg/kg	Every 3 weeks16
HER2-Low Breast Cancer	5.4 mg/kg	Every 3 weeks17
NSCLC	5.4 mg/kg	Every 3 weeks17
Gastric Cancer	6.4 mg/kg	Every 3 weeks17
HER2-Positive Solid Tumors	5.4 mg/kg	Every 3 weeks17

Healthcare workers must follow the enhertu prescribing information very carefully. This is the best way to make sure patients get the most benefit with the least risk¹⁶.

Patient Reviews and Real-World Results

Enhertu is getting a lot of positive attention from patients and experts. It’s doing a great job treating HER2-positive cancers. Real-life stories show how some have done really well, while others have faced tough obstacles. This mix gives a full view of the treatment’s potential.

Success Stories

Patient feedback on Enhertu is superb. It often means more time for those with HER2-low metastatic breast cancer. They might get an extra five months without their cancer getting worse than with other treatments¹⁹. In comparison, those on Enhertu lived about six months longer than those on regular chemotherapy¹⁹. This underlines just how impactful the drug can be in these stories of success.

Challenges Faced

Even with its triumphs, using Enhertu can bring some challenges. People might find it hard to deal with side effects and keep up with their treatment. But, by taking hints from real-life studies, doctors are finding ways to improve these issues. For instance, patients treated with Enhertu experienced about 16 months without their cancer worsening. And their chances of surviving without their cancer progressing for 6 or 12 months were 77.0% and 61.9%, showing a real promise²⁰.

Expert Opinions

Experts in cancer therapy see Enhertu as a major step forward for HER2-related cancers. A study in the NEJM showed that it helps people live longer without their cancer spreading¹⁹. Important doctors also note that Enhertu has shown big benefits, helping over 70% of patients with HER2-positive brain cancer after six months²⁰. They praise Enhertu for filling a crucial gap in cancer care, adding to the positive feedback about the drug.

patient success stories

Results from the DESTINY-Breast04 study are also promising. The study found that, for certain patients, those on Enhertu lived longer than those with other treatments. The median survival was almost 24 months with Enhertu, compared to about 17.5 months with other treatments²¹. This shows the solid case for Enhertu in cancer care.

real-world oncology outcomesexpert views on cancer treatment

Outcome	Enhertu	Standard Chemotherapy
Progression-Free Survival	5 months longer	–
Overall Survival	6 months longer	–
PFS Rates at 6 Months	77.0%	–
PFS Rates at 12 Months	61.9%	–

Comparing Enhertu with Other Cancer Therapies

Enhertu is a top choice in the fight against cancer. It’s especially good with HER2-positive cancers, like metastatic breast cancer. In studies, it showed more shrinking or disappearing tumors and longer time without the cancer getting worse compared to Kadcyla²². For those with HER2-low metastatic breast cancer, Enhertu also led to longer lives than chemotherapy did²². This means Enhertu is better at fighting cancer than traditional drugs.

In the DESTINY-Breast06 Phase III trial, Enhertu outperformed chemotherapy for HER2-low patients. It decreased the risk of the disease getting worse or dying by 38% and more patients responded to it than to chemotherapy²³. These results show Enhertu is better than chemotherapy, bringing a stronger, longer-lasting effect against cancer.

Let’s not forget the cost of these therapies. Enhertu is more expensive than some, like Herceptin, yet it improves patient outcomes significantly. Its price reflects the value it brings²².

Setting money aside, Enhertu truly shines in the clinic. In the DESTINY-BREAST01 Phase 2 trials, more than half of patients responded well to Enhertu²⁴. It also increased the survival time for those with HER2-low breast cancer, showing its great potential against other drugs²⁴.

In the DESTINY-Breast07 trial, Enhertu did even better. When used alone, it led to a great response, and with pertuzumab, the response rate was even higher. This proves Enhertu’s excellence as an option in the HER2-targeted vs. chemotherapy debate²³.

Comparative Metrics	Enhertu	Chemotherapy
Tumor Shrinkage or Disappearance (HER2-positive)	82.7%	36.1%
Progression-Free Survival (HER2-positive)	18.5 months	5.6 months
Overall Median Survival (HER2-low)	23.4 months	16.8 months
Risk Reduction in Disease Progression (HER2-low)	38%	—
Confirmed ORR (HER2-low)	56.5%	32.2%

The Future of Enhertu in Oncology

The future of Enhertu in oncology looks really bright. It’s getting used for more types of cancer. Ongoing research points to better chances for patients to get well.

Ongoing Research

Research on Enhertu is trying to find its use in different cancers. In some types, like biliary tract and ovaries, it has worked well for over half of the patients. They felt the treatment’s impact for nearly 20 months²⁵. Trials now mix it with other cancer drugs. This could make it even more effective²⁶. Also, they are starting to test it on cancers at the early stage. This might make it useful for even more people²⁶.

Potential New Indications

Enhertu could soon be used more widely. The FDA has allowed its use across different cancers²⁵. This is a big move towards treatments tailored to each person’s needs²⁵. Sales figures show it’s being used more in clinics. Its future in cancer care looks very promising²⁶. As we move forward, we might see it being used even more widely.

Metric	Value	Source
Overall Response Rate	51%	25
Median Duration of Response	19.4 months	25
Sales Growth	$1.25 Billion to $2.5 Billion	26
Annual Revenue	$2.3 Billion in 2023	27
Patient Treatments	Over 81,000	27

In the end, Enhertu could really change how we treat cancer. It may give new hope to people all over the world. This future includes more types of cancer being treated with a personalized approach. It could mark a big shift in how we view and treat this disease.

Conclusion

Enhertu marks a big step forward in cancer care. It provides targeted options for HER2-positive cancers like breast, gastric, lung, and colorectal. In studies like the DESTINY-Breast03 Phase III, it outperformed usual treatments. This led to better progression-free survival and a hint at improved overall survival in HER2-positive breast cancer²⁸. Enhertu clearly helps patients a lot.

It’s shown through several trials that Enhertu is changing how we fight cancer. Compared to Kadcyla, it significantly increased survival without the disease, improved overall response rate, and had a big effect on reducing the risk of death²⁹. The DESTINY-Breast04 trial found that even HER2-low breast cancer patients benefited. This shows Enhertu might help across different HER2 types²⁹.

Studies are checking if Enhertu works in more cancers safely. Results look forward to helping patients even more. With ongoing approvals in many places, Enhertu could change how we treat cancer worldwide²⁸.

FAQ

What is Enhertu?

Enhertu is a special cancer drug that focuses on cancers with too much of a certain protein called HER2. It uses an antibody and a chemotherapy drug to treat these cancers without harming healthy cells.

Who developed Enhertu?

It was made by Daiichi Sankyo and AstraZeneca, companies big on fighting cancer with new medicines.

What cancers is Enhertu approved to treat?

It’s approved for HER2-positive breast and stomach cancers that have spread. It might also help with other cancers that have too much HER2.

How does Enhertu work?

Enhertu directly strikes at HER2 cancer cells. This helps to limit damage to healthy cells, unlike traditional chemotherapy.

What are the common side effects of Enhertu?

Nausea, anemia, and fatigue are usual. Talk to your doctor about these side effects to handle them well.

Are there serious side effects associated with Enhertu?

Yes, it can cause a serious lung problem. Monitoring closely can help avoid harms.

What should I know about the dosage and administration of Enhertu?

Dosages are set for each cancer type and patient. Following the prescription keeps the use of the drug safe and effective.

How is Enhertu different from traditional chemotherapy?

Enhertu targets only the cancer cells with too much HER2. This means it hurts fewer healthy cells than standard chemotherapy.

What are the DESTINY trials related to Enhertu?

These studies look into how safe and helpful Enhertu is for HER2 cancers. They helped get the drug approved and show its many uses.

What do patient reviews and real-world results indicate about Enhertu?

Feedback and data show Enhertu has changed the lives of those with HER2 cancers. Many say it works well, leading to better health.

What does the future hold for Enhertu in oncology?

Research and new uses could mean a bright future for Enhertu. It remains a key option in treating different types of cancer with precision.

How much does Enhertu cost?

Costs depend on the dose, how long the treatment is, and your healthcare provider. Check with your doctor and insurance for a clear cost idea.

Where can I find Enhertu prescribing information?

Your doctor or the companies’ websites can give you the detailed information about using Enhertu.

Source Links

1. https://daiichisankyo.us/press-releases/-/article/enhertu-granted-two-breakthrough-therapy-designations-in-u-s-for-patients-across-multiple-her2-expressing-cancers – Press Releases – Daiichi Sankyo US
2. https://www.ema.europa.eu/en/medicines/human/EPAR/enhertu – Enhertu | European Medicines Agency
3. https://www.komen.org/breast-cancer/facts-statistics/research-studies/topics/trastuzumab-deruxtecan-enhertu-treatment-for-metastatic-breast-cancer/ – Trastuzumab Deruxtecan (Enhertu) for Metastatic Breast Cancer Treatment – Susan G. Komen®
4. https://www.cancer.gov/news-events/cancer-currents-blog/2022/enhertu-her2-low-breast-cancer – Trastuzumab Deruxtecan for Metastatic HER2-Low Breast Cancer
5. https://www.cancer.gov/news-events/cancer-currents-blog/2021/enhertu-her2-metastatic-breast-cancer – Enhertu Effective in HER2-Positive Metastatic Breast Cancer
6. https://breastcancernow.org/about-breast-cancer/treatment/targeted-biological-therapy/trastuzumab-deruxtecan-enhertu/ – Trastuzumab deruxtecan (Enhertu)
7. https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-improved-pfs-in-her2-low-and-ultralow.html – Enhertu demonstrated statistically significant and clinically meaningful improvement in progression-free survival in HR-positive, HER2-low metastatic breast cancer following one or more lines of endocrine therapy in DESTINY-Breast06 Phase III trial
8. https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-enhertu-her2-positive-solid-tumors – Enhertu Approved for Any HER2-Positive Solid Cancer
9. https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-approved-in-the-us-as-first-tumour-agnostic-her2-directed-therapy-for-previously-treated-patients-with-metastatic-her2-positive-solid-tumours.html – Enhertu approved in the US as first tumour-agnostic HER2-directed therapy for previously treated patients with metastatic HER2-positive solid tumours
10. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshot-enhertu – Drug Trials Snapshot: ENHERTU
11. https://www.clinicaltrialsarena.com/news/enhertu-solid-tumour-trial/ – Enhertu offers survival benefits in Phase II solid tumour trial
12. https://www.daiichisankyo.com/media/press_release/detail/index_4088.html – DESTINY-Breast05 Head-to-Head Phase 3 Trial of ENHERTU® Versus T-DM1 Initiated in Patients with HER2 Positive Early Breast Cancer at High Risk After Neo-adjuvant Therapy – Press Releases – Media
13. https://www.medicalnewstoday.com/articles/drugs-enhertu-side-effects – Enhertu side effects: What to do about them
14. https://www.healthline.com/health/drugs/enhertu-side-effects – Enhertu Side Effects: What They Are and How to Manage Them
15. https://www.enhertu4u.com/patient/about-enhertu4u.html – About ENHERTU4U | ENHERTU4U (fam-trastuzumab deruxtecan-nxki) 20 mg/ml Injection for Intravenous Use
16. https://reference.medscape.com/drug/enhertu-trastuzumab-deruxtecan-4000032 – Enhertu (trastuzumab deruxtecan) dosing, indications, interactions, adverse effects, and more
17. https://www.drugs.com/dosage/enhertu.html – Enhertu Dosage Guide – Drugs.com
18. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761139s000lbl.pdf – label
19. https://www.pharmexec.com/view/survival-story-enhertu – Survival Story: Enhertu
20. https://www.onclive.com/view/trastuzumab-deruxtecan-demonstrates-real-world-intracranial-efficacy-in-metastatic-her2-breast-cancer – Trastuzumab Deruxtecan Demonstrates Real-World Intracranial Efficacy in Metastatic HER2+ Breast Cancer
21. https://www.ncbi.nlm.nih.gov/books/NBK599780/ – Clinical Review – Trastuzumab deruxtecan (Enhertu)
22. https://everyone.org/blog/enhertu-vs-herceptin – Enhertu vs Herceptin: What is the difference between these HER2-mutated cancer treatments?
23. https://www.astrazeneca.com/media-centre/press-releases/2024/Enhertu-demonstrated-median-progression-free-survival-thirteen-months.html – Enhertu demonstrated a median progression-free survival of 13.2 months in HR-positive, HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy
24. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9577648/ – Enhertu (Fam-trastuzumab-deruxtecan-nxki) – Revolutionizing treatment paradigm for HER2-Low breast cancer
25. https://www.moffitt.org/endeavor/archive/fda-approves-enhertu-for-her2-positive-solid-tumors/ – FDA Approves Enhertu for HER2-Positive Solid Tumors
26. https://www.pharmavoice.com/news/enhertu-daiichi-sankyo-astrazeneca-adc-ken-keller/715728/ – The Enhertu effect: Daiichi’s plan to build on the success of its crown jewel
27. https://www.daiichisankyo.com/files/investors/library/materials/2023/March 2024 ENHERTU Business Briefing_E_Final.pdf – PDF
28. https://www.astrazeneca.com/media-centre/press-releases/2021/enhertu-head-to-head-trial-meets-primary-endpoint.html – Enhertu significantly improved progression-free survival in DESTINY-Breast03 head-to-head trial vs. trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer
29. https://www.equinox-group.com/our-take-blog//enhertu-a-highly-innovative-therapy-for-second-line-metastatic-breast-cancer – Enhertu shows high clinical innovation in second-line metastatic breast cancer — Equinox Group