On April 24, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported its financial results for the first quarter of fiscal year 2024 (Press release, Chugai, APR 24, 2024, View Source [SID1234642276]).

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"Although revenue and profit decreased year on year due to the temporary impact of Ronapreve in the first quarter of 2024, the core business started off strong. In Japan, the sales of new products Phesgo and Vabysmo and a mainstay product Enspryng grew, but was notably impacted by the COVID-19 treatment Ronapreve, which its supply to the government has completed in the first quarter last year. As a result, domestic sales decreased by 46.4%. Overseas sales increased, with the substantial increase in exports of Hemlibra to Roche, despite the decrease in Actemra exports. In research and development, Piasky, our fifth global product, was approved in China and Japan. Currently, reviews for approval of the medicine are underway in other areas including the United States, Europe, and Taiwan. We aim to contribute to the treatment of paroxysmal nocturnal hemoglobinuria by providing a new option that improves convenience for patients affected by the disease, around the world. In addition, Alecensa was approved by the U.S. FDA for adjuvant treatment of ALK-positive non-small cell lung cancer. There are no other ALK inhibitors approved for this indication, bringing a new approach to patients. Regarding nemolizumab, another in-house project, development conducted by our out-licensing partners in Japan and overseas is making steady progress. In Japan, Mitchga as its product name was approved for the treatment of pruritus associated with atopic dermatitis in children aged 6 to 12 years, and for prurigo nodularis. Outside of Japan, the application was accepted by the U.S. and European authorities for the treatment of atopic dermatitis and prurigo nodularis. We will continue to drive forward the development of innovative medicines to provide new value to patients," said Dr. Osamu Okuda, Chugai’s President and CEO.

< First quarter results for 2024>

Chugai reported decreased revenue and operating profit year on year for the first quarter (Core-basis).

Regarding revenue, domestic sales decreased by 46.4% year on year. In the oncology field, although mature products such as Avastin were impacted by the NHI drug price revision and biosimilars, the overall decrease remained at 6.5% contributed by growth of new product Phesgo. In the specialty field, sales decreased by approximately 65%, mainly due to the completion of supply of Ronapreve to the government, which recorded ¥81.2 billion in the first quarter of last year, while our our new product Vabysmo grew and our mainstay product Enspryng performed well. Overseas sales increased year on year. Exports of Hemlibra increased by approximately 25%, exceeding the decrease in exports of Actemra. Other revenue increased substantially by approximately 60%, mainly driven by the increase in one-time income.

Cost to sales ratio improved by 16.3 percentage points year-on-year to 35.5%, mainly due to a change in the product mix. Research and development expenses increased mainly due to investments into drug discovery and early development, and increases associated with the progress of development projects. Selling, general and administration expenses remained at the same level as the previous year. Other operating income (expense) was ¥0.2 billion in income. As a result, Core operating profit totaled ¥102.1 billion (-3.1%).

Chugai also made good progress in research and development, in both early and late stages of developments, particularly in maximizing the value of in-house developed products and mainstay products. Regarding approvals, our fifth global product Piasky, a humanized anti-complement (C5) monoclonal antibody discovered by Chugai, has been approved for the first time in China for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), followed by approval in Japan. It is under review for PNH by other regulatory authorities, including in the United States, Europe, and Taiwan. Piasky is the second approved drug applying Chugai’s Recycling Antibody technology, following Enspryng. Another Chugai originated medicine, anti-IL-31RA, a humanized monoclonal antibody Mitchga (generic name: nemolizumab), has also been approved in Japan for additional indications including treatment for pruritus associated with atopic dermatitis (children aged ≥6 and <13 years) and prurigo nodularis (PN), only when existing treatment is insufficiently effective. Maruho, the out-license partner of nemolizumab in Japan has received these approvals. Additionally, Alecensa, which is also an in-house project, has been approved as an adjuvant therapy for ALK-positive non-small cell lung cancer, expanding its indication. As for projects in-licensed from Roche, Vabysmo, the only bispecific antibody in the ophthalmology field, has been approved for an additional indication for the treatment of macular edema associated with retinal vein occlusion. FoundationOne CDx Cancer Genomic Profile has been approved as companion diagnostics for three additional products, respectively.
Regarding filings, Chugai originated nemolizumab, developed by Galderma outside of Japan, has been accepted for review as a treatment for patients with PN and atopic dermatitis, by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For PN, priority review designation has been granted by the U.S. FDA. As for projects in-licensed from Roche, the anti-CD20xCD3 bispecific antibody mosunetuzumab has been filed in Japan for the treatment of patients with relapsed or refractory follicular lymphoma. Furthermore, regulatory applications have been submitted for Evrysdi and Tecentriq for additional indications for pre-symptomatic spinal muscular atrophy and alveolar soft part sarcoma, respectively.
In addition, Chugai has in-licensed zilebesiran from Roche for the treatment of hypertension with high cardiovascular risk, and started a clinical study in Japan for RG6299, an antisense oligonucleotide targeting complement factor B, for the treatment of IgA nephropathy.

[2024 first quarter results]

Billion JPY 2024
Jan – Mar 2023
Jan – Mar % change
Core results
　Revenue 236.9 312.2 -24.1%
　　Sales 204.5 291.5 -29.8%
　　Other revenue 32.5 20.7 +57.0%
　Operating profit 102.1 105.4 -3.1%
　Net income 76.0 78.4 -3.1%
IFRS results
　Revenue 236.9 312.2 -24.1%
　Operating profit 99.9 98.3 +1.6%
　Net income 74.4 73.5 +1.2%
[Sales breakdown]

Billion JPY 2024
Jan – Mar 2023
Jan – Mar % change
Sales 204.5 291.5 -29.8%
　Domestic sales 103.2 192.7 -46.4%
　　Oncology 56.1 60.0 -6.5%
　　Specialty 47.0 132.7 -64.6%
　Overseas sales 101.3 98.8 +2.5%
[Oncology field (Domestic) Top5-selling medicines]

Billion JPY 2024
Jan – Mar 2023
Jan – Mar % change
　Tecentriq 14.5 15.1 -4.0%
　Avastin 8.7 13.0 -33.1%
　Polivy 7.4 7.2 +2.8%
　Alecensa 6.6 6.6 -
　Perjeta 6.1 7.5 -18.7%
[Specialty field (Domestic) Top5-selling medicines plus Ronapreve]

Billion JPY 2024
Jan – Mar 2023
Jan – Mar % change
　Hemlibra 12.5 12.4 +0.8%
　Actemra 10.2 9.9 +3.0%
　Enspryng 5.8 4.7 +23.4%
　Vabysmo 4.0 3.0 +33.3%
　Evrysdi 3.4 3.0 +13.3%
　Ronapreve* - 81.2 -100.0%
*Ronapreve has not been listed in the National Health Insurance (NHI) price list.

[Progress in R&D activities from Feb 2nd, 2024 to Apr 24th, 2024]

2024 Q1 R&D Progress
About Core results

Chugai discloses its results on a Core basis from 2013 in conjunction with its decision to apply IFRS. Core results are the results after adjusting non-Core items to IFRS results. Chugai’s recognition of non-recurring items may differ from that of Roche due to the difference in the scale of operations, the scope of business and other factors. Core results are used by Chugai as an internal performance indicator, for explaining the underlying business performance both internally and externally, and as the basis for payment-by-results such as a return to shareholders.

Trademarks used or mentioned in this release are protected by law.

On April 24, 2024 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a clinical-stage oncology company developing MasterKey therapies that target families of oncogenic mutations in patients with cancer, reported forthcoming presentations during the 2024 ASCO (Free ASCO Whitepaper) Annual Meeting, taking place May 31 – June 4 in Chicago, IL (Press release, Black Diamond Therapeutics, APR 24, 2024, View Source [SID1234642275]). The two poster presentations describe data for BDTX-1535 in patients with recurrent glioblastoma (GBM) across two clinical trials: a Phase 1 dose escalation trial, for which topline data were released in December 2023, and a Phase 0/1 "trigger" ("window of opportunity") trial conducted as an Investigator Sponsored Trial at the Ivy Brain Tumor Center (NCT06072586).

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Presentation details are as follows:

Title: Phase 1 Study of BDTX-1535, an Oral 4th Generation Covalent EGFR Inhibitor, in Patients with Recurrent Glioblastoma: Preliminary Dose Escalation Results
Speaker/Author: Dr. Patrick Wen, Dana Farber Cancer Institute and Harvard Medical School
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2068
Poster: #367

Title: A Phase 0/1 ‘Trigger’ Trial of BDTX-1535 in Recurrent High-Grade Glioma (HGG) Patients with EGFR Alterations or Fusions
Speaker/Author: Yoshie Umemura, MD, BS, Ivy Brain Tumor Center and Barrow Neurological Institute
Date and Time: Saturday, June 1, 2024, 9:00 AM – 12:00 PM CDT
Abstract: 2069
Poster: #368

Posters will become available on June 1, 2024 at 10:00 AM EDT on the Black Diamond Therapeutics website here.

About BDTX-1535
BDTX-1535 is an oral, brain-penetrant MasterKey inhibitor of oncogenic epidermal growth factor receptor (EGFR) mutations in non-small cell lung cancer (NSCLC), including classical driver mutations, non-classical driver mutations, and the acquired resistance C797S mutation. BDTX-1535 is a fourth-generation tyrosine kinase inhibitor (TKI) that potently inhibits, based on preclinical data, more than 50 oncogenic EGFR mutations expressed across a diverse group of patients with NSCLC in multiple lines of therapy. Based on preclinical data, BDTX-1535 also inhibits EGFR extracellular domain mutations and alterations commonly expressed in glioblastoma (GBM) and avoids paradoxical activation observed with earlier generation reversible TKIs. A "window of opportunity" trial of BDTX-1535 in patients with GBM is ongoing (NCT06072586) and a Phase 2 trial is ongoing in patients with NSCLC (NCT05256290).

On April 24, 2024 Biogen Inc. (NASDAQ: BIIB) reported first quarter 2024 financial results (Press release, Biogen, APR 24, 2024, View Source [SID1234642274]). Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We are starting 2024 with an increase in earnings per share and solid execution across our new product launches along with the realization of meaningful cost savings and margin improvement. We see momentum building at a steady pace for LEQEMBI. In particular, we were encouraged that LEQEMBI in-market revenue for the first quarter nearly tripled sequentially and we saw a significant build in month-to-month new patient starts in the first quarter. As the launch progresses and infrastructure develops, we continue to believe in the potential longer-term commercial opportunity in Alzheimer’s disease. In rare disease, the U.S. launch of SKYCLARYS is advancing well and with the E.U. launch underway, we are beginning to realize the value of the Reata transaction. The uptake of ZURZUVAE in postpartum depression and QALSODY in SOD-1 ALS, two areas of significant unmet need, has also been encouraging. With a renewed culture focused on purpose and performance, we are advancing toward our goal of returning to sustainable growth while creating enhanced value for patients and our shareholders."
Financial Highlights
Q1 ’24 Q1 ’23 △
r (CC*)
Total Revenue (in millions) $2,290 $2,463 (7)% (7)%
GAAP diluted EPS $2.70 $2.67 1% —%
Non-GAAP diluted EPS $3.67 $3.40 8% —%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
* Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. Foreign currency revenue values are converted into U.S. Dollars using the exchange rates from the end of the previous calendar year.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q1 ’24 Q1 ’23 △
r (CC*)
Multiple sclerosis (MS) product revenue(1)
$1,076 $1,125 (4)% (4)%
Rare disease revenue(2)
$424 $443 (4)% (4)%
Biosimilars revenue $197 $192 2% 2%
Other product revenue(3)
$15 $2 538% 542%
Total product revenue $1,712 $1,763 (3)% (3)%
Revenue from anti-CD20 therapeutic programs $394 $399 (1)% (1)%
Contract manufacturing, royalty and other revenue $185 $300 (39)% (40)%
Total revenue $2,290 $2,463 (7)% (7)%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) Multiple sclerosis includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA.
(2) Rare disease includes SPINRAZA, QALSODY and SKYCLARYS.
(3) Other includes ADUHELM, FUMADERM and ZURZUVAE.
•First quarter 2024 ZURZUVAE revenue was approximately $12 million.
Expense Summary
(in millions) Q1 ’24 Q1 ’23 △
GAAP cost of sales*
$542 $663 18%
% of Total Revenue 24% 27%
Non-GAAP cost of sales*
$500 $663 25%
% of Total Revenue 22% 27%
GAAP R&D expense $453 $571 21%
Non-GAAP R&D expense $447 $571 22%
GAAP SG&A expense $582 $605 4%
Non-GAAP SG&A expense $569 $603 6%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
* Excluding amortization and impairment of acquired intangible assets

•There were no idle capacity charges in the first quarter of 2024. First quarter 2023 GAAP and Non-GAAP cost of sales includes approximately $45 million of idle capacity charges. The decrease in first quarter 2024 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in revenue from new product launches and decrease in contract manufacturing revenue, as well as less idle capacity charges.

•In the first quarter 2024 as compared to the first quarter of 2023, the decrease in GAAP R&D and SG&A expense of approximately $118 million and $24 million, respectively, and the decrease in Non-GAAP R&D and SG&A expense of approximately $124 million and $33 million, respectively, was primarily due to savings achieved from our Fit for Growth and R&D portfolio prioritization initiatives. First quarter 2023 GAAP and Non-GAAP SG&A expense includes approximately $31 million related to
2

the termination of the co-promotion agreement with Eisai for Biogen’s multiple sclerosis products in Japan.
Other Financial Highlights

•First quarter 2024 GAAP and Non-GAAP collaboration profit sharing was a net expense of $66 million, which includes $61 million related to Biogen’s collaboration with Samsung Bioepis, and $5 million to Sage Therapeutics related to the commercialization of ZURZUVAE in the U.S.

•First quarter 2024 GAAP other expense was $94 million, primarily driven by net interest expense and net unrealized losses on strategic equity investments of $31 million. First quarter 2024 Non-GAAP other expense was $63 million, primarily driven by net interest expense.

•First quarter 2024 GAAP and Non-GAAP effective tax rates were 15.4% and 15.9%, respectively. First quarter 2023 GAAP and Non-GAAP effective tax rates were 11.6% and 13.5%, respectively, and benefited from the resolution of an uncertain tax matter and higher non-cash tax benefits from changes in the value of our equity investments.
Financial Position

•First quarter 2024 net cash flow from operations was $553 million. Capital expenditures were $46 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was $507 million.

•As of March 31, 2024, Biogen had cash, cash equivalents, and marketable securities totaling approximately $1.1 billion and approximately $6.5 billion in total debt, resulting in net debt of approximately $5.5 billion. As of March 31, 2024 $750 million of the 2023 Term Loan which was put in place at the time of the Reata acquisition had been repaid, with the remaining $250 million expected to be repaid during the second quarter of 2024.

•Subsequent to the end of the first quarter of 2024, Biogen received its scheduled installment payment of approximately $437 million from Samsung BioLogics related to Biogen’s sale of its JV equity stake in Samsung Bioepis.

•No shares of the Company’s common stock were repurchased in the first quarter of 2024. As of March 31, 2024, there was $2.1 billion remaining under the share repurchase program authorized in October 2020.

•For the first quarter of 2024 the Company’s weighted average diluted shares were 146 million.

Full Year 2024 Financial Guidance

For the full year 2024, Biogen continues to expect a Non-GAAP diluted EPS guidance range as follows:
Reaffirmed Full Year 2024 Guidance
Non-GAAP diluted EPS
$15.00 to $16.00
Reflecting growth of ~5% at the mid-point*

*Versus reported full year 2023

While total revenue is expected to decline by a low- to mid-single digit percentage, Biogen continues to expect core pharmaceutical revenue, defined as product revenue plus Biogen’s 50% share of net LEQEMBI product revenue and cost of sales, including royalties, to be relatively flat for 2024 compared to 2023 as further declines in multiple sclerosis product revenue are expected to be offset by increases in revenue from new product launches.

Biogen continues to expect an improvement in the cost of sales as a percentage of total revenue for 2024 compared to 2023 driven by product mix and significantly lower idle capacity charges.

For 2024 compared to 2023, Biogen continues to expect operating income to grow at a low-double digit percentage. This is expected to be driven by improved cost of sales as a percentage of revenue, as well as lower operating expenses as a result of the Company’s Fit for Growth program.

This guidance also assumes that foreign exchange rates as of April 19, 2024, will remain in effect for the remainder of the year, net of hedging activities. Other modeling considerations will be provided on the conference call and webcast.

This financial guidance does not include any impact from potential acquisitions or large business development transactions or pending and future litigation, as all are hard to predict, or any impact of potential tax or healthcare reform. Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2024 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending or future significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the first quarter will be broadcast via the internet at 8:30 a.m. ET on April 24, 2024 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

On April 24, 2024 Bicycle Therapeutics plc (NASDAQ: BCYC), a biopharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported the acceptance of two abstracts for poster presentation at the 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place May 31-June 4 in Chicago (Press release, Bicycle Therapeutics, APR 24, 2024, View Source [SID1234642273]).

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Poster Presentation Details:

Title: Breaking from the paradigm of antibody-drug conjugates: Evaluation of clinical pharmacokinetics and safety of Bicycle Toxin Conjugates (BTCs)
Poster Session Title: Developmental Therapeutics – Molecularly Targeted Agents and Tumor Biology
Date and Time: Saturday, June 1, at 9 a.m. CT
Abstract Number: 3088
Speaker/Lead Author: Justin Bader, Pharm.D., MBA, Bicycle Therapeutics

Title: A phase 2/3 study of Bicycle Toxin Conjugate BT8009 targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC): Duravelo-2
Poster Session Title: Genitourinary Cancer – Kidney and Bladder
Date and Time: Sunday, June 2, at 9 a.m. CT
Abstract Number: TPS4619
Speaker/Lead Author: Yohann Loriot, M.D., Ph.D., Institut de Cancérologie Gustave Roussy, Université Paris-Saclay

The posters will be made available in the Publications section of bicycletherapeutics.com following the presentations.

On April 24, 2024 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global oncology company, reported it will share research outcomes from its broad hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, May 31 – June 4, 2024 (Press release, BeiGene, APR 24, 2024, View Source [SID1234642272]).

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"Our presentations at this year’s ASCO (Free ASCO Whitepaper) highlight the strength of our growing oncology portfolio and our commitment to developing treatments that address the unmet needs of patients with B-cell malignancies and solid tumors," Mehrdad Mobasher, M.D., M.P.H., Chief Medical Officer, Hematology at BeiGene. "The exciting data we will share during ASCO (Free ASCO Whitepaper) showcase BRUKINSA’s uniquely differentiated clinical profile and add to the growing body of evidence supporting its role across the blood cancer treatment paradigm."

BeiGene will share new data for BRUKINSA (zanubrutinib), which add to the robust efficacy and safety evidence differentiating it within the BTK class. Key highlights include:

A network meta-analysis comparing the efficacy of BRUKINSA vs acalabrutinib in patients with relapsed/refractory chronic lymphocytic leukemia (CLL); and
A post-hoc analysis from the Phase 3 ALPINE study of BRUKINSA vs ibrutinib evaluating the risk of developing hypertension based on the initiation and adjustment of antihypertensive medications.
Reflecting BeiGene’s growing solid tumor development program, TEVIMBRA (tislelizumab-jsgr) will be the subject of multiple presentations – as a monotherapy, in combination with chemotherapy agents, and as part of immunotherapy regimens across a range of tumor types. Key highlights include:

New data from the Phase 3 RATIONALE-306 study evaluating TEVIMBRA plus chemotherapy in patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC); and
Initial data from a first-in-human study evaluating HPK1 inhibitor BGB-15025 alone and in combination with TEVIMBRA.
"Our data at ASCO (Free ASCO Whitepaper) are a testament to the potential versatility of TEVIMBRA across a range of tumor types, and we are excited by the momentum of this critical pillar of our solid tumor development program," said Mark Lanasa, M.D., Ph.D., Chief Medical Officer, Solid Tumors at BeiGene. "During the meeting, we look forward to sharing a new analysis from our RATIONALE-306 study, which will provide insights into the three-year efficacy and safety of TEVIMBRA as a first-line treatment for ESCC."

BeiGene Presentations During ASCO (Free ASCO Whitepaper) 2024

Abstract Title

Abstract #

Presentation Details

Lead Author

Hematology

Comparative efficacy of Bruton tyrosine kinase inhibitors in the treatment of relapsed/refractory chronic lymphocytic leukemia: a network meta-analysis (NMA)

7048

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Real-world treatment patterns and outcomes of zanubrutinib in chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL)

11158

Session Type and Title: Poster Session – Quality Care/Health Services Research

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Krackeler

Risk of hypertension in patients with CLL/SLL who participated in ALPINE: a post hoc analysis

N/A

Online

D. Ramirez

Risk of new-onset hypertension in newly diagnosed chronic lymphocytic leukemia (CLL) patients (pts) treated with Bruton tyrosine kinase inhibitors (BTKi): A real-world data study using the Symphony Health Solution database

N/A

Online

T. Kou

Real-world treatment switching and sequencing to next line of therapy of zanubrutinib, acalabrutinib, and ibrutinib in CLL/SLL

N/A

Online

J. Pinilla-Ibarz

Real-world adherence and healthcare resource utilization of Bruton tyrosine kinase inhibitors (BTKi) in mantle cell lymphoma

N/A

Online

B. Shah

Comparison of zanubrutinib (zanu) and acalabrutinib (acala) in B-cell malignancies: an adverse event (AE)-based analysis

N/A

Online

T. Munir

Clinical and financial burden of mental health (MH) conditions in patients (pts) with low-grade non-Hodgkin lymphoma (LG-NHL)

7072

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

K. Yang

Real-world evaluation of treatment pattern, time to next treatment (TTNT), healthcare resource utilization (HCRU), and cost of care in follicular lymphoma (FL)

N/A

Online

S. Gaballa

Real-world Bruton tyrosine kinase inhibitor (BTKi) treatment patterns and outcomes among patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) in US community oncology practices

N/A

Online

J. Hou

BGB-11417-203, an ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia

TPS7090

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

H. Lee

CELESTIAL-TNCLL: An ongoing, open-label, multiregional, phase 3 study of sonrotoclax (BGB-11417) + zanubrutinib vs venetoclax + obinutuzumab for treatment-naïve (TN) CLL

TPS7087

Session Type and Title: Poster Session – Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Session Date and Time: June 3 at 9:00 AM-12:00 PM CDT

M. Shadman

Solid Tumor/IO

Global, randomized, phase III study of tislelizumab plus chemotherapy versus placebo plus chemotherapy as first-line treatment for advanced/metastatic esophageal squamous cell carcinoma (RATIONALE-306 update): minimum 3-year survival follow-up

4032

Session Type and Title: Poster Session – Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Session Date and Time: June 1 at 1:30-4:30 PM CDT

H. Yoon

BGB-A317-212: A multicenter, open-label, phase II study to evaluate the efficacy and safety of tislelizumab in combination with lenvatinib in patients with selected solid tumors

2610

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

L. Yufei

Preoperative (neoadjuvant) therapy with tislelizumab for locally advanced colorectal cancer with high microsatellite instability or deficient mismatch repair: an open-label, single-arm, multicenter phase II study

3599

Session Type and Title: Poster Session – Gastrointestinal Cancer—Colorectal and Anal

Session Date and Time: June 1 at 1:30-4:30 PM CDT

K. Ding

Tislelizumab First-Line (1L) Gastric/Gastroesophageal Junction Cancer (G/GEJ) Treatment Efficacy on PRO-Based Symptom Endpoints Adjusting for Informative Missing Data Bias: Results from RATIONALE 305

2605

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

D. Serrano

A first‑in‑human phase 1a dose‑escalation study of BGB‑15025 (HPK1 inhibitor) as monotherapy and in combination with tislelizumab (TIS; anti‑PD‑1 antibody) in patients (pts) with advanced solid tumors

2585

Session Type and Title: Poster Session – Developmental Therapeutics—Immunotherapy

Session Date and Time: June 1 at 9:00 AM-12:00 PM CDT

S. Deva

Long-term pooled safety analysis of tislelizumab as monotherapy or in combination with chemotherapy in patients with advanced cancers.

N/A

Online

C. Zhou

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared with other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease-relevant tissues.

Please see full U.S. Prescribing Information for BRUKINSA (zanubrutinib), including U.S. Patient Information or visit www.brukinsa.com.

About TEVIMBRA (tislelizumab-jsgr)
Tislelizumab is a uniquely designed humanized immunoglobulin G4 (IgG4) anti-programmed cell death protein 1 (PD-1) monoclonal antibody with high affinity and binding specificity against PD-1. It is designed to minimize binding to Fc-gamma (Fcγ) receptors on macrophages, helping to aid the body’s immune cells to detect and fight tumors.

Please see full U.S. Prescribing Information for TEVIMBRA (tislelizumab-jsgr), including Medication Guide.

About Sonrotoclax (BGB11417)
Sonrotoclax is an investigational small molecule B-cell lymphoma 2 (BCL2) inhibitor. It belongs to a class of BCL2 homology 3 (BH3) mimetics, and preclinical and IND-enabling studies have demonstrated potent activity and high selectivity of sonrotoclax against the antiapoptotic protein BCL2. Sonrotoclax is more potent and selective for BCL2 relative to BCLxL than venetoclax and shows the potential to overcome common BCL2 resistance mutations.