About the two study drugs in Triple Negative Breast Cancer
Both study drugs are FDA approved.
Halaven is approved for advanced breast cancer and Keytruda for different cancer indications.
As single therapies, both Halaven and Keytruda have shown promising antitumor activity in metastatic Triple Negative Breast Cancer, mTNBC.
Emerging data suggest that the addition of immunotherapy to traditional chemotherapy holds promise for mTNBC.
About ENHANCE-1 study
This open-label, single-arm, phase 1b/2 study evaluated the safety and efficacy of Halaven plus Keytruda in mTNBC.
Patients with mTNBC and 0-2 prior therapies for metastatic disease were enrolled and analyzed by prior number of treatments: Group I – 0 prior therapies and Group II – 1–2 prior therapies.
167 patients were enrolled and treated. Group I consisted of 66 patients and Group II had 101 patients.
All patients received Halaven plus Keytruda.
Assessments also included efficacy outcomes by PD-L1 expression status. PD-L1 was tested using the PDL1 IHC 22C3 pharmDx.
Results
Side Effects
The most common side events were fatigue (66%), nausea (57%), peripheral sensory neuropathy (41%), alopecia (40%), and constipation (37%). No deaths were considered treatment related.
Efficacy
23.4% of patients responded to the combination, which are closely 1 in 4 patients.
Efficacy outcomes by PD-L1 status
74 patients had PD-L1+ and 75 had PDL1-.
Group I, 29 patients had PD-L1+
- 34.5% of patients responded and their cancer had stopped from growing or shrunken
- Median survival reached 24 months
- Median time until disease progression from the start of the Halaven and Keytruda was 6.1 months
Group I, 31 patients had PD-L1-
- 16.1% of patients responded and their cancer had stopped from growing or shrunken
- Median Survival reached 15.2 months
- Median time until disease progression from the start of the Halaven and Keytruda was 3.5 months
Group II, 45 patients had PD-L1+
- 24.4% of patients responded and their cancer had stopped from growing or shrunken
- Median Survival reached 14 months
- Median time until disease progression from the start of the Halaven and Keytruda was 4.1 months
Group II, 45 patients had PD-L1-
- 18.2% of patients responded and their cancer had stopped from growing or shrunken
- Median Survival reached 15.5 months
- Median time until disease progression from the start of the Halaven and Keytruda was 3.9 months
Conclusions
- Halaven plus Keytruda has activity in patients with metastatic Triple Negative Breast Cancer, mTNBC that appears greater than known reports of either agent alone.
- There was a trend toward more robust activity for the combination among patients with PD-L1+ tumors compared to PD-L1- tumors in Group I patients, for whom this was the first therapy for their metastatic disease.
The best treatment for a cancer patient is to get the most advanced cancer drugs in advanced stages of development. There, the hope and the chance to extend life go far beyond the standard protocols.
Contact us to find out what is the best treatment for YOU
TRIAL•IN Pharma
Because we, do not give up on life!
Contact us 24/7 –
Call center +44.2082.426.039
For further reading about Breast Cancer>>
