Nav: Home

PharmaMar announces positive results from its Phase 2 study with PM1183 in BRCA 1/2 MBC

October 11, 2016

PharmaMar (MSE:PHM) has announced the positive results of its Phase II study of lurbinectedin (PM1183) in patients with BRCA 1 / 2 -associated metastatic breast cancer, who had previously received a maximum of 3 prior chemotherapy regimens.

Approximately, 5-10% of breast cancers are associated with the BRCA 1 or 2 hereditary mutations. For the moment the treatment of these patients is similar to any other type of breast cancers, that is mainly conditioned by their hormone receptor and HER2 status. However, recent studies around the mutation demonstrate that these types of tumors behave differently in breast cancer, therefore, the patients harboring these mutations could benefit from a more specific treatment.

Doctor Judith Balmaña, oncology expert from the Vall D´Hebron Institute of Oncology, and principal investigator of the trial, presented the data at an oral session at the European Society of Medical Oncology (ESMO) Congress, being held in Copenhagen, Denmark, that started on the 7th and running to the 11th of October.

The primary endpoint of the trial is to analyze the antitumoral activity of lurbinectedin in this cohort of patients in terms of overall response rate (ORR), according to the Response Evaluation Criteria in Solid Tumors (RECIST V1.1). 54 patients were treated in total and a significant reduction in tumor size was observed in 22 of them (ORR 41%). The primary endpoint of at least 17 responses was comfortably achieved. It is important to emphasize that the ORR of the patients with BRCA 2 gene mutation subgroup was 61%, while in those patients with BRCA 1 gene mutation, the figure was 26%.

Apart from this parameter, others, such us median duration of response (6.7 months), progression free survival (4.1 months), one year overall survival (15.9 months), and clinical benefit (reduction in tumor lesions, or at least 3 months stability) in 61% of patients were observed.

Throughout the clinical trial, the 7 mg initial dose of lurbinectedin was adjusted to 3.5 mg/m2, both being administered intravenously every three weeks with the objective of improving the safety profile of the drug.

The investigator´s team, led by Dr Balmaña, arrived to the conclusion that lurbinectedin (PM1183) is an active compound in BRCA associated metastatic breast cancer, even independently of the prior treatment with platinum. With the dose adjustment to 3.5 mg/m2, the tolerance to the drug was significantly improved, while the compound´s efficacy was maintained.

PharmaMar will continue with the clinical development of this molecule in patients with this type of metastatic cancer, given the clinical results obtained in this Phase II study.
About PM1183 (lurbinectedin)

PM1183 is a compound under clinical investigation. It is an inhibitor of RNA polymerase II. This enzyme is essential for the transcription process that is over-activated in tumors with transcription addiction. The antitumor efficacy of lurbinectedin is being investigated in various types of solid tumors, including a Phase III study for platinum-resistant ovarian cancer, a Phase II study for BRCA 1 and BRCA 2-associated metastatic breast cancer and a Phase III study for small cell lung cancer.

About BRCA 1 / 2 -associated metastatic breast cancer

Breast cancer is the most frequent form of cancer in women in the Western world . Between 5-10% of breast cancers are associated with the hereditary mutation of the BRCA (BRCA 1 or BRCA 2) genei. It is estimated that bearers of the BRCA 1 / 2 gene mutation run the risk of developing breast cancer during their life of 60-70% and 45-55%, respectively . Almost 12% of the female population will suffer breast cancer at some stage of their life .


Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer satistics, 2012. CA: a cancer journal for clinicians. 2015 Mar;65(2):87-108

Balmaña J, Diez O, Rubio IT, et al. BRCA in breast cancer: ESMO Clinical Pratice Guidelines. Ann Oncol 2011; 22 Suppl 6:vi31-4

Howlader N, Noone AM, Krapcho M, et al. (eds). SEER Cancer Statistics Review, 1975-2011, National Cancer Institute. Bethesda, MD,, based on November 2013 SEER data submission, posted to the SEER web site, April 2014


Related Breast Cancer Articles:

Does MRI plus mammography improve detection of new breast cancer after breast conservation therapy?
A new article published by JAMA Oncology compares outcomes for combined mammography and MRI or ultrasonography screenings for new breast cancers in women who have previously undergone breast conservation surgery and radiotherapy for breast cancer initially diagnosed at 50 or younger.
Blood test offers improved breast cancer detection tool to reduce use of breast biopsy
A Clinical Breast Cancer study demonstrates Videssa Breast can inform better next steps after abnormal mammogram results and potentially reduce biopsies up to 67 percent.
Surgery to remove unaffected breast in early breast cancer increases
The proportion of women in the United States undergoing surgery for early-stage breast cancer who have preventive mastectomy to remove the unaffected breast increased significantly in recent years, particularly among younger women, and varied substantially across states.
Breast cancer patients with dense breast tissue more likely to develop contralateral disease
Breast cancer patients with dense breast tissue have almost a two-fold increased risk of developing disease in the contralateral breast, according to new research from The University of Texas MD Anderson Cancer.
Some early breast cancer patients benefit more from breast conservation than from mastectomy
Breast conserving therapy (BCT) is better than mastectomy for patients with some types of early breast cancer, according to results from the largest study to date, presented at ECC2017.
One-third of breast cancer patients not getting appropriate breast imaging follow-up exam
An annual mammogram is recommended after treatment for breast cancer, but nearly one-third of women diagnosed with breast cancer aren't receiving this follow-up exam, according to new findings presented at the 2016 Annual Clinical Congress of the American College of Surgeons.
Low breast density worsens prognosis in breast cancer
Even though dense breast tissue is a risk factor for breast cancer, very low mammographic breast density is associated with a worse prognosis in breast cancer patients.
Is breast conserving therapy or mastectomy better for early breast cancer?
Young women with early breast cancer face a difficult choice about whether to opt for a mastectomy or breast conserving therapy (BCT).
Breast density and outcomes of supplemental breast cancer screening
In a study appearing in the April 26 issue of JAMA, Elizabeth A.
Full dose radiotherapy to whole breast may not be needed in early breast cancer
Five years after breast-conserving surgery, radiotherapy focused around the tumor bed is as good at preventing recurrence as irradiating the whole breast, with fewer side effects, researchers from the UK have found in the large IMPORT LOW trial.

Related Breast Cancer Reading:

Best Science Podcasts 2019

We have hand picked the best science podcasts for 2019. Sit back and enjoy new science podcasts updated daily from your favorite science news services and scientists.
Now Playing: TED Radio Hour

Jumpstarting Creativity
Our greatest breakthroughs and triumphs have one thing in common: creativity. But how do you ignite it? And how do you rekindle it? This hour, TED speakers explore ideas on jumpstarting creativity. Guests include economist Tim Harford, producer Helen Marriage, artificial intelligence researcher Steve Engels, and behavioral scientist Marily Oppezzo.
Now Playing: Science for the People

#524 The Human Network
What does a network of humans look like and how does it work? How does information spread? How do decisions and opinions spread? What gets distorted as it moves through the network and why? This week we dig into the ins and outs of human networks with Matthew Jackson, Professor of Economics at Stanford University and author of the book "The Human Network: How Your Social Position Determines Your Power, Beliefs, and Behaviours".