On May 16, 2018 Array BioPharma Inc. (Nasdaq: ARRY) reported that it will present data from the Phase 3 COLUMBUS trial of encorafenib and binimetinib in advanced BRAF-mutant melanoma in an oral presentation on June 4, 2018, at the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, Illinois (Press release, Array BioPharma, MAY 16, 2018, View Source [SID1234526780]).

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"Binimetinib and encorafenib is the first targeted therapy to demonstrate over 30 months median overall survival in a Phase 3 trial and we look forward to presenting the results from the COLUMBUS trial at ASCO (Free ASCO Whitepaper)," said Ron Squarer, Chief Executive Officer. "With nearly 15 months median progression-free survival and an attractive tolerability profile, these data underscore the potential of this combination to become an important new treatment option for patients with BRAF-mutant advanced, unresectable or metastatic melanoma."

As previously announced, the most common Grade 3/4 adverse events (AEs) seen in more than 5% of patients were increased gamma-glutamyltransferase (GGT) (9%), increased creatine phosphokinase (7%), and hypertension (6%) in the encorafenib plus binimetinib group.

Oral Presentation:

Title:

Overall Survival in COLUMBUS: A Phase 3 Trial of Encorafenib (ENCO) Plus Binimetinib (BINI) vs Vemurafenib (VEM) or ENCO in BRAF-Mutant Melanoma

Presenter:

Reinhard Dummer, M.D.

Abstract:

Abstract #223875/Publication #9504

Session:

Melanoma/Skin Cancers

Date:

Monday, June 4, 2018

Time:

9:12 a.m. – 9:24 a.m. Central Time (10:12 a.m. – 10:24 a.m. Eastern Time)

Location:

Arie Crown Theater

The abstract can be accessed through the ASCO (Free ASCO Whitepaper) website, View Source, beginning May 16, 2018, at 5:00 p.m. Eastern Time. Following the presentation on June 4, the slides will be available as a PDF on Array’s website at www.arraybiopharma.com.

Array will host an encore webcast presentation of the COLUMBUS trial data.

Encore Webcast:

Date:

Monday, June 4, 2018

Time:

11:15 a.m. Central Time (12:15 p.m. Eastern Time)

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

9615719

Webcast, including replay and conference call slides:View Source

About Melanoma
Metastatic melanoma is the most serious and life-threatening type of skin cancer and is associated with low survival rates. [1, 2] There are about 200,000 new cases of melanoma diagnosed worldwide each year, approximately half of which have BRAF mutations, a key target in the treatment of metastatic melanoma. [1, 3, 4]

About COLUMBUS
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 trial evaluating the efficacy and safety of the combination of encorafenib and binimetinib compared to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAFV600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the trial. Patients were randomized into two parts:

In Part 1, 577 patients were randomized 1:1:1 to receive the combination of encorafenib 450 mg daily and binimetinib 45 mg twice daily (COMBO450), encorafenib, 300 mg daily (ENCO 300), or vemurafenib, 960 mg twice daily alone. The dose of encorafenib in the combination arm is 50% higher than the single agent maximum tolerated dose of 300 mg. A higher dose of encorafenib was possible due to improved tolerability when combined with binimetinib. The primary endpoint for the COLUMBUS trial was an mPFS comparison of the COMBO450 arm versus vemurafenib. mPFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Central Review (BICR). Secondary endpoints include a comparison of the mPFS of COMBO450 arm to that of ENCO300 and a comparison of overall survival (OS) in patients treated in the COMBO450 arm to that of vemurafenib alone. Results from Part 1 of the COLUMBUS trial, previously published in The Lancet OncologyMay 2018, showed that COMBO450 more than doubled mPFS in patients with advanced BRAF-mutant melanoma, with a mPFS of 14.9 months compared with 7.3 months observed with vemurafenib [HR 0.54, (95% CI 0.41-0.71, p<0.0001)]. In the secondary mPFS comparison of COMBO450 to ENCO300, ENCO300 demonstrated a mPFS of 9.6 months [HR 0.75, (95% CI 0.56-1.00, p=0.051)].
In Part 2, 344 patients were randomized 3:1 to receive encorafenib 300 mg daily plus binimetinib 45 mg twice daily (COMBO300) or ENCO300. Part 2 was designed to provide additional data to help evaluate the contribution of binimetinib to the combination of encorafenib and binimetinib.
As the secondary endpoint comparison of mPFS between the COMBO450 arm and ENCO300 arm in Part 1 did not achieve statistical significance, the protocol specified analysis of OS is descriptive.

About Encorafenib and Binimetinib
BRAF and MEK are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers including melanoma and colorectal cancer. Encorafenib is a late-stage small molecule BRAF inhibitor and binimetinib is a late-stage small molecule MEK inhibitor, both of which target key enzymes in this pathway. Encorafenib and binimetinib are being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial and the Phase 3 BEACON CRC trial.

Array BioPharma has exclusive rights to encorafenib and binimetinib in the U.S. and Canada. Array has granted Ono Pharmaceutical exclusive rights to commercialize both products in Japan and South Korea and Pierre Fabre exclusive rights to commercialize both products in all other countries, including Europe, Asia and Latin America. Encorafenib and binimetinib are investigational medicines and are not currently approved in any country.

On May 16, 2018 Molecular Partners AG (SIX: MOLN), a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin therapies*, reported that the complete safety and efficacy results of the Phase 1 study of its lead proprietary oncology drug, MP0250, will be presented at the Annual Meeting 2018 of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago (Press release, Molecular Partners, MAY 16, 2018, View Source [SID1234526673]).

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MP0250 is a multi-DARPin candidate targeting simultaneously VEGF and HGF, two prominent escape pathways, and has the potential to reverse resistance that has built to standard of care cancer therapies. MP0250 is currently evaluated in a Phase 2 study in combination with bortezomib and dexamethasone in patients with relapsed refractory multiple myeloma. An additional Phase 1b/2 study will evaluate MP0250 in combination with osimertinib in patients with EGFR-mutated NSCLC (Non-small cell lung cancer).

The data to be presented at ASCO (Free ASCO Whitepaper) include the complete safety and efficacy results and pharmacokinetics data from the First-in Human Phase 1 study of MP0250 in advanced solid tumor patients.

"We are very pleased with the Phase 1 data of MP0250," commented Andreas Harstrick, Chief Medical Officer of Molecular Partners. "MP0250 was well tolerated and about half of the patients stayed on treatment for three months or longer, with the longest treatment duration beyond one year. We are looking forward to additional results from our Phase 2 combination studies."

The MP0250 data will be presented in the following sessions:

Monday, June 4, 2018, 8.00 am ET, Developmental Therapeutics – Clinical Pharmacology and Experimental Therapeutics / Abstract 2520 (Poster Board: #346):
First-in-class phase I study evaluating MP0250, a VEGF and HGF neutralizing DARPin molecule, in patients with advanced solid tumors (Azaro et al.)
Monday, June 4, 2018, 3:00 pm – 4:15 pm ET, room S406:
Discussion of the abstract at the Poster Discussion Session
Full details on the Molecular Partners’ session at ASCO (Free ASCO Whitepaper) 2018 as well as all presentations can be found here. Following its presentation at the ASCO (Free ASCO Whitepaper), the poster will also be available one the Molecular Partners website.

*DARPin is a registered trademark owned by Molecular Partners AG.

Financial Calendar
August 30, 2018 – Publication of 2018 Half-year Results
November 01, 2018 – Q3 2018 Management Statement
View Source

About the DARPin Difference
DARPin therapeutics are a new class of protein therapeutics opening an extra dimension of multi-specificity and multi-functionality. DARPin candidates are potent, specific, safe and very versatile. They can engage in more than 5 targets at once, offering potential benefits over those offered by conventional monoclonal antibodies or other currently available protein therapeutics. The DARPin technology is a fast and cost-effective drug discovery engine, producing drug candidates with ideal properties for development and very high production yields.
With their good safety profile, low immunogenicity and long half-life in the bloodstream and the eye, DARPin therapies have the potential to advance modern medicine and significantly improve the treatment of serious diseases, including cancer and sight-threatening disorders. Molecular Partners is partnering with Allergan to advance clinical programs in ophthalmology, and is advancing a proprietary pipeline of DARPin drug candidates in oncology. The most advanced global product candidate is abicipar, a molecule currently in Phase 3, in partnership with Allergan.
Several DARPin molecules for various ophthalmic indications are also in development. The most advanced systemic DARPin molecule, MP0250, is in Phase 1 clinical development for the treatment of solid tumors and in Phase 2 development for hematological tumors. In addition, Molecular Partners intends to further evaluate MP0250 for solid tumors in a phase 1b/2 trial for EGFR-mutated NSCLC. MP0274, the second-most advanced DARPin drug candidate in oncology, has broad anti-HER activity; it inhibits HER1, HER2 and HER3-mediated downstream signaling via Her2, leading to induction of apoptosis. MP0274 has moved into Phase 1. Molecular Partners is also advancing a growing preclinical pipeline that features several immuno-oncological development programs. DARPin is a registered trademark owned by Molecular Partners AG.

On May 16, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") reported that a wide selection of abstracts highlighting the Company’s diverse oncology portfolio across a broad range of cancers have been accepted for oral and poster presentation at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 1-5 in Chicago (Press release, Astellas Pharma US, MAY 16, 2018, View Source [SID1234526696]). Highlights of the data and studies being presented include findings for: men with non-metastatic Castration-Resistant Prostate Cancer (CRPC) taking enzalutamide* and androgen deprivation therapy; patients with locally advanced or metastatic urothelial cancer taking enfortumab vedotin**, an investigational antibody-drug conjugate (ADC); and patients taking gilteritinib in Phase 3 trial in FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).

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Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

"The Astellas abstracts accepted for presentation at this year’s ASCO (Free ASCO Whitepaper) meeting demonstrate the depth and breadth of our growing leadership in oncology across a broad range of cancers," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "These data demonstrate the strength and progress of our oncology pipeline driven by investment in R&D and collaborative partnerships."

The following will be presented during an oral presentation:

Title: (Abstract 4504) Updated Results from the enfortumab vedotin Phase 1 (EV-101) Study in Patients with Metastatic Urothelial Cancer (mUC)

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 3, 9:12 AM – 9:24 AM CDT
Oral Abstract Session: Genitourinary (Nonprostate) Cancer
Location: Arie Crown Theater
Additionally, the following data will be shared during poster presentations:

Title: (Abstract TPS4590) EV-201 Study: A Single-Arm, Open-Label, Multicenter Study of enfortumab vedotin for Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer who previously Received Immune Checkpoint Inhibitor Therapy

Presenter: Jonathan E. Rosenberg, MD

Session Date/Time: June 2, 8:00 AM – 11:30 AM CDT
Poster Session: Genitourinary (Nonprostate) Cancer
Location: Hall A
Title: (Abstract 5010) Health-Related Quality of Life (HRQoL) Deterioration and Pain Progression in Men with Non-Metastatic Castration-Resistant Prostate Cancer (M0-CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2, 1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Poster Discussion Session on June 2, 2018, 4:45 PM – 6:00 PM CDT, at S406
Title: (Abstract 5043) Association Between Health-Related Quality of Life (HRQoL) and clinical outcomes in non-metastatic castration-resistant prostate cancer (M0 CRPC): Results from the PROSPER study

Presenter: Gerhardt Attard, MD, PhD

Session Date/Time: June 2,1:15 PM – 4:45 PM CDT
Poster Session: Genitourinary (Prostate) Cancer
Location: Hall A
Title: (Abstract TPS7075) A Phase 3, Trial of Gilteritinib, as Maintenance Therapy after Allogeneic Hematopoietic Stem Cell Transplantation in Patients with FLT3-ITD + AML

Presenter: Mark J. Levis, MD, PhD

Session Date/Time: June 4, 8:00 AM – 11:30 AM CDT
Poster Session: Hematologic Malignancies—Leukemia, Myelodysplastic Syndromes, and Allotransplant
Location: Hall A
*Enzalutamide is developed through a collaboration between Pfizer and Astellas and commercialized under the brand name XTANDI.
**Enfortumab vedotin is developed through a collaboration between Seattle Genetics and Astellas

On May 16, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported that abstracts from two Phase 2 studies of indoximod, used in combination with other agents, are now available on the website of the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, NewLink Genetics, MAY 16, 2018, View Source [SID1234526712]). Presentation sessions and times are noted below. Additional data will be presented at ASCO (Free ASCO Whitepaper).

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Abstract 9512, Phase 2 trial of the IDO pathway inhibitor indoximod plus checkpoint inhibition for the treatment of patients with advanced melanoma, presented by Yousef Zakharia, MD, University of Iowa Hospitals and Clinics, Holden Comprehensive Cancer Center

Poster Session "Melanoma/Skin Cancers" – Poster Board #339 – Mon, Jun 4, 1:15PM – 4:45PM, McCormick Place, Hall A

Poster Discussion Session – Mon, Jun 4, 4:45PM – 6:00PM, McCormick Place, Rm E451

Abstract 4015, Phase 2 trial of the IDO pathway inhibitor indoximod plus gemcitabine / nab-paclitaxel for the treatment of patients with metastatic pancreas cancer, presented by Nathan Bahary, MD, PhD, University of Pittsburgh Medical Center Cancer Center Pavilion

Poster Session "Gastrointestinal (Noncolorectal) Cancer" – Poster Board #204 – Sun, Jun 3, 8:00AM – 11:30AM, McCormick Place, Hall A

Poster Discussion Session – Sun, Jun 3, 4:45PM – 6:00PM, McCormick Place, Hall D2

About Indoximod
Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including chemotherapy, radiation, checkpoint blockade and cancer vaccines across multiple indications such as AML, DIPG and melanoma.

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 [SID1234526746]). 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.