Two Datasets to be Introduced on the 2022 Annual Assembly
Poster Highlights Current Information from SORAYA Characterizing Anti-Tumor Exercise Voted for Better of ASCO® Program: Tumor Discount in 71.4% of Sufferers and Median Preliminary General Survival of 13.8 Months in Excessive Folate Receptor Alpha Sufferers with Platinum-Resistant Ovarian Most cancers
Information Collected from the Mirvetuximab Program on 464 Sufferers Present Completely different and Constant Security Profiles
ImmunoGen, Inc. (Nasdaq: IMGN), a pacesetter within the subject of prolonged antibody drug conjugate (ADC) for most cancers remedy, in the present day introduced extra efficacy knowledge from the landmark SORAYA examine evaluating mirvetuximab soravtansine (mirvetuximab) monotherapy in sufferers with folate receptor alpha (FRa)-ovarian most cancers. excessive platinum resistance beforehand handled with Avastin® (bevacizumab) and an built-in security abstract of single-agent mirvetuximab in a number of research in sufferers with FRa-positive recurrent ovarian most cancers. These findings can be highlighted in two posters on the 2022 American Society of Medical Oncology (ASCO) Annual Assembly, held June 3-7, 2022. Information from SORAYA has been chosen for Better of ASCO® Program.
“Remedy choices stay restricted for sufferers with platinum-resistant ovarian most cancers, notably for individuals who have obtained bevacizumab beforehand, and are related to low response charges, quick response period, and considerable toxicity,” says Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. âWe imagine these knowledge additional strengthen the potential of mirvetuximab to turn into the brand new customary of care on this inhabitants. With our biologic license software accepted and submitted by the FDA with Precedence Overview, we hope to carry mirvetuximab to sufferers with essentially the most urgent want later this 12 months. .”
CHARACTERIZATION OF ANTI-TUMOR ACTIVITIES IN THE STUDY OF SORAYA
SORAYA enrolled 106 platinum-resistant ovarian most cancers sufferers with excessive FRa expression who had been beforehand handled with 1 to three earlier systemic therapies, a minimum of one among which included bevacizumab. The first finish level was confirmed goal response charge (ORR) as assessed by the investigator. Secondary finish factors included investigator-assessed response period (DOR), CA-125 response, security and tolerability, progression-free survival (PFS), total survival (OS); ORR, DOR, and PFS with blinded impartial central assessment had been sensitivity analyzes. Information from SORAYA was first introduced on the 2022 Society of Gynecologic Oncology (SGO) Annual Assembly; The most recent evaluation to be introduced at ASCO relies on a 120-day deadline of April 29, 2022.
- The ORR by the investigator was 32.4% (95% confidence interval [CI]: 23.6%, 42.2%, together with 5 full responses. The median time to response was 1.5 months (vary 1.0 to five.6) and 71.4% of sufferers confirmed tumor discount.
- The illness management charge (DCR), outlined as full response (CR), partial response, or secure illness maintained for 12 weeks, was 51.4%.
- The median DOR was 6.9 months (95% CI: 5.6, 9.7) by investigators, with 5 respondents persevering with mirvetuximab on April 29, 2022.
- The median PFS assessed by investigators was 4.3 months (95% CI: 3.7, 5.2).
- The median baseline OS was 13.8 months, with 54% of the evaluated affected person inhabitants event-free.
- In a sensitivity evaluation with a blinded impartial central assessment, the outcomes had been comparable: ORR 30.2% (95% CI: 21.3%, 40.4%) with 6 CR; mDOR not achieved (95% CI: 5.0, NR); mPFS 5.5 months (95% CI: 3.8, 6.9).
- In respondents, depth and period of response didn’t look like affected by dose discount.
- Mirvetuximab is effectively tolerated, according to earlier research. The most typical treatment-related adversarial occasions (TRAE) included blurred imaginative and prescient (41% all grades, 6% grade 3+), keratopathy (29% all grades, 9% grade 3+), and nausea (29% all grades, 0% class 3+).
- TRAEs are usually resolved by supportive care or, if wanted, dose modification; discontinuation charge as a result of TRAEs was 9%.
- Kaplan-Meier plots for PFS and OS for inclusion within the poster.
“I imagine this extra evaluation from SORAYA additional helps the potential of mirvetuximab to be the primary biomarker-directed agent indicated for sufferers with platinum-resistant ovarian most cancers,” stated Ursula Matulonis, MD, Head of the Division of Gynecological Oncology on the Dana-Farber Most cancers Institute, Professor of Medication at Harvard Medical College, and Co-Principal Investigator of SORAYA. “The tumor discount noticed in additional than 70% of sufferers, together with the PFS curve and imply baseline total survival of 13.8 months, was spectacular. If accepted, I sit up for providing my sufferers mirvetuximab and persevering with to help additional developments. in sufferers with ovarian most cancers.”
SINGLE AGENT INTEGRATED SAFETY SUMMARY MIRVETUXIMAB SORAVTANSINE
This retrospective mixed evaluation included 464 sufferers with FRa-positive, recurrent ovarian most cancers in three research: the primary Part 1 human trial, the FORWARD I Part 3 trial, and the pivotal SORAYA Part 3 trial.
- Mirvetuximab monotherapy has a definite security profile consisting primarily of low-grade gastrointestinal and ocular occasions; unwanted effects are usually resolved and managed with supportive care and, if vital, dose modification. The discontinuation charge as a result of TRAE is 7%.
- The most typical TRAEs included blurred imaginative and prescient (42% all grades, 3% grade 3+), nausea (40% all grades, 2% grade 3+), diarrhea (33% all grades, 2% grade 3+), fatigue ( 31% all grade, 2% grade 3+), keratopathy (26% all grade, 3% grade 3+), and dry eye (22% all grade, 1% grade 3+).
- Mirvetuximab monotherapy didn’t trigger corneal ulceration or perforation, and not one of the sufferers had everlasting ocular sequelae.
- Nearly all of sufferers with ocular occasions don’t require dose delay or dose discount; <1% of sufferers discontinue mirvetuximab due to ocular occasions.
âAfter personally treating greater than 100 sufferers with mirvetuximab, I’ve helped my colleagues higher perceive tips on how to handle related ocular occasions,â stated Kathleen Moore, TSET Oklahoma Part I Program Director, Professor of Gynecological Oncology at The College of Oklahoma Faculty of Medication, and Principal Researcher MIRASOL. “With prevention and mitigation methods in place, sufferers who expertise ocular occasions can full their remedy, preserve their response, and don’t have any everlasting sequelae from these occasions. These knowledge show the distinct security profile of mirvetuximab and I sit up for potential approvals and ultimate releases. This 12 months.”
POSTER SESSION DETAILS
The next posters can be out there on Saturday, June 4th on the ASCO Assembly Library:
Title: Built-in Security Abstract of Mirvetuximab Soravtansine Single Agent in Sufferers with Folate A Receptor (FRa) Optimistic Recurrent Ovarian Most cancers: Part I and III Medical Trials
Foremost Creator: Kathleen N. Moore, MD
Date Time: June 4, 2022,14:15 â 17:15 EDT
Title: Mirvetuximab Soravtansine (MIRV) in Platinum Resistant Ovarian Most cancers Sufferers with Excessive Folate Receptor Alpha Expression (FRa): Characterization of Anti-Tumor Exercise within the SORAYA Examine
Foremost Creator: Ursula A. Matulonis, MD
Date Time: June 4, 2022,17:30 â 19:00 EDT
Extra info might be discovered at www.asco.org.
ABOUT MIRVETUXIMAB SORAVTANSINE
Mirvetuximab soravtansine (IMGN853) is a first-class ADC consisting of a folate receptor alpha-binding antibody, cleavage linker, and the maytansinoid cost DM4, a potent tubulin concentrating on agent, to kill focused most cancers cells.
ImmunoGen is creating the following technology of antibody-drug conjugates (ADCs) to enhance outcomes for most cancers sufferers. By producing focused therapies with enhanced anti-tumor exercise and favorable tolerability profiles, we intention to disrupt most cancers development and supply our sufferers a greater day. We name this our dedication to TARGET A BETTER NOW.
Study extra about who we’re, what we do, and the way we do it at www.immunogen.com.
Avastin® is a registered trademark of Genentech, a member of the Roche Group.
FORWARD THINKING STATEMENTS
This press launch consists of forward-looking statements. This assertion consists of, however will not be restricted to, ImmunoGen’s expectations relating to: the prevalence, timing and end result of potential preclinical, medical and regulatory occasions related to, and potential advantages from, the Firm’s potential merchandise, together with, however not restricted to, assessment Firm BLA to FDA for mirvetuximab and full approval of mirvetuximab, industrial launch of mirvetuximab and mirvetuximab’s potential to function a brand new customary of look after sufferers with platinum-resistant ovarian most cancers; in addition to the timing and presentation of preclinical and medical knowledge on the Firm’s potential merchandise. Varied components could trigger ImmunoGen’s precise outcomes to vary materially from these mentioned or implied within the forward-looking statements, and you’re cautioned to not rely unduly on these forward-looking statements, that are legitimate solely as of the date of this launch. Components that might trigger future outcomes to vary materially from these expectations embrace, however will not be restricted to: timing and outcomes of the Firm’s preclinical and medical improvement processes; inherent difficulties within the improvement of recent medicine, together with uncertainty relating to the timing, price, and outcomes of preclinical research, medical trials, and regulatory processes; the Firm’s means to help its product program financially; the time and end result of the Firm’s anticipated interactions with regulatory authorities; the dangers and uncertainties related to the size and period of the COVID-19 pandemic and the ensuing impression on the ImmunoGen business and enterprise; and different components as said within the Firm’s Annual Report on Type 10-Okay filed with the Securities and Alternate Fee on February 28, 2022, and different studies filed with the Securities and Alternate Fee. The forward-looking statements on this press launch are legitimate solely as of the date of this press launch. We’re below no obligation to replace any forward-looking statements, whether or not on account of new info, future developments or in any other case, besides as required by relevant regulation.
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