Neoadjuvant T-DM1 Improves pCR in HER2+/HR+ Early Breast Cancer

Excerpt:

“Twelve weeks of neoadjuvant T-DM1 (ado-trastuzumab emtansine; Kadcyla) with or without endocrine therapy induced superior pathologic complete response (pCR) compared with trastuzumab (Herceptin) plus endocrine therapy in patients with HER2-positive/HR-positive early breast cancer, according to findings recently published online in theJournal of Clinical Oncology.

“In the prospective, neoadjuvant phase II ADAPT trial conducted by the West German Study Group, pCR was 41.0% for patients assigned to T-DM1 alone and 41.5% for those who received T-DM1 and endocrine therapy. In contrast, 15.1% of patients assigned to trastuzumab and endocrine therapy had a pCR (P<.001).”

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Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

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Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

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Breast Cancer Patients’ Distress at Withdrawal of Kadcyla

Excerpt:

“Terminal breast cancer patients have spoken of their distress after learning that a life-extending drug they had been told would be available to them looks set to be withdrawn.

“Advisory body NICE is reviewing drugs made available through the old cancer drugs fund, and has rejected Kadcyla for use on the NHS in England.

“It believes the price per patient set by manufacturer Roche is too expensive. Roche says discussions are continuing.”

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Study Findings Provide Latest Data on Neoadjuvant HER2+ Breast Cancer Treatment

Excerpt:

“Results from the KRISTINE and NSABP B-41 trials provided the latest data on the use of pertuzumab (Perjeta), trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), and lapatinib (Tykerb) for the neoadjuvant treatment of patients with HER2-positive breast cancer.

“In a lecture at the 2016 ASCO Annual Meeting, Stephen K. Chia, MD, an assistant professor in the division of Medical Oncology at the University of British Columbia, highlighted the key findings from these trials and their implications for the treatment of HER2+ breast cancer.”

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Expert Discusses Latest Data in Neoadjuvant HER2+ Breast Cancer

Excerpt:

“Results from the KRISTINE and NSABP B-41 trials presented at the 2016 ASCO Annual Meeting provided the latest data on the use of pertuzumab (Perjeta), trastuzumab (Herceptin), ado-trastuzumab emtansine (T-DM1; Kadcyla), and lapatinib (Tykerb) for the neoadjuvant treatment of patients with HER2-positive breast cancer.

“In a lecture at the conference, Stephen K. Chia, MD, an assistant professor in the division of Medical Oncology at the University of British Columbia, highlighted the key findings from these trials and their implications for the treatment of HER2+ breast cancer.”

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Novel Agents Emerging in Pipeline for HER2+ Breast Cancer

Excerpt:

“There have been significant advances for the treatment of HER2-positive breast cancer over the last decade, says Denise A. Yardley, MD.

“ ‘When we look at the HER2-positive patient, at this point, we have really come a long way with the initial approval of trastuzumab (Herceptin), followed by the addition of pertuzumab (Perjeta), based on the CLEOPATRA data,’ explains Yardley, senior investigator, Breast Cancer Research Program, principal investigator, Sarah Cannon Research Institute. ‘The EMILIA trial has now added T-DM1 (ado-trastuzumab emtansine; Kadcyla), a novel antibody-drug conjugate targeted against HER2.’

“While these FDA approvals have made a large impact for patients with HER2-positive breast cancer, there is still more work to be done. ‘We are really trying to extend the number of novel agents to add to the HER2-population arena,’ Yardley notes.”

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Neoadjuvant HER2+ Breast Cancer Options Need Refinement, Expert Says

Excerpt:

“While recent findings from the I-SPY 2 trial have shown potential with the combination of ado-trastuzumab emtansine (T-DM1; Kadcyla) and pertuzumab (Perjeta) for patients with HER2-positive breast cancer, the neoadjuvant space still has a lot of work ahead, according to Lisa A. Carey, MD.

“Results presented at the 2016 AACR Annual Meeting1 showed that, out of the 249 patients enrolled on the I-SPY 2 study, 54% of those who received T-DM1/pertuzumab experienced a pathological complete response (pCR) rate compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“This suggests that T-DM1 could increase overall survival (OS) in this patient population, but Carey adds more research with the regimen needs to be conducted.”

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Neoadjuvant T-DM1/Pertuzumab Combo Boosts pCR in HER2+ Breast Cancer

Excerpt:

“Neoadjuvant ado-trastuzumab emtansine (T-DM1; Kadcyla) in combination with pertuzumab (Perjeta) improved pathologic complete response (pCR) compared with standard of care in patients with advanced HER2-positive breast cancer, according to recently reported data from the adaptively randomized I-SPY 2 trial.

“Of the 249 patients with HER2-positive disease included in the I-SPY 2 trial, 54% of those who received T-DM1/pertuzumab experienced a pCR compared with 22% of those who received the combination of paclitaxel (Abraxane) plus trastuzumab (Herceptin).

“These findings suggest that T-DM1 may ultimately increase survival in these patients, says lead study author Angela M. DeMichele, MD, professor of Medicine and Epidemiology at the University of Pennsylvania.”

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