A Promising New Approach To Maintenance Therapy
- Data from the HER2CLIMB-05 study indicate that adding another drug, tucatinib (Tukysa), to the maintenance therapy phase for women with advanced HER2-positive (HER2+) breast cancer can significantly delay disease progression.
- It builds on strong earlier-line data that tucatinib (Tukysa) can help patients live longer and control brain metastases.
- It also opens up a new, chemo-free maintenance strategy that many oncologists expect will become a new standard for eligible patients once full details are presented and incorporated into guidelines.
- Data show adding tucatinib to trastuzumab + capecitabine (the current maintenance combination) improved median progression-free survival (PFS) to 24.9 months vs. 16.3 months in the placebo group.
Now, promising research from the HER2CLIMB-05 trial has indicated that adding a drug call tucatinib (Tukysa) can keep cancer at bay for longer.
Read MoreAn Added Benefit: What Did HER2CLIMB-05 Show?
HER2CLIMB-05 enrolled people with HER2+ metastatic breast cancer who had unresectable (cannot be removed by surgery) locally advanced or metastatic disease and had received standard first-line treatment with trastuzumab + pertuzumab + a taxane drug. Trial participants did not have disease progression on that initial therapy, and then moved into the “maintenance” phase without chemo.These patients were randomized to receive either:
- Tucatinib (Tukysa) + trastuzumab + pertuzumab
- Placebo + trastuzumab + pertuzumab
The primary endpoint was progression-free survival (PFS), or how long people lived without the cancer growing or causing death. Overall survival (OS) is a key secondary endpoint, but at this point, only PFS results have been released.
Topline results show that adding Tukysa to standard maintenance led to a significant and clinically meaningful improvement in PFS, which translates into more patients living with stable disease longer.
Importantly, these results come with a safety profile described as consistent with what we already know about tucatinib from prior studies.
Adding tucatinib to trastuzumab + capecitabine improved median PFS to 24.9 months vs. 16.3 months in the placebo group.
Even though OS data is immature, oncologists believe that moving tucatinib earlier, into first-line maintenance, may meaningfully change long-term outcomes.
The bottom line is that you may be able to stay on a chemo-free maintenance regimen longer, with a lower risk of your cancer breaking through, and with a drug whose side-effect profile is now very well studied.
Who Should Use Tukysa?
When your team is considering adding Tukysa (tucatinib) to first-line maintenance (with trastuzumab and pertuzumab), they look at how aggressive the cancer has been so far, how much disease is present, how well you responded to the first rounds of chemo, and whether there’s any concern about the cancer spreading to or already being in the brain.
Because tucatinib has strong data in protecting the brain and delaying progression, patients who are younger, have a long life expectancy, or have a higher risk of brain metastases are often the ones whom doctors lean more strongly toward adding it.
The other side of this panel is that Tucatinib is an oral drug taken long term, and it can cause diarrhea, fatigue, and liver-test changes. So your doctor will think about your baseline health, your gut and liver function, your daily routine, and how you feel about adding another pill into your life for months or years.
“These new therapeutics that are coming for each molecular subtype is really giving us a lot of options to treat our patients. The main challenge is going to be also to provide adequate access and produce these medications with costs that can be afforded globally,” Dr. Esteva explained.
Questions To Ask Your Doctor
- Am I a good candidate for adding Tukysa (tucatinib) to my treatment plan?
- What are the chances I will have significant diarrhea or liver problems on this regimen — and how can I manage them?
- What risks do I need to know about adding one more daily pill to my plan?
- Is there any reason (age, other illnesses, or prior treatments) that would make you lean against adding Tukysa for me?
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