On June 12, 2026 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported top-line results from the Phase 3 LAGOON trial, conducted by PharmaMar, evaluating Zepzelca (lurbinectedin) in patients with relapsed (second-line) metastatic small cell lung cancer (SCLC). The trial did not meet its primary endpoint of overall survival (OS) evaluating Zepzelca as monotherapy or in combination with irinotecan compared to investigators’ choice of topotecan or irinotecan. No new safety signals were identified with Zepzelca monotherapy or in combination with irinotecan, and the overall safety profiles of the investigational arms were consistent with the known safety profile of each agent.

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"Relapsed SCLC is an aggressive cancer with a poor prognosis and patients continue to need treatment options, including in later lines of therapy. We thank the investigators, trial sites and patients who were involved in the LAGOON trial, along with our partner, PharmaMar," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development, and chief medical officer of Jazz Pharmaceuticals. "Zepzelca is an important treatment in SCLC and, based on the strength of the IMforte trial results, we believe its most beneficial use is in the first-line maintenance setting in combination with immunotherapy given the rapid progression of metastatic SCLC after first-line chemotherapy induction."

The full U.S. approval of Zepzelca in 2025 is based on the Phase 3 IMforte trial, which evaluated Zepzelca in combination with atezolizumab as first-line maintenance treatment for patients with extensive-stage SCLC. In the IMforte trial, the Zepzelca and atezolizumab combination demonstrated a statistically significant improvement in the primary endpoints of OS and progression-free survival (PFS), as assessed by an independent review facility, compared to treatment with atezolizumab alone. The Zepzelca and atezolizumab combination reduced the risk of disease progression or death by 46% and the risk of death by 27%, compared to atezolizumab maintenance therapy alone. The LAGOON results are distinct from the IMforte trial and do not impact Zepzelca’s approval in the first-line maintenance setting.

The company has shared the LAGOON results with the FDA and will discuss next steps with the agency regarding its post-marketing requirements for the Zepzelca second-line indication.

The study results do not impact the company’s 2026 guidance.

Key Results from the Phase 3 LAGOON Trial
The LAGOON trial included a broader patient population than the Phase 2 pivotal trial that supported the second-line accelerated approval, including patients with a history of CNS involvement. Efficacy of Zepzelca in the subset of patients without a history of CNS involvement was more comparable to the control arm, which performed better than historical precedent.

Trial Population

Zepzelca monotherapy
Median OS

Zepzelca + irinotecan
Median OS

Control
Median OS

HR (95% CI)
Zepzelca vs Control

HR (95% CI)
Zepzelca+irinotecan vs Control

Overall

8.7 (n=240)

10.9 (n=242)

10.7 (n=242)

1.190 (0.959, 1.476)

0.902 (0.729, 1.115)

Without CNS metastases

9.6 (n=182)

11.1 (n=189)

10.7 (n=186)

1.106 (0.875, 1.398)

0.922 (0.729, 1.166)

With CNS metastases

7.1 (n=58)

10.5 (n= 53)

10.3 (n=56)

1.791 (1.162, 2.760)

1.107 (0.724, 1.692)

The overall safety profile for Zepzelca was favorable relative to the control arm. Treatment-related adverse events (TRAE) were 78.5% with Zepzelca, 95% with Zepzelca + irinotecan, and 93.8% with the control arm. TRAEs Grade ≥ 3 were 35% with Zepzelca, 62.6% with Zepzelca + irinotecan, and 64.4% with the control arm.

About the LAGOON Trial
LAGOON (NCT05153239) is a Phase 3, randomized (1:1:1), multicenter, open-label clinical trial with three arms: one arm to receive lurbinectedin 3.2 mg/m2 as monotherapy (the approved dose in the U.S.), the second arm to receive lurbinectedin 2.0 mg/m2 in combination with irinotecan 75 mg/m2, and the third arm to receive topotecan or irinotecan based on the investigators’ choice. The trial was conducted in patients with SCLC, whose disease has progressed following prior platinum-containing chemotherapy with or without anti-PD-1 or anti-PD-L1 agents. The LAGOON trial enrolled 724 patients from more than 200 sites globally, including in the U.S., Canada and Europe. The trial is sponsored by Jazz’s partner, PharmaMar.

About Small Cell Lung Cancer
In the U.S., approximately 13 percent of lung cancers are small cell.1 Approximately 30,000 new cases of small cell lung cancer (SCLC) are reported in the U.S. each year.2 The risk for developing SCLC is much higher among current or former tobacco smokers; however, SCLC can also be caused by exposure to secondhand smoke, asbestos, some inhaled chemicals, radiation and air pollution. People with a family history of lung cancer may also be at a higher risk.3 SCLC is an aggressive form of lung cancer and it tends to spread quickly to other parts of the body including the brain, liver and bone.4,5 A large percentage of SCLC patients on treatment briefly achieve a response, although the cancer often returns and is usually more aggressive and resistant to regimens that were previously effective.6

About Zepzelca (lurbinectedin)
Zepzelca is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and potentially cell death.7

In October 2025, the FDA approved Zepzelca in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, as maintenance treatment for adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has not progressed after first-line induction therapy with atezolizumab or atezolizumab and hyaluronidase-tqjs, carboplatin and etoposide.

In June 2020, the FDA approved Zepzelca for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on ORR and DOR.

Important Safety Information for ZEPZELCA

Myelosuppression
ZEPZELCA can cause severe and fatal myelosuppression including febrile neutropenia and sepsis, thrombocytopenia and anemia.

Administer ZEPZELCA only to patients with baseline neutrophil count of at least 1,500 cells/mm3 and platelet count of at least 100,000/mm3. To reduce the risk of febrile neutropenia during treatment with ZEPZELCA in combination with atezolizumab or atezolizumab and hyaluronidase-tqjs, administer granulocyte colony-stimulating factor (G-CSF). Monitor blood counts including neutrophils, red blood cells and platelets prior to each ZEPZELCA administration. For neutrophil count less than 500 cells/mm3 or any value less than lower limit of normal, the use of G-CSF is recommended. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

ZEPZELCA with Intravenous Atezolizumab
In the IMforte study, primary prophylaxis of G-CSF was administered to 84% of patients. Based on laboratory values, decreased neutrophils occurred in 36%, including 18% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased neutrophil cells was 31 days and a median duration of 10 days. Febrile neutropenia occurred in 1.7%. Sepsis occurred in 1%. There were 7 fatal infections: pneumonia (n=3), sepsis (n=3), and febrile neutropenia (n=1).
Based on laboratory values, decreased platelets occurred in 54%, including 15% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased platelet cells was 31 days and a median duration of 12 days.
Based on laboratory values, decreased hemoglobin occurred in 51%, including 13% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. The median time to onset of Grade 3 and 4 decreased hemoglobin was 64 days and a median duration of 8 days.
ZEPZELCA as a Single Agent
In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent, Grade 3 or 4 neutropenia occurred in 41% of patients, with a median time to onset of 15 days and a median duration of 7 days. Febrile neutropenia occurred in 7% of patients. Sepsis occurred in 2% of patients and was fatal in 1% (all cases occurred in patients with solid tumors other than SCLC). Grade 3 or 4 thrombocytopenia occurred in 10%, with a median time to onset of 10 days and a median duration of 7 days. Grade 3 or 4 anemia occurred in 17% of patients.
Hepatotoxicity
ZEPZELCA can cause hepatotoxicity which may be severe.

Monitor liver function tests prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold, reduce the dose, or permanently discontinue ZEPZELCA based on severity.

ZEPZELCA with Intravenous Atezolizumab
In the IMforte study, based on laboratory values, increased alanine aminotransferase (ALT) occurred in 25%, including 3% Grade 3 or Grade 4 in patients who received ZEPZELCA in combination with atezolizumab. Increased aspartate aminotransferase (AST) occurred in 24% including 3% Grade 3 or Grade 4. The median time to onset of Grade ≥3 elevation in transaminases was 52 days (range: 6 to 337).
ZEPZELCA as a Single Agent
In clinical studies of 554 patients with advanced solid tumors receiving ZEPZELCA as a single agent, Grade 3 elevations of ALT and AST were observed in 6% and 3% of patients, respectively, and Grade 4 elevations of ALT and AST were observed in 0.4% and 0.5% of patients, respectively. The median time to onset of Grade ≥3 elevation in transaminases was 8 days (range: 3 to 49), with a median duration of 7 days.
Extravasation Resulting in Tissue Necrosis
Extravasation of ZEPZELCA can cause skin and soft tissue injury, including necrosis requiring debridement. Consider use of a central venous catheter to reduce the risk of extravasation, particularly in patients with limited venous access. Monitor patients for signs and symptoms of extravasation during the ZEPZELCA infusion. If extravasation occurs, immediately discontinue the infusion, remove the infusion catheter, and monitor for signs and symptoms of tissue necrosis. The time to onset of necrosis after extravasation may vary.

ZEPZELCA with Intravenous Atezolizumab

In the IMforte study, extravasation resulting in skin necrosis occurred in one patient who received ZEPZELCA in combination with atezolizumab.
Administer supportive care and consult with an appropriate medical specialist as needed for signs and symptoms of extravasation. Administer subsequent infusions at a site that was not affected by extravasation.

Rhabdomyolysis
Rhabdomyolysis has been reported in patients treated with ZEPZELCA.

Monitor creatine phosphokinase (CPK) prior to initiating ZEPZELCA and periodically during treatment as clinically indicated. Withhold or reduce the dose based on severity.

ZEPZELCA with Intravenous Atezolizumab

In the IMforte study, among 235 patients who had a creatine phosphokinase laboratory evaluation, increased creatine phosphokinase occurred in 9% who received ZEPZELCA in combination with atezolizumab.
Embryo-Fetal Toxicity
ZEPZELCA can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise female patients of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 7 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEPZELCA and for 4 months after the last dose.

Lactation
There are no data on the presence of ZEPZELCA in human milk, however, because of the potential for serious adverse reactions from ZEPZELCA in breastfed children, advise women not to breastfeed during treatment with ZEPZELCA and for 2 weeks after the last dose.

ADVERSE REACTIONS

ZEPZELCA with Intravenous Atezolizumab
Serious adverse reactions occurred in 31% of patients receiving ZEPZELCA in combination with atezolizumab. Serious adverse reactions occurring in >2% were pneumonia (2.5%), respiratory tract infections (2.1%), dyspnea (2.1%), and decreased platelet count (2.1%). Fatal adverse reactions occurred in 5% of patients receiving ZEPZELCA with atezolizumab including pneumonia (3 patients), sepsis (3 patients), cardio-respiratory arrest (2 patients), myocardial infarction (2 patients), and febrile neutropenia (1 patient).
The most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received ZEPZELCA with atezolizumab were decreased lymphocytes (55%), decreased platelets (54%), decreased hemoglobin (51%), decreased neutrophils (36%), nausea (36%), and fatigue/asthenia (32%).
ZEPZELCA as a Single Agent
Serious adverse reactions occurred in 34% of patients who received ZEPZELCA. Serious adverse reactions in ≥3% of patients included pneumonia, febrile neutropenia, neutropenia, respiratory tract infection, anemia, dyspnea, and thrombocytopenia.
The most common adverse reactions, including laboratory abnormalities, (≥20%) are leukopenia (79%), lymphopenia (79%), fatigue (77%), anemia (74%), neutropenia (71%), increased creatinine (69%), increased alanine aminotransferase (66%), increased glucose (52%), thrombocytopenia (37%), nausea (37%), decreased appetite (33%), musculoskeletal pain (33%), decreased albumin (32%), constipation (31%), dyspnea (31%), decreased sodium (31%), increased aspartate aminotransferase (26%), vomiting (22%), decreased magnesium (22%), cough (20%), and diarrhea (20%).
DRUG INTERACTIONS
Effect of CYP3A Inhibitors and Inducers

Avoid coadministration with a strong or a moderate CYP3A inhibitor (including grapefruit and Seville oranges) as this increases lurbinectedin systemic exposure which may increase the incidence and severity of adverse reactions to ZEPZELCA. If coadministration cannot be avoided, reduce the ZEPZELCA dose as appropriate.

Avoid coadministration with a strong CYP3A inducer as it may decrease systemic exposure to lurbinectedin, which may decrease the efficacy of ZEPZELCA.

GERIATRIC USE

ZEPZELCA with Intravenous Atezolizumab
Of the 242 patients with ES-SCLC treated with ZEPZELCA and atezolizumab in IMforte, 124 (51%) patients were 65 years of age and older, while 29 (12%) patients were 75 years of age and older. No overall differences in effectiveness were observed between older and younger patients. There was no overall difference in the incidence of serious adverse reactions in patients ≥65 years of age and patients <65 years of age (33% vs. 29%, respectively). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (45% vs. 31%, respectively).
ZEPZELCA as a Single Agent
Of the 105 patients with SCLC administered ZEPZELCA in clinical studies, 37 (35%) patients were 65 years of age and older, while 9 (9%) patients were 75 years of age and older. No overall difference in effectiveness was observed between patients aged 65 and older and younger patients.
There was a higher incidence of serious adverse reactions in patients ≥65 years of age than in patients <65 years of age (49% vs. 26%, respectively). The serious adverse reactions most frequently reported in patients ≥65 years of age were related to myelosuppression and consisted of febrile neutropenia (11%), neutropenia (11%), thrombocytopenia (8%), and anemia (8%). There was a higher incidence of Grade 3 or 4 adverse reactions in patients ≥65 years of age compared to younger patients (76% vs. 50%, respectively).
HEPATIC IMPAIRMENT
Avoid administration of ZEPZELCA in patients with severe hepatic impairment. If administration cannot be avoided, reduce the dose. Monitor for increased adverse reactions in patients with severe hepatic impairment.

Reduce the dose of ZEPZELCA in patients with moderate hepatic impairment. Monitor for increased adverse reactions in patients with moderate hepatic impairment.

No dose adjustment of ZEPZELCA is recommended for patients with mild hepatic impairment.

The full Prescribing Information for ZEPZELCA is available at: View Source

Zepzelca is a trademark of Pharma Mar S.A. used by Jazz Pharmaceuticals under license.

(Press release, Jazz Pharmaceuticals, JUN 12, 2026, View Source [SID1234666612])

On June 12, 2026 AbbVie (NYSE: ABBV) reported new Phase 3 data on a fixed-duration venetoclax-based combination at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress taking place June 11-14 in Stockholm, Sweden. Final results from the Phase 3 CLL14 trial in previously untreated chronic lymphocytic leukemia (CLL), which was conducted in collaboration with the German CLL Study Group, will be featured in an oral presentation.

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"The nine-year results from the landmark Phase 3 CLL14 trial affirm venetoclax’s enduring safety and efficacy," said Daejin Abidoye, vice president, therapeutic area head, oncology, solid tumor and hematology, AbbVie. "These data continue to add to the impressive body of evidence supporting the first-line use of venetoclax-based combination regimens in broader CLL patient populations, offering patients unprecedented time to next treatment — and therefore time off treatment — after one year of fixed-duration therapy. This research advances our mission to transform care and deliver better outcomes for patients living with difficult-to-cure blood cancers."

"Venetoclax in combination with obinutuzumab has shown positive responses across several key measures compared to obinutuzumab plus chlorambucil, including an extended increase in progression-free survival in previously untreated patients with chronic lymphocytic leukemia," said Kirsten Fischer, M.D., investigator in the CLL14 study, University Hospital Cologne. "Importantly, with a demonstrated median time to next treatment of approximately eight years, the findings reflect the sustained durability of this combination treatment option with a meaningful time without CLL specific treatment for patients."

A final analysis of the Phase 3 CLL14 trial, conducted in close collaboration with the German CLL Study Group, comparing venetoclax plus obinutuzumab to chlorambucil plus obinutuzumab in previously untreated patients with CLL and coexisting medical conditions, found that venetoclax plus obinutuzumab significantly improved progression-free survival (PFS) compared to chlorambucil plus obinutuzumab, providing a limited-duration treatment option for unfit patients with previously untreated CLL. The nine-year analysis demonstrated the long-term off-treatment efficacy and safety of the venetoclax plus obinutuzumab fixed-duration combination, with the median time to next treatment (TTNT) of 7.6 years.1

After a median follow-up of 9.2 years, treatment with venetoclax plus obinutuzumab resulted in superior PFS compared to the obinutuzumab plus chlorambucil group, with median PFS of 6.4 years versus 3.2 years, respectively (HR 0.50 [95% CI 0.39-0.63], p<0.001). The most frequently occurring Grade 3 (≥2%) adverse events (AEs) in patients receiving the venetoclax-based combination were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.1,2

CLL is one of the most common forms of leukemia in adults and is a type of cancer that can develop from cells in the bone marrow that later mature into certain white blood cells (called lymphocytes).3 Patients with CLL often experience relapsed disease, meaning the cancer has returned after previously responding to treatment, while others experience refractory disease when the cancer stops responding to therapy.4 While outcomes have improved in recent years, patients can often face long treatment durations and ongoing disease management challenges.

About the CLL14 Phase 3 Trial2,5,6,7

The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial (NCT02242942), which was conducted in close collaboration with the German CLL Study Group (GCLLSG), evaluated the efficacy and safety of a combined regimen of venetoclax and obinutuzumab (n=216) versus obinutuzumab and chlorambucil (n=216) in previously untreated patients with CLL and co-existing medical conditions (total Cumulative Illness Rating Scale [CIRS] score >6 or creatinine clearance <70 mL/min). The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated, according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. Efficacy was based on PFS, as assessed by an independent review committee.

Key secondary endpoints were rates of MRD in peripheral blood and bone marrow and overall and complete response rates.

In patients with CLL receiving venetoclax combination therapy with obinutuzumab, the most frequently occurring Grade 3 (≥2%) adverse events (AEs) were neutropenia, thrombocytopenia, infusion-related reaction, anemia, febrile neutropenia, pneumonia and leukopenia.1,2

About VENCLYXTO

VENCLYXTO (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTO targets the BCL-2 protein and works to help restore the process of apoptosis.

VENCLYXTO is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S. Together, the companies are committed to BCL-2 research and to studying venetoclax in clinical trials across several blood and other cancers. Venetoclax is approved in more than 80 countries, including the U.S.

VENCLYXTO (venetoclax) EU Indication and Summary of Important Safety Information

Venclyxto is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL):

in combination with acalabrutinib with or without obinutuzumab
in combination with obinutuzumab
in combination with ibrutinib
VENCLYXTO in combination with rituximab is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.

VENCLYXTO monotherapy is indicated for the treatment of CLL:

In the presence of 17p deletion or TP53 mutation in adult patients who are unsuitable for or have failed a B-cell receptor pathway inhibitor, or
In the absence of 17p deletion or TP53 mutation in adult patients who have failed both chemoimmunotherapy and a B-cell receptor pathway inhibitor
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Concomitant use of strong CYP3A inhibitors at initiation and during the dose-titration phase. Concomitant use of preparations containing St. John’s wort.

Special Warnings & Precautions for Use
Tumour lysis syndrome (TLS), including fatal events and renal failure requiring dialysis, has occurred in patients with CLL when treated with venetoclax. Venetoclax poses a risk for TLS at initiation and during the dose-titration phase. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. During post marketing surveillance, TLS, including fatal events, has been reported after a single 20 mg dose of venetoclax. The risk of TLS is a continuum based on multiple factors, including comorbidities (particularly reduced renal function), tumour burden, and splenomegaly in CLL. Patients should be assessed for risk and should receive appropriate prophylaxis, monitoring, and management for TLS.

Neutropenia (grade 3 or 4) has been reported and complete blood counts should be monitored throughout the treatment period. Serious infections, including sepsis with fatal outcome, have been reported. Monitoring of any signs and symptoms of infection is required. Suspected infections should receive prompt treatment and dose interruption or reduction, as appropriate. Live vaccines should not be administered during treatment or thereafter until B-cell recovery.

Drug Interactions
CYP3A inhibitors: For patients requiring concomitant use with venetoclax, refer to the SmPC for recommendations for managing drug-drug interactions. Patients should be monitored more closely for signs of toxicities and the dose may need to be further adjusted. Grapefruit products, Seville oranges, and starfruit (carambola) should be avoided during treatment with venetoclax.

Additional agents that may alter venetoclax plasma concentrations include P-gp or BCRP inhibitors, CYP3A inducers (including St. John’s wort), azithromycin and bile acid sequestrants. Concomitant use of these agents with venetoclax may require further dose adjustments and patients should be monitored closely for signs of toxicities.

Adverse Reactions
The most commonly occurring adverse reactions (≥20%) of any grade in patients receiving venetoclax in the combination studies with obinutuzumab, ibrutinib, or rituximab were diarrhoea, neutropenia, nausea, upper respiratory tract infection, fatigue and vomiting. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhoea, nausea, anaemia, fatigue, and upper respiratory tract infection.

The most frequently reported serious adverse reactions (≥2%) in patients receiving venetoclax in combination with obinutuzumab, ibrutinib, or rituximab were pneumonia, febrile neutropenia, sepsis, neutropenia, anaemia, diarrhoea and TLS. In the monotherapy studies, the most frequently reported serious adverse reactions (≥2%) were pneumonia and febrile neutropenia.

The most commonly occurring adverse reactions (≥20%) of any grade in patients treated with venetoclax in combination with acalabrutinib were infections, neutropenia, headache, bruising, diarrhoea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reaction (≥5%) was neutropenia.

The most commonly occurring adverse reactions of any grade (≥20%) in patients treated with venetoclax in combination with acalabrutinib and obinutuzumab were infections, neutropenia, headache, bruising, diarrhoea, nausea and musculoskeletal pain. The most commonly reported Grade ≥3 adverse reactions (≥5%) were neutropenia and thrombocytopenia.

Discontinuations, dosage reductions and dose interruptions due to adverse reactions have occurred in both venetoclax monotherapy and in combination therapy.

Special Populations
Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS at initiation and during the dose-titration phase. Venetoclax should be administered to patients with severe renal impairment (CrCl ≥15 ml/min and <30 ml/min) or end-stage renal disease (ESRD) requiring dialysis (CrCL <15ml/min) only if the benefit outweighs the risk and patients should be monitored closely for signs of toxicity due to increased risk of TLS.

For patients with severe hepatic impairment, a dose reduction of at least 50% throughout treatment is recommended. These patients should be monitored more closely for signs of toxicity.

Women should avoid becoming pregnant while taking venetoclax and for at least 30 days after ending treatment. Therefore, women of childbearing potential must use highly effective contraceptive measures while taking venetoclax and for 30 days after stopping treatment. Venetoclax may harm the foetus when administered to a pregnant woman. Breast-feeding should be discontinued during treatment with venetoclax.

(Press release, AbbVie, JUN 12, 2026, View Source [SID1234666611])

On June 12, 2026 Atossa Therapeutics, Inc. (Nasdaq: ATOS) ("Atossa" or the "Company"), a clinical-stage biopharmaceutical company developing novel therapies in oncology and other areas of high unmet clinical need, reported the closing of its previously announced registered direct offering of 1,363,637 shares (the "Shares") of its common stock, par value $0.18 per share ("Common Stock") (or common stock equivalents in lieu thereof), Series A warrants to purchase up to 1,363,637 shares of Common Stock and short-term Series B warrants to purchase up to 1,363,637 shares of Common Stock (such warrants, collectively, the "Series Warrants") and accompanying Series Warrants. The Series Warrants are exercisable six months following the date of issuance. The Series A warrants expire on the five and one-half (5.5) year anniversary of the date of issuance. The short-term Series B warrants expire on the two (2) year anniversary of the date of issuance.

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Rodman & Renshaw LLC acted as the exclusive placement agent for the offering.

The aggregate gross proceeds to the Company from the offering were approximately $4.5 million before deducting the placement agent’s fees and other estimated offering expenses payable by the Company. The potential additional gross proceeds to the Company from the Series Warrants, if fully exercised on a cash basis, will be approximately $12 million. No assurance can be given that any of the Series Warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the Series Warrants. The Company currently intends to use the net proceeds from the offering for clinical development of its product candidates, working capital and general corporate purposes.

The securities described above were offered and sold by the Company in a registered direct offering pursuant to a "shelf" registration statement on Form S-3 (File No. 333-279367) that was filed with the Securities and Exchange Commission (the "SEC"), on May 13, 2024, and declared effective by the SEC on May 23, 2024. The securities offered in the registered direct offering were offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying base prospectus relating to the registered direct offering were filed with the SEC and are available on the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying base prospectus may also be obtained from Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Atossa Therapeutics, JUN 12, 2026, View Source [SID1234666610])

On June 12, 2026 BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, reported new data from its foundational hematology franchise at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Stockholm. Updated results from tacabrutideg (BGB-16673), a potential best-in-class Bruton’s tyrosine kinase (BTK) degrader, demonstrated durable responses in pretreated relapsed/refractory (R/R) chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), with early activity also seen in BTK inhibitor–naïve patients. These data are complemented by results from the all-oral combination of BRUKINSA (zanubrutinib) plus next-generation BCL2 inhibitor BEQALZI (sonrotoclax; ZS), which continue to demonstrate rapid, deep, durable responses across multiple B-cell malignancies.

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Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said:
"BTK inhibition has reshaped the treatment of B-cell cancers, and we believe degradation is the next leap forward. At EHA (Free EHA Whitepaper), tacabrutideg is showing durable responses in heavily pretreated CLL, where patients have limited options, with early data suggesting potential in earlier lines of treatment. At the same time, the depth and consistency of responses we’re seeing with our ZS combination supports its potential to become the foundation of time-limited therapy, bringing us closer to a future where durable, treatment-free remission is possible. Together, these data reflect our ambition to define the next era of care in B-cell malignancies."

Updated CaDAnCe-101 data show durable responses with tacabrutideg in heavily pretreated R/R CLL/SLL and R/R WM (Oral Presentation: S152; June 14, 11:00 AM-12:15 PM CEST; Poster Presentation: PS2033; June 13, 2026, 6:45-7:45 PM CEST)
The oral presentation, which was selected for inclusion in the EHA (Free EHA Whitepaper) Press Program, will highlight data from 67 patients with R/R CLL/SLL treated with tacabrutideg across the different dose levels (50-500 mg), including patients with high-risk disease features (del(17p)/TP53 mutation, unmutated IGHV, complex karyotype, and BTK inhibitor resistance mutations). With a median study follow-up of 25.4 (range, 0.3-40.1) months, the analysis showed:

Overall response rate (ORR): 85.1%
Median time to first response (TTFR): 2.8 months (range, 2.0-19.4)
Median duration of response (DOR): 20.7 months (range, 0-27.6)
24-month progression-free survival (PFS) rate: 53.8% (95% CI, 38.8%-66.6%)
Safety: tacabrutideg was generally well tolerated in this heavily pretreated population with no treatment-related deaths and no new toxicities identified; patients with treatment response had rapid and sustained cytopenia improvement
In patients with R/R Waldenstrom macroglobulinemia (WM), tacabrutideg showed substantial responses in heavily pretreated patients, including those bearing BTK, CXCR4, and TP53 mutations, with major response rate (MRR) of 76.3% and very good partial response (VGPR) of 30.2% and a 15-month PFS rate of 70.4% (95% CI, 52.6-82.5) at a median PFS follow-up of 16.6 months.

Stephan Stilgenbauer, Professor of Medicine and Medical Director of the Comprehensive Cancer Center Ulm (CCCU), Head of the Early Clinical Trials Unit (ECTU), and Head of the Division of CLL Dept. of Internal Medicine III at Ulm University, said:
"Once patients with relapsed or refractory CLL progress after both BTK and BCL2 inhibitors, treatment options become extremely limited. In this study, tacabrutideg, which is designed to degrade BTK rather than inhibit it, achieved durable responses even in patients with high-risk clinical and biological characteristics, such as resistance mutations. These findings suggest a promising new approach for patients who currently have few effective therapies available."

First report of tacabrutideg in BTK inhibitor–naïve patients shows potential for improved efficacy in earlier treatment lines (Poster Presentation: PS1693; June 13, 2026, 6:45-7:45 PM CEST)
In the first clinical evaluation of tacabrutideg in patients who had not previously received a BTK inhibitor (N=54; CLL/SLL, n=29; mantle cell lymphoma [MCL], n=8; marginal zone lymphoma, n=10; Richter transformation, n=2; WM, n=5), tacabrutideg was well tolerated and showed promising and rapid antitumor activity. In 22 evaluable patients with CLL/SLL with median follow-up of 8.2 (range: 0.4-12.8) months, the study shows:

ORR: 86.4% Median TTFR: 2.8 (range, 2.7-5.6) months
At 6 months, none of the patients had progressed
Safety: tacabrutideg was generally well tolerated with no reported opportunistic infections, major hemorrhage or febrile neutropenia
Rapid, deep, and durable responses with ZS reinforce the potential to redefine time-limited treatment across CLL and MCL (Multiple Presentations)
Across multiple presentations at EHA (Free EHA Whitepaper) 2026, the all-oral ZS combination demonstrated rapid, deep, and durable responses across both treatment-naïve and relapsed/refractory settings. These data highlight the ability of ZS to drive high rates of undetectable minimal residual disease (uMRD) and sustained disease control regardless of risk factors reinforcing its potential to redefine expectations for fixed-duration, time-limited therapy in B-cell malignancies.

In treatment-naïve CLL (Oral Presentation: S145; June 12, 2026; 5:15-6:30 PM CEST):

ORR: 100%, with complete responses in 59.5% of patients
Best uMRD4 rate: 98.8%
No patient that achieved uMRD4 reverted to uMRD positivity
Best uMRD in patients with TP53 mutation/del(17p): 92.9% across 2 dose levels
Median time from combination start to uMRD4: 4.5 months
At a median follow-up of 34.1 months, no disease progression events were observed at the recommended Phase 2 dose of 320mg, including patients who electively discontinued therapy
In R/R CLL (Poster Presentation: PS1697; June 13, 2026, 6:45-7:45 PM CEST), at the 320mg (RP2D) of sonrotoclax:

ORR: 100%, with complete responses in 52% of patients
Best uMRD4 rate: 85%
No patient that achieved uMRD4 reverted to uMRD positivity
36-month PFS: 95.5% (95% CI, 83.2%-98.9%) across all dose cohorts at a median follow-up of 40.6 months (range, 10.2-60.6 months)
In R/R MCL (Poster Presentation: PF933; June 12, 2026, 6:45-7:45 PM CEST), at the 320mg (RP2D) of sonrotoclax:

ORR: 82%, with complete responses in 59% of patients
Median duration of response (DOR): not reached
30-mo DOR: 78.3% (95% CI, 51.3.%-91.4%)
About Tacabrutideg (BGB-16673)
With first-in-class and best-in-class potential, tacabrutideg is a foundational, orally administered Bruton’s tyrosine kinase (BTK) degrader. Tacabrutideg is the most advanced BTK degrader in the clinic with 1,200+ patients dosed to date in an extensive global clinical development program. This program includes three randomized Phase 3 trials in R/R CLL, including the head-to-head Phase 3 trial versus pirtobrutinib, which began enrolling in Q4 2025. Originating from BeOne’s chimeric degradation activation compound (CDAC) platform, tacabrutideg is designed to promote the degradation, or breakdown, of both wildtype and mutant forms of BTK, including those that commonly result in resistance to BTK inhibitors in patients who experience progressive disease.

The U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tacabrutideg for the treatment of adult patients with relapsed or refractory (R/R) chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL), and adult patients with R/R mantle cell lymphoma (MCL). Additionally, the European Medicines Agency (EMA) granted tacabrutideg PRIority MEdicines (PRIME) designation for the treatment of patients with Waldenstrom’s macroglobulinemia (WM) previously treated with a BTK inhibitor.

About BEQALZI (sonrotoclax)
BEQALZI (bee-KAHL-zee; sonrotoclax) is a foundational, next-generation and potentially best-in-class B-cell lymphoma 2 (BCL2) inhibitor with a unique pharmacokinetic and pharmacodynamic profile. Preclinical and clinical studies in early drug development have shown that sonrotoclax is a highly potent and specific BCL2 inhibitor with a short half-life and no drug accumulation. Sonrotoclax has shown promising clinical activity across a range of B-cell malignancies, including chronic lymphocytic leukemia (CLL), and is in development as a monotherapy and in combination with other therapeutics, including zanubrutinib. To date, more than 2,500 patients have been enrolled across the broad sonrotoclax global development program.

BEQALZI is approved by the U.S. Food and Drug Administration (FDA) and China’s National Medical Products Administration for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL), after at least two lines of systemic therapy, including a BTK inhibitor. It is also approved in China for adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have previously received at least one systemic therapy, including a BTK inhibitor.

About BRUKINSA (zanubrutinib)
BRUKINSA is an orally available, 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.

With the broadest label globally, BRUKINSA is the foundational BTK inhibitor and is the only BTK inhibitor to demonstrate superiority to another BTK inhibitor in a Phase 3 study. It is also the only BTK inhibitor to provide the flexibility of once or twice daily dosing.

The global BRUKINSA clinical development program includes more than 8,000 patients enrolled in over 30 countries and regions across more than 45 trials. BRUKINSA is approved in 80 markets in at least one indication, and more than 290,000 patients have been treated globally.

Select Important Safety Information for BEQALZITM (sonrotoclax)
Serious and sometimes fatal adverse reactions have occurred with BEQALZI, including tumor lysis syndrome (TLS), serious infections, neutropenia, and embryo-fetal toxicity. BEQALZI is contraindicated with strong CYP3A inhibitors at initiation and during the ramp-up phase due to the potential for an increased risk of tumor lysis syndrome.

In the safety population (N=115), tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up. Serious infections occurred in 14% of patients, and Grade 3 or 4 infections occurred in 17% (fatal: 2.6%), with pneumonia (10%) being the most common Grade 3 or greater infection. Grade 3 or 4 decreases in neutrophils occurred in 18% of patients (Grade 4: 6%), and febrile neutropenia occurred in 1.7% of all patients. The most common adverse reactions (≥15%) were pneumonia (16%) and fatigue (16%). The most common Grade 3–4 laboratory abnormalities (≥15%) were decreases in lymphocytes (29%) and neutrophils (18%).

Please see full Prescribing Information.

Select Important Safety Information for BRUKINSA
Serious adverse reactions, including fatal events, have occurred with BRUKINSA, including hemorrhage, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity (including drug-induced liver injury).

In the pooled safety population (N=1729), the most common adverse reactions (≥30%), including laboratory abnormalities, in patients who received BRUKINSA were neutrophil count decreased (51%), platelet count decreased (41%), upper respiratory tract infection (38%), hemorrhage (32%), and musculoskeletal pain (31%).

Please see full U.S. Prescribing Information including U.S. Patient Information.

The information provided in this press release is intended for a global audience. Product indications vary by region.

(Press release, BeOne Medicines, JUN 12, 2026, View Source [SID1234666609])

On June 12, 2026 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported preclinical data from its novel, potential best-in-class JAK2 V617F mutant-selective inhibitor in a poster presentation at the 2026 European Hematology Association (EHA) (Free EHA Whitepaper) Congress taking place in Stockholm, Sweden, June 11-14, 2026.

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"We’re encouraged by the preclinical data from our next-generation JAK2 program being presented at EHA (Free EHA Whitepaper) today," said Andrew Robbins, Cogent’s President and Chief Executive Officer. "This highly selective, potent inhibitor of JAK2 V617F has the potential to address the underlying mutational driver of disease while mitigating off-target hematological effects. We are rapidly advancing this program and remain on track to submit our Investigational New Drug application in 2026."

JAK2 V617F is the most prevalent molecular abnormality in BCR-ABL-negative myeloproliferative neoplasms (MPNs), occurring in approximately 95% of patients with polycythemia vera and 50% of patients with primary myelofibrosis or essential thrombocythemia. The poster highlights CGT1145, a potent inhibitor of the JAK2 V617F mutation with >100x selectivity over JAK2 WT and the JAK1/3 isoforms, along with high oral bioavailability and low clearance across species. CGT1145 has the potential to eradicate JAK2 V617F myeloproliferative neoplasm propagating cells and induce molecular remission with improved hematologic tolerability.

Cogent’s EHA (Free EHA Whitepaper) posters and presentation will be available on the company’s website at: View Source

(Press release, Cogent Biosciences, JUN 12, 2026, View Source [SID1234666608])