On April 17, 2020 Varian (NYSE: VAR) reported its second quarter fiscal year 2020 earnings release date (Press release, Varian Medical Systems, APR 17, 2020, View Source [SID1234556412]).

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The Company will report results for the second quarter of fiscal year 2020 after market close on Monday, May 4, 2020. The news release will be followed by a teleconference available to all interested at 1:30 p.m. Pacific Time. To access the teleconference call and replay:

Teleconference: Access from within the U.S. by dialing 1-877-869-3847, and from outside the U.S. by dialing 1-201-689-8261.

Replay: Access from within the U.S. by dialing 1-877-660-6853 and from outside the U.S. by dialing 1-201-612-7415 and enter conference ID 13700412. The teleconference replay will be available until 5:00 p.m. Pacific Time, Friday, May 8, 2020.

Webcast: To access the live webcast and replay, visit the company website at: www.varian.com/investors and click on the link for Second Quarter Earnings Results.

For automatic e-mail alerts regarding Varian news and events, investors can subscribe on the company website: View Source

On April 17, 2020 Incyte (Nasdaq:INCY) reported that the U.S. Food and Drug Administration (FDA) has approved Pemazyre (pemigatinib), a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test (Press release, Incyte, APR 17, 2020, View Source [SID1234556414]). Pemazyre is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response (DOR). Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s).

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"Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades"

"Our research into FGFR2 fusions or rearrangements in cholangiocarcinoma and the development of Pemazyre as the first targeted treatment option demonstrates our commitment to translating scientific discovery into solutions that can positively impact patients’ lives," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We’re proud to bring Pemazyre to patients and will make this new treatment available immediately."

The FDA approval was based on data from the FIGHT-202 study, a multi-center, open-label, single-arm study that evaluated Pemazyre as a treatment for adults with cholangiocarcinoma. In patients harboring FGFR2 fusions or rearrangements (Cohort A), Pemazyre monotherapy resulted in an overall response rate of 36% (primary endpoint), and median DOR of 9.1 months (secondary endpoint). Warnings and precautions for Pemazyre include eye problems such as dry or inflamed eyes, inflamed cornea, increased tears and a disorder of the retina; high levels of phosphate in the blood; and, for women who are pregnant, a risk of harm to the unborn baby or loss of pregnancy.

The FDA granted Pemazyre Breakthrough Therapy designation for the treatment of patients with previously treated advanced/metastatic or unresectable FGFR2 translocated cholangiocarcinoma. Additionally, the FDA granted Pemazyre Orphan Drug designation for the treatment of cholangiocarcinoma, and the New Drug Application (NDA) for Pemazyre was reviewed under the FDA’s Priority Review program.

"Although cholangiocarcinoma is considered a rare disease, it has been on the rise over the past three decades,"1,2 said Ghassan Abou-Alfa, M.D., Memorial Sloan Kettering Cancer Center. "It is encouraging to have a new targeted treatment option for patients who historically have had limited options after first-line chemotherapy or surgery, in which relapse rates remain high."

Cholangiocarcinoma is a rare cancer that forms in the bile duct. It is classified based on its anatomical origin: intrahepatic cholangiocarcinoma (iCCA) occurs in the bile duct inside the liver and extrahepatic cholangiocarcinoma occurs in the bile duct outside the liver. Patients with cholangiocarcinoma are often diagnosed at a late or advanced stage when the prognosis is poor.3,4 The incidence of cholangiocarcinoma varies regionally and ranges between 0.3-3.4 per 100,000 in North America and Europe.3 FGFR2 fusions or rearrangements occur almost exclusively in iCCA, where they are observed in 10-16% of patients.5-7 FGFRs play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating fusions, rearrangements, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

"Today’s approval of Pemazyre provides an exciting new treatment option for patients and will bring hope to those who typically face a difficult diagnosis journey and poor prognosis," said Stacie Lindsey, President, Cholangiocarcinoma Foundation.

Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Pemazyre have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a comprehensive program offering patient support, including financial assistance and ongoing education and resources to eligible patients. More information is available at Pemazyre.com.

The FDA is also expected to approve FoundationOneCDx as the companion diagnostic for Pemazyre. FoundationOne CDx is Foundation Medicine’s comprehensive genomic profiling assay and broad companion diagnostic platform approved for all solid tumors. If approved, this companion diagnostic would help identify patients with FGFR2 fusions or rearrangements who may be eligible for Pemazyre.

Conference Call Information

Incyte will host an investor conference call and webcast on Monday, April 20, 2020, at 8:00 a.m. ET. The webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or +1-201-389-0864 for international callers. When prompted, provide the conference identification number 13700772.

If you are unable to participate, a replay of the conference call will be available for 30 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is +1-201-612-7415. To access the replay, you will need the conference identification number 13700772.

About FIGHT-202

The FIGHT-202 Phase 2 multi-center, open-label, single-arm study (NCT02924376) evaluated the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement.

Patients were enrolled into one of three cohorts – Cohort A (FGFR2 fusions or rearrangements), Cohort B (other FGF/FGFR genetic alterations) or Cohort C (no FGF/FGFR genetic alterations). All patients received 13.5 mg Pemazyre orally once daily (QD) on a 21-day cycle (two weeks on/one week off) until radiological disease progression or unacceptable toxicity.

The primary endpoint of FIGHT-202 was overall response rate (ORR) in Cohort A, assessed by independent review per RECIST v1.1. Secondary endpoints include ORR in Cohorts B, A plus B, and C; and duration of response (DOR).

For more information about FIGHT-202, visit View Source

About FIGHT

The FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program includes ongoing Phase 2 and 3 studies investigating the safety and efficacy of Pemazyre therapy across several FGFR-driven malignancies. Phase 2 monotherapy studies include FIGHT-202, as well as FIGHT-201 investigating Pemazyre in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 mutations or fusions/rearrangements; FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 fusions/rearrangements; FIGHT-207 in patients with previously treated, locally-advanced/metastatic or surgically unresectable solid tumor malignancies harboring activating FGFR mutations or fusions/rearrangements, irrespective of tumor type. FIGHT-205 is a Phase 2 study investigating Pemazyre plus pembrolizumab combination therapy and Pemazyre monotherapy in patients with previously untreated, metastatic or unresectable bladder cancer harboring FGFR3 mutations or fusions/rearrangements who are not eligible to receive cisplatin. FIGHT-302 is a Phase 3 study investigating Pemazyre as a first-line treatment for patients with cholangiocarcinoma with FGFR2 fusions or rearrangements.

About Pemazyre (pemigatinib)

Pemazyre is a kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Pemazyre is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations.

Pemazyre is marketed by Incyte in the United States. Incyte has granted Innovent Biologics, Inc. rights to develop and commercialize pemigatinib in hematology and oncology in Mainland China, Hong Kong, Macau and Taiwan. Incyte has retained all other rights to develop and commercialize pemigatinib outside of the United States.

Additionally, Incyte’s marketing authorization application (MAA) seeking the approval of pemigatinib for patients with cholangiocarcinoma in the EU has been validated by the European Medicines Agency (EMA) and is currently under review for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that is relapsed or refractory after at least one line of systemic therapy.

Pemazyre is a registered trademark of Incyte Corporation.

Important Safety Information

Before you take PEMAZYRE, tell your healthcare provider about all of your medical conditions, including if you:

have vision or eye problems
have problems swallowing tablets
are pregnant or plan to become pregnant. PEMAZYRE can harm your unborn baby or cause loss of your pregnancy (miscarriage). You should not become pregnant during treatment with PEMAZYRE.
Females who can become pregnant:

Your healthcare provider should do a pregnancy test before you start treatment with PEMAZYRE.
You should use an effective method of birth control during treatment and for 1 week after your final dose of PEMAZYRE. Talk to your healthcare provider about birth control methods that may be right for you.
Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.
Males with female partners who can become pregnant:

You should use effective birth control when sexually active during treatment with PEMAZYRE and for 1 week after your final dose of PEMAZYRE.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment and for 1 week after your final dose of PEMAZYRE.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of PEMAZYRE?

PEMAZYRE may cause serious side effects, including:

Eye problems. Certain eye problems are common with PEMAZYRE but can also be serious. Eye problems include dry eye or inflamed eyes, inflamed cornea (front part of the eye), increased tears, and a disorder of the retina (an internal part of the eye). You will need to see an eye specialist for a complete eye exam before you begin treatment with PEMAZYRE, every 2 months for the first 6 months, and then every 3 months during treatment with PEMAZYRE.
You should use artificial tears or substitutes, hydrating or lubricating eye gels as needed, to help prevent or treat dry eyes.
Tell your healthcare provider right away if you develop any changes in your vision during treatment with PEMAZYRE, including: blurred vision, flashes of light, or see black spots. You may need to see an eye specialist right away.
High phosphate levels in your blood (hyperphosphatemia). Hyperphosphatemia is common with PEMAZYRE but can also be serious. Your healthcare provider will check your blood phosphate levels during treatment with PEMAZYRE.
Your healthcare provider may prescribe changes in your diet or phosphate lowering therapy, or change, interrupt, or stop PEMAZYRE if needed.
Tell your healthcare provider right away if you develop any muscle cramps, or numbness or tingling around your mouth.
The most common side effects of PEMAZYRE include:

hair loss
diarrhea
nails separate from the bed or poor formation of the nail
feeling tired
change in sense of taste
nausea
constipation
mouth sores
dry eyes
dry mouth
decrease in appetite
vomiting
joint pain
stomach-area (abdominal) pain
low phosphate in blood
back pain
dry skin
These are not all the possible side effects of PEMAZYRE. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Incyte Medical Information at 1-855-463-3463.

General information about the safe and effective use of PEMAZYRE.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use PEMAZYRE for a condition for which it is not prescribed. Do not give PEMAZYRE to other people, even if they have the same symptoms you have. It may harm them. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information that is written for healthcare professionals. Keep PEMAZYRE and all medicines out of the reach of children.

On April 16, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific antibodies (mAb2), reported the publication in Clinical Cancer Research of preclinical data highlighting the potential novel mechanism of action of its wholly-owned lead clinical asset FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody (Press release, F-star, APR 16, 2020, View Source;1 [SID1234556384]).

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FS118 is currently in a Phase 1 study in patients with late-stage solid tumors who have relapsed following prior successful PD-(L)1 therapy.

Despite advances with therapies targeting the highly immuno-suppressive molecules PD-1 (programmed cell death protein 1) or its ligand, PD-L1, many cancer patients are refractory to, or relapse following treatment. Relapse is associated with upregulation of other checkpoint inhibitor receptors such as LAG-3 (Lymphocyte Activation Gene 3). FS118 was selected for development based on its ability to overcome immunosuppression mediated by both LAG-3 and PD-L1 in cancer patients.

The in vitro and in vivo studies reported in Clinical Cancer Research demonstrated that FS118 simultaneously bound LAG-3 and PD-L1 with high affinity. FS118 showed a greater enhancement in T cell activity, and reversal of LAG-3 and PD-L1 immunosuppression, than the combination of the single component parts of the bispecific antibody. The authors concluded that targeting both LAG-3 and PD-L1 in a single tetravalent bispecific antibody can work synergistically to overcome inhibition of T cell activation.

In tumor mouse models, a bispecific antibody targeting LAG-3/PD-L1 significantly suppressed tumor growth. The anti-tumor immune response was greater than using PD-L1 or LAG-3 antibody monotherapy and was also more effective than a combination of those monotherapies. These data demonstrated that a LAG-3/PD-L1 targeting tetravalent bispecific antibody can provide dual blockade of LAG-3 and PD-L1 in vivo and can enhance the anti-tumor immune response.

The authors concluded that the study demonstrated a benefit from FS118, not observed with the combination of single PD-L1 and LAG-3 monoclonal antibodies, to drive a potent anti-tumor response, supporting the further development of FS118 for the treatment of patients with cancer.

Neil Brewis, Chief Scientific Officer of F-star, said: "These data are the foundation for our confidence in FS118 and its potential to overcome cancer immune resistance. Currently only the minority of patients realize durable benefit from immunotherapy, so there remains a huge need to develop more effective options. At F-star we are developing antibodies with an innovative tetravalent bispecific format and the potential to elicit better biological responses compared to traditional antibodies or combinations. We believe FS118, with its novel approach to overcoming resistance to PD-(L)1 blockade will be an important part of the exciting next wave of checkpoint therapies. We look forward to providing additional data from our ongoing Phase I study to validate our approach later this year."

A link to the full study, entitled "FS118, a bispecific antibody targeting LAG-3 and PD-L1 utilises a novel mechanism to enhance T cell activation resulting in potent anti-tumor activity" can be found here.

About FS118

Currently in a Phase 1 study at four clinical sites in the United States, FS118 is a potentially first-in-class medicine for the treatment of resistant and refractory cancer. This tetravalent, bispecific antibody is developed to overcome tumor evasion mechanisms promoted by two highly immuno-suppressive molecules: LAG-3 (Lymphocyte-Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1). By simultaneously blocking both inhibitory pathways, FS118 has preclinically demonstrated a potent anti-tumor growth activity as well as a highly differentiated mechanism of action when compared to checkpoint monotherapies alone or in combinations. In April 2018, a Phase 1 clinical study started in patients who have relapsed following a prior PD-(L)1-containing therapy. Information about the trial is available on clinicaltrials.gov NCT03440437. FS118 is manufactured at 2000L scale using standard mAb manufacturing processes.

On April 16, 2020 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the first patient was successfully dosed in a Phase 1/2a clinical trial of AFM24, a first in human study evaluating AFM24 as monotherapy in patients with advanced solid malignancies whose disease has progressed after treatment with previous anticancer therapies (Press release, Affimed, APR 16, 2020, View Source [SID1234556400]). AFM24, a tetravalent, bispecific epidermal growth factor receptor (EGFR)- and CD16A-binding innate cell engager, is novel due to its activation of innate immunity to kill solid tumors, inducing both antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as compared to other therapies that rely heavily on signal or checkpoint inhibition.

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"Today is a landmark day for Affimed and, more importantly, for patients whose solid tumors continue to progress," said Dr. Adi Hoess, Chief Executive Officer of Affimed. "This major milestone marks the first time a patient with solid tumors has been dosed with an innate cell engager. AFM24 has demonstrated preclinically the ability to bridge NK cells and macrophages to EGFR-expressing tumor cell lines, and to induce lysis through ADCC and ADCP, respectively, independent of RAS mutational status. We look forward to the continued study of this novel agent and further validating its safety and efficacy through this human clinical trial."

"Initiation of dosing in the first in human clinical trial of AFM24 is exciting news for the broad set of patients with hard to treat EGFR-expressing cancers," said Dr. Anthony El-Khoueiry, Phase I program director at the USC Norris Comprehensive Cancer Center and Keck School of Medicine, and principal investigator for the study. "While available EGFR therapies have improved the lives of patients, new therapeutic options are needed that are broadly efficacious, easier for patients to tolerate and can also address the issue of resistance associated with currently available treatments."

The study is an open-label, non-randomized, multi-center, multiple ascending dose escalation/expansion study to evaluate AFM24 as monotherapy in adult patients with advanced solid malignancies known to be EGFR-positive. The aim of the dose escalation phase is the determination of the maximum tolerated dose and the establishment of a recommended Phase 2a dose. The dose expansion phase is intended to collect preliminary evidence of efficacy and to further confirm the safety of AFM24. For more information including eligibility criteria, visit www.clinicaltrials.gov, using Identifier NCT04259450.

About AFM24
AFM24 is a tetravalent, bispecific EGFR- and CD16A-binding innate cell engager generated from Affimed’s fit-for-purpose ROCK platform. AFM24 uses the cytotoxic potential of the innate immune system by redirecting and activating NK cells and macrophages to kill EGFR-positive cancer cells through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), respectively. Due to its unique mechanism of action, AFM24 is potentially not limited to patient subtypes based on mutational status. Treatment of cynomolgus monkeys with AFM24 showed a favorable safety profile, even when the animals were treated at high dose levels, demonstrating AFM24’s potential to have lower toxicities in humans compared to other EGFR-targeted therapies.

On April 16, 2020 ImmunoGen, Inc., (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the Company will host a conference call at 8:00 a.m. ET on Friday, May 1, 2020 to discuss its first quarter operating results (Press release, ImmunoGen, APR 16, 2020, View Source [SID1234556385]). Management will also provide a brief update on the business.

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Conference Call Information

To access the live call by phone, dial (877) 621-5803; the conference ID is 7796220. The call may also be accessed through the Investors and Media section of the Company’s website, www.immunogen.com. Following the call, a replay will be available at the same location.