Ariela Noy MD

My colleague at the AIDS Malignancy Consortium has done a tremendously successful project which should have major impact. FOR IMMEDIATE RELEASE Thursday, October 7, 2021 ...Continue reading

FDA grants accelerated approval to zanubrutinib for marginal zone lymphoma On September 14, 2021, the Food and Drug Administration granted accelerated approval to zanubrutinib (Brukinsa, BeiGene) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. Approval is based on two open-label, multicenter, single-arm trials: BGB-3111-214 (NCT03846427), which evaluated 66 patients with MZL who received at le...ast one prior anti-CD20-based therapy, and BGB-3111-AU-003 (NCT02343120), which included 20 patients with previously treated MZL. Zanubrutinib was administered orally at 160 mg twice daily or 320 mg once daily. The efficacy measures were overall response rate (ORR) and duration of response (DoR), as assessed by an independent review committee using the 2014 Lugano criteria. In the first trial, the CT-based ORR was 56% (95% CI: 43%, 68%), with 20% achieving complete responses (CR). In the second trial, the ORR was 80% (95% CI: 56%, 94%), with a CR rate of 20%. The median DoR was not estimable; the estimated 1-year rate of DoR was 85% (95% CI: 67, 93) and 72% (95% CI: 40, 88), respectively. The most common adverse reactions (30%) to zanubrutinib include decreased neutrophil count, upper respiratory tract infection, decreased platelet count, hemorrhage, decreased lymphocyte count, rash, and musculoskeletal pain. Serious adverse reactions occurred in 40% of patients with MZL, most often from pyrexia and pneumonia. The prescribing information includes warnings and precautions for hemorrhage, infections, cytopenias, second primary malignancies, and cardiac arrythmias. The recommended zanubrutinib dosage is 160 mg orally twice daily or 320 mg orally once daily until disease progression or unacceptable toxicity.

from Dr. Craig Thompson, making us all proud: Given the evidence of the efficacy of the available COVID-19 vaccines, when a COVID-19 vaccine Emergency Use Authorization is converted to full FDA approval, MSK will make COVID-19 vaccination mandatory for all employees. We have already implemented this policy among our new hires, volunteers, and vendors who, since July 1, have been required to provide proof of vaccination before coming onsite. In all cases, qualifying individuals, including MSK staff, may request a medical or religious exemption.

I’ll be on this panel tomorrow discussing diffuse large B cell lymphoma. I’m not sure what the registration is but MXH21AN gets you a 35% registration discount. The meeting agenda is all day but my section is from 1020 till 1105

here is the link to Thursday's (July 1st). NPR show where I am the guest talking about https://www.wxxinews.org//connections-why-are-people-who-a

Hi, I will be on a live NPR show on July 1 at 1 pm talking about HIV and cancer trials. https://www.wxxinews.org/programs/connections

On April 23, 2021, the Food and Drug Administration approved loncastuximab tesirine-lpyl (Zynlonta, ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma. Approval was based on LOTIS-2 (NCT03589469)...Continue reading

Nice MSK news to share. Cynthia McCollum and Mini Kamboj Honored as Women of Distinction Published 3/26/2021 New York State Assembly Member Rebecca A. Seawright held the 6th Annual New York State Women of Distinction Awards Ceremony on March 23, 2021. Cynthia McCollum, Senior Vice President, Hospital Administration, and Mini Kamboj, MD, Chief Medical Epidemiologist, were both honored at this virtual event held in recognition of Women’s History Month. The award presented by S...tate Assembly Member Seawright was given to women who have demonstrated commitment to inspiring others and working hard to put their community on a better path forward. As well as being an award winner, Ms. McCollum served as this year's keynote speaker. Assembly Member Seawright honored 28 recipients with the Women of Distinction Award, each of whom helped make a difference in the Upper East Side, Yorkville, and Roosevelt Island communities throughout 2020. Assembly Member Seawright acknowledged Ms. McCollum’s long-standing commitment to MSK and her work in the community. Dr. Kamboj was recognized for her clinical and scholarly work in healthcare epidemiology and prevention of hospital acquired infections in cancer patients. I am honored to have been recognized with this award and to have given the keynote address. Women’s History Month is the perfect time to celebrate the progress women have made in our community, said Ms. McCollum. Today at MSK, women are represented in all levels of leadership within the organization and that is a wonderful achievement. I am incredibly honored to be the recipient of this award, said Dr. Kamboj. My hope is to inspire the next generation of female clinicians and researchers so they can reach their greatest potential in their pursuit of scientific excellence. "We celebrate women today who are exemplary change-makers and influencers and the pioneers of the past upon whose shoulders we stand," Assembly Member Seawright said. "They all inspire us to resist and keep up the fight. To the Women of Distinction, we say congratulations. You are an enduring inspiration to our entire community, our beloved city, and our great state of New York."

Partnership with New York City to Distribute Vaccines As part of our commitment to support equitable access to COVID-19 vaccines, MSK has partnered with New York City’s Department of Health to distribute COVID-19 vaccinations to communities that have been disproportionately impacted by the pandemic. Beginning Friday April 2, MSK will staff a COVID-19 vaccine clinic at the Abyssinian Baptist Church at 132 W. 138th Street in Harlem. The clinic will need to be staffed from 9:00am 5:00pm, Tuesday Saturday, through at least the month of April.

Complete game changer for patients with follicular. http://bit.ly/3kOyKnb

The Department of Medicine awarded a research grant to our study "Axicabatagene ciloleucel in HIV-associated diffuse large B cell lymphoma and high-grade B cell lymphoma." We hope to have the study open to accrual within a few months.

MSK licensed product to Juno. Many years of hard work by my outstanding colleagues from the lab to bedside. Congratulations! this On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLB...CL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B. Lisocabtagene maraleucel is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy. It consists of autologous T cells that are genetically modified to produce a CAR protein, allowing the T cells to identify and eliminate CD19-expressing normal and malignant cells. Efficacy was evaluated in TRANSCEND (NCT02631044), a single-arm, open label, multicenter trial that evaluated lisocabtagene maraleucel, preceded by lymphodepleting chemotherapy, in adults with R/R large B-cell lymphoma after at least two lines of therapy. Of the 192 patients evaluable for response, the overall response rate (ORR) per independent review committee assessment was 73% (95% CI: 67, 80) with a complete response (CR) rate of 54% (95% CI: 47, 61). The median time to first response was one month. Of the 104 patients who achieved CR, 65% had remission lasting at least 6 months and 62% had remission lasting at least 9 months. The estimated median duration of response (DOR) was not reached (95% CI: 16.7 months, NR) in patients who achieved a CR. The estimated median DOR among patients with partial response was 1.4 months (95% CI: 1.1, 2.2). Cytokine release syndrome (CRS) occurred in 46% of patients (Grade 3 or higher, 4%) and neurologic toxicity occurred in 35% (Grade 3 or higher, 12%). Three patients had fatal neurologic toxicity. Other Grade 3 or higher adverse reactions included infections (19%) and prolonged cytopenias (31%). FDA approved lisocabtagene maraleucel with a Risk Evaluation and Mitigation Strategy because of the risk of fatal or life-threatening CRS and neurologic toxicities. The recommended regimen is a single dose containing 50 to 110 x 106 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components, administered by IV infusion and preceded by fludarabine and cyclophosphamide for lymphodepletion. Lisocabtagene maraleucel is not indicated for the treatment of patients with primary central nervous system lymphoma.

FDA grants accelerated approval to umbralisib for marginal zone lymphoma and follicular lymphoma On February 5, 2021, the Food and Drug Administration granted accelerated approval to umbralisib (Ukoniq, TG Therapeutics), a kinase inhibitor including PI3K-delta and casein kinase CK1-epsilon, for the following indications: Adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based regimen; Adult patients with... relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Approval was based on two single-arm cohorts of an open-label, multi-center, multi-cohort trial, UTX-TGR-205 (NCT02793583), in 69 patients with MZL who received at least one prior therapy, including an anti-CD20 containing regimen, and in 117 patients with FL after at least 2 prior systemic therapies. Patients received umbralisib 800 mg orally once daily until disease progression or unacceptable toxicity. Efficacy was based on overall response rate (ORR) and duration of response (DOR) using modified 2007 International Working Group criteria assessed by an independent review committee. For patients with MZL, the ORR was 49% (95% CI: 37.0, 61.6) with 16% achieving complete responses. Median DOR was not reached (95% CI: 9.3, NE) in these patients. For patients with FL, the ORR was 43% (95% CI: 33.6, 52.2) with 3% achieving complete responses. Median DOR was 11.1 months (8.3, 16.4). The most common (>15%) adverse reactions, including laboratory abnormalities, were increased creatinine, diarrhea-colitis, fatigue, nausea, neutropenia, transaminase elevation, musculoskeletal pain, anemia, thrombocytopenia, upper respiratory tract infection, vomiting, abdominal pain, decreased appetite, and rash. Serious adverse reactions occurred in 18% of patients, most often from diarrhea-colitis and infection. Diarrhea-colitis and transaminase elevation were the most common reasons for dose modifications. The prescribing information provides warnings and precautions for adverse reactions including infections, neutropenia, diarrhea and non-infectious colitis, hepatotoxicity, and severe cutaneous reactions. The recommended umbralisib dose is 800 mg taken orally once daily with food until disease progression or unacceptable toxicity.

Pembroluzimab will now be available as second line therapy for Hodgkin lymphoma in the right setting. https://www.fda.gov//fda-extends-approval-pembrolizumab-cl. https://ascopubs.org//abs/10.1200/JCO.2020.38.15_suppl.8005

not my patient, but nice to see a little love at MSK. Go RNs and PCTs! https://www.nytimes.com//hospital-staff-turned-wedding-pla

Guest editor and comment for the Lancet HIV and Lancet Hematology: https://www.thelancet.com//PIIS2352-3018(20)30227/fulltext https://www.thelancet.com//HIV-related-haematological-mali... 196 international attendees for today's webinar. Thank you to the Lancet and my colleagues who wrote papers and participated in the webinar!

FDA Grants Accelerated Approval to Tafasitamab-cxix for Diffuse Large B-cell Lymphoma On July 31, 2020, the Food and Drug Administration granted accelerated approval to tafasitamab-cxix (MONJUVI, MorphoSys US Inc.), a CD19-directed cytolytic antibody, indicated in combination with lenalidomide for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible ...for autologous stem cell transplant. The efficacy of tafasitamab-cxix with lenalidomide was evaluated in L-MIND (NCT02399085), an open label, multicenter single-arm trial in 81 patients. Patients received tafasitamab-cxix 12 mg/kg intravenously with lenalidomide (25 mg orally on days 1 to 21 of each 28-day cycle) for maximum of 12 cycles, followed by tafasitamab-cxix as monotherapy. Efficacy was based on best overall response rate (ORR), defined as complete and partial responders and response duration, as assessed by an independent review committee. The best ORR in 71 patients with a diagnosis of DLBCL confirmed by central pathology was 55% (95% CI: 43%, 67%), with complete responses in 37% and partial responses in 18% of patients. Median response duration was 21.7 months (range: 0, 24). The most common adverse reactions (20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite. The recommended tafasitamab-cxix dose is 12 mg/kg as an intravenous infusion. View full prescribing information for MONJUVI. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s) This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 6 weeks ahead of the FDA goal date. This application was granted priority review, fast track, breakthrough, and orphan product designation. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics

FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed with mantle cell lymphoma (MCL) who have not responded to or who have relapsed following other kinds of treatment. Tecartus, a chimeric antigen receptor (CAR) T cell therapy, is the first cell-based gene therapy approved by th...Continue reading