On May 16, 2018 TESARO, Inc. (NASDAQ:TSRO), an oncology-focused biopharmaceutical company, reported the presentation of five ZEJULA (niraparib) abstracts, including two oral presentations, at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held June 1 to June 5, 2018, in Chicago, Illinois (Press release, TESARO, MAY 16, 2018, View Source [SID1234526719]). In addition, TESARO will webcast an investor and analyst briefing on Monday, June 4 at 6:15PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting.

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"TESARO has a targeted clinical development program to assess ZEJULA monotherapy activity in the front-line ovarian cancer setting and in combination with bevacizumab or anti-PD-1 in ovarian, breast and lung cancer," said Mary Lynne Hedley, Ph.D., President and COO of TESARO. "At this year’s ASCO (Free ASCO Whitepaper) Annual Meeting, we look forward to oral presentations of results from the TOPACIO trial of niraparib plus anti-PD-1 in patients with triple-negative breast cancer or recurrent ovarian cancer, and a poster presentation of data from the QUADRA trial, which evaluated niraparib as a treatment for patients with advanced ovarian cancer."

Please plan to visit TESARO at Booth #10123 to learn more about ZEJULA, TSR-042 (anti-PD-1 antibody), TSR-022 (anti-TIM-3 antibody), and TSR-033 (anti-LAG-3 antibody).

Presentation Details:

Sunday, June 3, 2018, 9:45AM to 11:15AM
TOPACIO/Keynote-162 (NCT02657889): A phase 1/2 study of niraparib + pembrolizumab in patients (pts) with advanced triple-negative breast cancer or recurrent ovarian cancer (ROC): results from ROC cohort.
Oral Presentation; Abstract #106, 10:21AM, Location: Hall D1

Monday, June 4, 2018, 1:15PM to 4:45PM
Cost-effectiveness of niraparib versus routine surveillance, olaparib, and rucaparib for the maintenance treatment of adult patients with ovarian cancer in the United States.
Poster Presentation; Abstract #5559, Poster Board #286, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
OVARIO: The phase 2, single-arm, open-label study of maintenance therapy with niraparib + bevacizumab in patients with advanced ovarian cancer following response on frontline platinum- based chemotherapy.
Poster Presentation; Abstract #TPS5606, Poster Board #330a, Location: Hall A

Monday, June 4, 2018, 1:15PM to 4:45PM
QUADRA: A phase 2, open-label, single-arm study to evaluate niraparib in patients (pts) with relapsed ovarian cancer (ROC) who have received >3 prior chemotherapy regimens.
Poster Presentation: Abstract #5514, Poster Board #241 Location: Hall A
Poster Discussion: Monday, June 4, 4:45PM – 6:00PM; Location: S100bc

Monday, June 4, 2018, 3:00PM to 4:30PM
TOPACIO/Keynote-162: Niraparib + pembrolizumab in patients (pts) with metastatic triple- negative breast cancer (TNBC), a phase 2 trial.
Oral Presentation; Abstract #1011, 3:36PM, Location: Hall D2

Investor Briefing and Webcast
TESARO will host an investor and analyst briefing in Chicago on Monday, June 4th at 6:15 PM local time in conjunction with the ASCO (Free ASCO Whitepaper) Annual Meeting. A reception will begin at 6:00 PM CT, preceding the presentation. During this briefing, TESARO management will provide a business overview and pipeline update and will answer questions from investors and analysts. This event will be webcast live and archived for 30 days, and may be accessed from the TESARO Investor Events and Presentations webpage at www.tesarobio.com.

The TOPACIO trial is being conducted in collaboration with Merck Sharp & Dohme B.V., a subsidiary of Merck & Co., Inc., which is providing support for the trial.

On May 16, 2018 Delcath Systems, Inc. (OTCQB:DCTHD), an interventional oncology company focused on the treatment of primary and metastatic liver cancers, reported that the German Guidelines Program in Oncology (GGPO) has included treatment with Delcath’s CHEMOSAT in the German national treatment guidelines for liver metastases from melanoma (Press release, Delcath Systems, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349370 [SID1234526685]). This inclusion of treatment with CHEMOSAT is in the S3 Guidelines, which represents the highest level within the classification of the guidelines indicating that it is based on evidence and consensus within the German clinical community.

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The GGPO’s update was based on its evaluation of published data on treatment with CHEMOSAT as a loco-regional treatment for melanoma liver metastases. Following this evaluation, and after soliciting additional feedback from the oncology community in Germany, treatment with CHEMOSAT was classified with Evidence Level 1B, indicating the second highest level of evidence. Treatment with CHEMOSAT is the sole therapy classified with this top designation. Other loco-regional therapies previously included in the guidelines have been designated with Evidence Level 4, indicating an absence of clinical trial supporting evidence.

"Inclusion in the GGPO treatment guidelines reflects the steady accumulation of both clinical data and experience built with our therapy in Germany over the last several years," said Jennifer K. Simpson, PhD, MSN, CRNP, President and Chief Executive Officer of Delcath Systems. "Importantly, the guidelines established that treatment with CHEMOSAT is the best supported option for patients with melanoma liver metastases based on current evidence. Through our Clinical Development Program and our commercialization efforts in Germany and other European markets, we are working toward establishing treatment with CHEMOSAT as a first line treatment option for appropriately selected patients.

On May 16, 2018 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer reported positive data from the FORWARD II trial evaluating mirvetuximab soravtansine in multiple combination cohorts in patients with folate receptor alpha (FRα)-positive ovarian cancer (Press release, ImmunoGen, MAY 16, 2018, View Source [SID1234526704]). Results from the cohort assessing mirvetuximab in combination with Avastin (bevacizumab) in patients with platinum-resistant disease will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 1-5 in Chicago, IL. In addition, ImmunoGen reported updated data from the dose-escalation cohort evaluating mirvetuximab in combination with carboplatin in patients with recurrent platinum-sensitive ovarian cancer.

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"Building upon the encouraging data generated with mirvetuximab monotherapy, we have looked to expand our addressable patient population through combination regimens with both currently approved and experimental agents in ovarian cancer. In dose escalation, we have demonstrated that full dose mirvetuximab can be combined safely with full doses of Avastin, carboplatin, or Keytruda, with encouraging preliminary clinical activity," said Anna Berkenblit, MD, Vice President and Chief Medical Officer of ImmunoGen. "The promising new data reported in the FORWARD II Avastin and carboplatin arms support the potential of mirvetuximab combinations in earlier lines of therapy. Together, these results have informed the triplet combination study with mirvetuximab plus carboplatin and Avastin, which we initiated last quarter."

Berkenblit continued, "In addition, we plan to present initial data from the Keytruda expansion cohort later this year, building upon the dose escalation data recently presented at SGO. The totality of these data from FORWARD II will guide the next stages of development of mirvetuximab and support a path to registration for combination regimens."

DATA FROM FORWARD II EXPANSION COHORT WITH AVASTIN
Mirvetuximab soravtansine in combination with Avastin in patients with platinum-resistant ovarian cancer has demonstrated anti-tumor activity with durable responses and a favorable tolerability profile, particularly among the subset of patients who have received up to three prior lines of therapy and have medium or high levels of FRα expression. This is the population being studied in the FORWARD I Phase 3 registration trial.

Key findings in 59 patients with platinum-resistant ovarian cancer include:

In the subset of 23 patients evaluable for response with medium or high FRα expression levels who have received up to three prior lines of therapy, the confirmed overall response rate (ORR) was 48 percent (95% CI 27,69), with a median progression-free survival (PFS) of 9.9 months (95% CI 4.6,14.5) and a median duration of response (DOR) of 10.6 months (95% CI 3.3,12.0).
For the 54 patients evaluable for response, the confirmed ORR was 43 percent (95% CI 29,57), with a median PFS of 7.8 months (95% CI 5.6,10.2); patients in this cohort had received a median of 3 prior lines of systemic therapy, with 58 percent of patients having received prior bevacizumab.
The combination continues to display a safety profile in-line with the known profiles of each agent, with no new safety signals identified.
"The mirvetuximab and Avastin combination has demonstrated very encouraging initial clinical activity in ovarian cancer patients and a consistently favorable safety profile," stated David O’Malley, M.D., Professor, Director of Gynecology Clinical Trial and Phase 1 Program, James Cancer Center and The Ohio State University Wexner Medical Center, and FORWARD II Investigator. "There is a significant need for new therapeutic options to improve outcomes and tolerability for this difficult-to-treat patient population, and I believe these results support further clinical evaluation of this combination regimen."

ASCO PRESENTATION DETAILS
Title: Mirvetuximab soravtansine, a folate receptor alpha (FRα)-targeting antibody-drug conjugate (ADC), in combination with bevacizumab in patients (pts) with platinum-resistant ovarian cancer: maturing safety and activity profile from the FORWARD II Phase 1b study
Presenter: David M. O’Malley, MD, The Ohio State University College of Medicine
Day/Time: Monday, June 4, 1:15-4:45 pm CDT
Location: Hall A
Abstract: 5549

Additional information, can be found at www.asco.org.

UPDATED DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH CARBOPLATIN
Initial findings from a dose escalation cohort of mirvetuximab in combination with carboplatin were presented at ASCO (Free ASCO Whitepaper) 2017. The data have matured and updated findings in heavily pre-treated patients with platinum-sensitive ovarian cancer include:

In the subset of 10 patients with medium or high FRα expression levels, the confirmed ORR was 80 percent (95% CI 44,98), with a median PFS of 15 months (95% CI 9.9,-), and with median DOR not reached.
For all 17 evaluable patients, the confirmed ORR was 71 percent (95% CI 44,90), with a median PFS of 15 months (95% CI 9.9, -), and with median DOR not reached; 50 percent of patients in this cohort had received 3 or more prior lines of systemic therapy.
The combination continues to display a favorable safety profile in-line with the known profiles of each agent, with no new safety signals identified.
Based on the findings from the carboplatin and Avastin cohorts, ImmunoGen recently initiated an additional cohort assessing a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with recurrent platinum-sensitive ovarian cancer as part of the FORWARD II trial.

DATA FROM FORWARD II DOSE-ESCALATION COHORT WITH KEYTRUDA
Additionally, ImmunoGen recently announced encouraging activity and favorable tolerability data from the FORWARD II cohort assessing mirvetuximab in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in patients with platinum-resistant ovarian cancer at the Society of Gynecologic Oncology Annual Meeting. Based on these data, ImmunoGen is completing enrollment in an expansion cohort that includes an additional 35 patients with medium or high FRα expression levels. ImmunoGen plans to report initial findings from this cohort in the second half of this year.

CONFERENCE CALL INFORMATION
ImmunoGen will host a conference call on Thursday, May 17 at 8:00am ET to discuss new data from the FORWARD II trial. To access the live call by phone, dial 323-794-2423; the conference ID is 5718620. The call may also be accessed through the "Investors" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay of the call will be available at the same location through June 7, 2018.

ABOUT FORWARD II
FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin (bevacizumab), carboplatin or Keytruda (pembrolizumab) in patients with FRα-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is the first folate receptor alpha (FRα)-targeting ADC. It uses a humanized FRα-binding antibody to target the ADC specifically to FRα-expressing cancer cells and a potent anti-tumor agent, DM4, to kill the targeted cancer cells.

On May 16, 2018 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that five abstracts have been selected for poster presentations at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 1-5, 2018 in Chicago (Press release, Verastem, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349503 [SID1234526720]).

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The Company will present data on its lead product candidate, duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, as well as defactinib, its oral small molecule inhibitor of Focal Adhesion Kinase (FAK). The poster presentations will highlight the latest findings from the Company’s ongoing clinical trials for duvelisib, the Phase 3 DUO study crossover extension in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), in addition to a Phase 1 study of defactinib in combination with pembrolizumab and gemcitabine in patients with relapsed/refractory pancreatic cancer.

A poster will also be presented on PRIMO, a Phase II study that Verastem Oncology has initiated to evaluate duvelisib monotherapy in peripheral T-cell lymphoma (PTCL), one of the most aggressive forms of non-Hodgkin lymphoma (NHL). The U.S. Food and Drug Administration (FDA) has granted fast track designation to the investigation of duvelisib for the potential treatment of patients with peripheral T-cell lymphoma (PTCL) who have received at least one prior therapy. This study was initiated based on promising activity observed with duvelisib monotherapy in T-cell lymphomas in the Phase I study. In addition, posters on biomarker measurements in the DUOTM and DYNAMOTM studies, as well as in a treatment naive follicular lymphoma study, will be presented.

"In the crossover extension trial of the Phase 3 DUO study, patients treated with duvelisib following confirmed disease progression on prior ofatumumab therapy exhibited a 73% overall response rate (ORR), compared to a 28% ORR with ofatumumab in the DUO study. These results were consistent with the ORR of patients originally initiated on duvelisib. This response rate was accompanied by a longer median progression-free survival (mPFS), with duvelisib-treated patients achieving 15-month mPFS, compared to 9 months when they were treated with ofatumumab," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology.

Dr. Le added, "For our lead FAK inhibitor defactinib, Dr. Andrea Wang-Gillam will describe initial results from the ongoing Phase 1 study evaluating defactinib in combination with pembrolizumab and gemcitabine in patients with advanced pancreatic cancer. In addition to defining a recommended Phase 2 dose, the combination regimen has been well tolerated with promising signs of clinical activity, including one confirmed partial response in a pancreatic cancer patient and stable disease in additional pancreatic patients."

"Data presented at this year’s ASCO (Free ASCO Whitepaper) meeting by Verastem Oncology and collaborative researchers also directly demonstrate inhibition of both PI3K-delta and PI3K-gamma in patients treated with duvelisib," said Jonathan Pachter, PhD, Chief Scientific Officer of Verastem Oncology. "Accordingly, biomarker changes observed in duvelisib-treated patients indicate targeting of malignant B-cells directly along with targeting of the supportive tumor microenvironment."

Details for the ASCO (Free ASCO Whitepaper) 2018 presentations are as follows:

Duvelisib

Title: The efficacy of duvelisib monotherapy following disease progression on ofatumumab monotherapy in patients with relapsed/refractory CLL or SLL in the DUO crossover extension study
Lead author: Dr. Bryone Kuss, Flinders Medical Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 170
Abstract #: 7533
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The effect of duvelisib, a dual inhibitor of PI3K-δ,γ, on components of the tumor microenvironment in previously untreated follicular lymphoma
Lead author: Dr. Carla Casulo, University of Rochester, Wilmot Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 216
Abstract #: 7579
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: The PRIMO study: A phase 2 study of duvelisib efficacy and safety in patients with relapsed or refractory peripheral t-cell lymphoma (PTCL)
Lead author: Dr. Steven Horwitz, Memorial Sloan Kettering Cancer Center
Session: Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Poster #: 222b
Abstract #: TPS7590
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

Title: Duvelisib inhibition of chemokines in patients with CLL (DUO study) and iNHL (DYNAMO study)
Lead author: Dr. David Weaver, Verastem Oncology
Session: Tumor Biology
Poster #: 161
Abstract #: 12048
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 1:15 – 4:45 p.m. CT

Defactinib

Title: Phase I study of defactinib combined with pembrolizumab and gemcitabine in patients with advanced cancer
Lead author: Dr. Andrea Wang-Gillam, Washington University School of Medicine in St. Louis
Session: Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics
Poster #: 387
Abstract #: 2561
Location: McCormick Place Hall A
Date and Time: Monday, June 4, 8:00 – 11:30 a.m. CT

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

About Defactinib

Defactinib is an investigational inhibitor of focal adhesion kinase (FAK), a non-receptor tyrosine kinase that mediates oncogenic signaling in response to cellular adhesion and growth factors.7 Based on the multi-faceted roles of FAK, defactinib is used to treat cancer through modulation of the tumor microenvironment and enhancement of anti-tumor immunity.8,9 Defactinib is currently being evaluated in three separate clinical collaborations in combination with immunotherapeutic agents for the treatment of several different cancer types including pancreatic cancer, ovarian cancer, non-small cell lung cancer (NSCLC), and mesothelioma. These studies are combination clinical trials with pembrolizumab and avelumab from Merck & Co. and Pfizer/Merck KGaA, respectively.10,11,12 Information about these and additional clinical trials evaluating the safety and efficacy of defactinib can be found on www.clinicaltrials.gov

On May 16, 2018 Endocyte, Inc. (Nasdaq:ECYT), a biopharmaceutical company developing targeted therapeutics for personalized cancer treatment, reported that a poster with data from the Peter MacCallum Cancer Centre will be presented on Endocyte’s lead investigational therapy at the 2018 ASCO (Free ASCO Whitepaper) Annual Meeting on Saturday, June 2, 2018 (Press release, Endocyte, MAY 16, 2018, View Source [SID1234526737]). Updated data from the phase 2 study of 177Lu-PSMA-617 as a potential treatment for metastatic castration-resistant prostate cancer (mCRPC), including data from an additional 20 patient expansion cohort, will be highlighted by the poster.

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"We are very pleased that we continue to see high rates of PSA response, even in heavily pre-treated patients," said Mike Sherman, president and CEO of Endocyte. "In the 50 patients receiving 177Lu-PSMA-617, 62% had a greater than 50% reduction in their PSA levels. Further, 44% of patients had a PSA reduction of 80% or greater. We look forward to sharing more information on this phase 2 trial at ASCO (Free ASCO Whitepaper). We recently reported median overall survival of 13.5 months for the first cohort of 30 patients enrolled. The median overall survival in the total 50 patients is not yet meaningful as follow-up in the second cohort of 20 patients is between 6 and 9 months at the time of cutoff. Updated survival metrics will be presented at a future medical conference as that data matures."

ASCO Presentation Details:

Abstract #: 5040 (Poster Board: #267)
Title: Lutetium-177 PSMA617 theranostics in metastatic castrate-resistant prostate cancer (mCRPC): Interim results of a phase II trial.
When: Saturday, June 2, 2018 at 1:15 p.m. – 4:45 p.m. CDT
Session Title: Genitourinary (Prostate) Cancer
Location: Hall A

Webcast Investor Event and 177Lu-PSMA-617 Panel Discussion:

The Company will host a reception and webcast panel discussing 177Lu-PSMA-617 for investors and analysts on Monday, June 4, 2018 from 6:00 p.m.- 8:00 p.m. CDT. Panelists scheduled to participate at the event include:

Alison Armour, M.B., Ch.B., B.Sc, M.Sc, M.D., F.R.C.P., F.R.C.R., Chief Medical Officer, Endocyte
Johann S de Bono, M.D., M.Sc, Ph.D, F.R.C.P., Regius Professor of Cancer Research; Professor, The Royal Marsden NHS Foundation Trust (UK)
Oliver Sartor, M.D., C.E. & Bernadine Laborde Professor for Cancer Research; Medical Director, Tulane Cancer Center
A live audio webcast of the event can be accessed by visiting "Events & Presentations" under the Investors & News section of Endocyte’s website at www.endocyte.com. The webcast will be archived shortly after the live event, and a replay will be available on the Company’s website for at least 90 days following the event.

Website Information:

Endocyte routinely posts important information intended for investors on its website, www.endocyte.com, in the "Investors & News" section. Endocyte uses this website as a means of disclosing material information in legal compliance with its disclosure obligations under Regulation FD. Accordingly, investors should monitor the "Investors & News" section of Endocyte’s website, in addition to following the company’s press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, the Endocyte website is not incorporated by reference into, and is not a part of, this document.