- Achieved 35% objective response rate, including 10% complete response rate, and 80% disease control rate among twenty evaluable patients with ovarian cancer
- Data continue to support a NaPi2b biomarker-based patient selection strategy
- Generally well-tolerated with no new safety signals
- Data to be presented on a conference call today at 8 a.m. ET and at the American Society of Clinical Oncology 2020 Virtual Scientific Program on Friday, May 29, 2020
Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today reported interim safety, tolerability and efficacy data from the ongoing expansion portion of the Phase 1 study evaluating XMT-1536, its first-in-class ADC candidate targeting NaPi2b, in patients with ovarian cancer and non-small cell lung (NSCLC) adenocarcinoma.
The Company will host a conference call and webcast today, Wednesday, May 27, 2020, at 8:00 a.m. ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data. These data will also be presented in a poster session at the American Society of Clinical Oncology 2020 Virtual Scientific Program on Friday, May 29, 2020 starting at 8:00 a.m. ET.
“These data demonstrate not only that XMT-1536, our first-in-class Dolaflexin ADC targeting NaPi2b, can deliver confirmed complete responses, partial responses and durable stable disease in platinum-resistant ovarian cancer, but also that these responses can deepen over time in a patient population with poor prognosis and limited treatment options,” said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. “XMT-1536 continues to demonstrate that it is generally well tolerated, without the dose-limiting toxicities of other ADC platforms such as severe neutropenia, neuropathy and ocular toxicity. These are encouraging signals as we look forward to reporting more mature data in the second half of the year and continuing to advance XMT-1536 for both platinum-resistant ovarian cancer and NSCLC adenocarcinoma patients.”
The expansion portion of the Phase 1 study is enrolling patients with platinum-resistant ovarian cancer, fallopian tube or primary peritoneal cancer who have received up to three lines of prior therapy and in some cases four lines of prior therapy regardless of platinum status as well as patients with NSCLC adenocarcinoma who had received prior treatment with platinum-based therapy and immunotherapy or targeted agents. With a data cutoff of May 1, 2020 these data include 34 patients total, 27 with ovarian cancer and seven with NSCLC adenocarcinoma. Patients with ovarian cancer had a median of three prior lines of treatment (range 1-5), and patients with NSCLC adenocarcinoma had a median of two lines of therapy (range 1-3). Fifteen of the patients were dosed at 36 mg/m2, and 19 patients were dosed at 43 mg/m2 every four weeks.
|Response – Ovarian Cancer N=20*||All||Higher NaPi2b o||Lower NaPi2b oo||NaPi2b Not Yet Determined|
|CR||2 (10%)||2 (14%)||0 (0%)||0 (0%)|
|PR||5 (25%)||2 (14%)||1 (25%)||2 (100%)|
|uPR**||1 (5%)||1 (7%)||0 (0%)||0 (0%)|
|SD||8 (40%)||7 (50%)||1 (25%)||0 (0%)|
|PD||4 (20%)||2 (14%)||2 (50%)||0 (0%)|
*7 patients not evaluable: 1 withdrew consent (Lower NaPi2b Expression); 1 with unrelated SAE leading to discontinuation and death (Lower NaPi2b Expression); 5 have not yet received a scan
**uPR=1 patient with unconfirmed PR; confirmatory scan pending at the time of data cut
° Higher NaPi2b Expression: defined in dose escalation as at / above lowest H-score at which response observed (≥110)
°° Lower NaPi2b Expression: defined in dose escalation as below the lowest H-score at which response observed (<110)
|•||More data are needed to assess antitumor activity of XMT-1536 in NSCLC adenocarcinoma patients.|
|◦||At the time of data cutoff, four out of seven NSCLC adenocarcinoma patients were evaluable for response, and 2/4 (50%) patients had achieved SD as best response.|
Conference Call Details
Mersana Therapeutics will host a conference call and webcast today at 8:00 a.m. ET during which investigator Debra L. Richardson, MD, Associate Professor of Gynecologic Oncology at the Stephenson Cancer Center at the University of Oklahoma Health Sciences Center and the Sarah Cannon Research Institute and members of the Mersana executive team will present and discuss these data. To access the call, please dial 877-303-9226 (domestic) or 409-981-0870 (international) and provide the Conference ID 7785868. A live webcast of the presentation will be available on the Investors & Media section of the Mersana website at www.mersana.com.
About Mersana Therapeutics
Mersana Therapeutics is a clinical-stage biopharmaceutical company using its differentiated and proprietary ADC platforms to rapidly develop novel ADCs with optimal efficacy, safety and tolerability to meaningfully improve the lives of people fighting cancer. Mersana’s lead product candidate, XMT-1536, is in the expansion portion of a Phase 1 proof-of-concept clinical study in patients with ovarian cancer and NSCLC adenocarcinoma. XMT-1592, Mersana’s second ADC product candidate targeting NaPi2b-expressing tumors, was created using Mersana’s customizable and homogeneous Dolasynthen platform and is in the dose escalation portion of a Phase 1 proof-of-concept clinical study. The Company’s early stage programs include a B7-H4 targeting ADC, as well as a STING-agonist ADC developed using the Company’s Immunosynthen platform. In addition, multiple partners are using Mersana’s Dolaflexin platform to advance their ADC pipelines.
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