On May 29, 2026 Johnson & Johnson (NYSE:JNJ) reported updated results from the Phase 1/1b CHRYSALIS-2 study evaluating intravenous RYBREVANT (amivantamab-vmjw) in combination with LAZCLUZE (lazertinib) in patients with advanced non-small cell lung cancer (NSCLC) with atypical epidermal growth factor receptor (EGFR) mutations. The analysis showed encouraging long-term outcomes with RYBREVANT plus LAZCLUZE in this difficult-to-treat population. Median overall survival, a secondary endpoint, was nearly 3.5 years.1 The primary endpoint of objective response rate was previously reported.2 These results add to the growing body of evidence demonstrating the potential of RYBREVANT plus LAZCLUZE to deliver durable survival outcomes across both common and atypical EGFR-mutated advanced NSCLC in the first-line setting. Data were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Abstract #8501).1

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Significant unmet need in patients with atypical EGFR-mutated NSCLC

Patients with atypical EGFR-mutated NSCLC tend to have poorer outcomes than those with common EGFR mutations (exon 19 deletions and L858R substitutions), and effective first-line treatment options remain limited.3,4 These mutations represent approximately 10-20 percent of all EGFR-mutated cases.5 Median overall survival with current standard of care single-agent therapies remains under two years, highlighting a significant unmet need for treatments that can deliver more durable benefit in this setting.6,7 RYBREVANT is designed to dual target EGFR and mesenchymal-epithelial transition (MET), while engaging the immune system.8,9,10,11 These complementary mechanisms play a central role in tumor growth and treatment resistance and may help address the underlying drivers of disease.

Expert and company perspectives supporting the strength of RYBREVANT plus LAZCLUZE

"For patients with non-small cell lung cancer harboring atypical EGFR-mutations, first-line treatment decisions are often clouded by uncertainty regarding the efficacy of currently available EGFR tyrosine kinase inhibitors," said Joel Neal,* M.D., Ph.D., principal investigator of the Phase 1/1b CHRYSALIS-2 study. "The responses we’ve seen in this trial suggest the potential for more durable disease control, and the overall survival data reinforce that picture. These long-term outcomes begin to change how we think about treatment options in managing this subtype of lung cancer." Neal is also a Professor of Medicine in the Division of Oncology at Stanford Medicine.

"Disease progression and molecular resistance remain critical barriers in EGFR-mutated non-small cell lung cancer," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "RYBREVANT-based combinations demonstrate the power of changing the biology by addressing multiple disease drivers from the start rather than relying on single-pathway strategies. With strong outcomes across all known EGFR mutations, this approach is raising the bar for what first-line treatment can achieve."

Detailed CHRYSALIS-2 study results

In Cohort C of the CHRYSALIS-2 study, RYBREVANT plus LAZCLUZE was evaluated as a first-line treatment in patients with atypical EGFR-mutated advanced NSCLC, excluding EGFR exon 20 insertion mutations (n=49). The most common atypical EGFR mutations included G719X (55 percent), S768X (27 percent) and L861X (24 percent), with 35 percent of patients harboring multiple atypical mutations. The study previously reported an objective response rate of 57 percent (primary endpoint).1,2

Median overall survival with RYBREVANT plus LAZCLUZE reached nearly 3.5 years (41.0 months; 95 percent confidence interval [CI], 27.7-not estimable) at a median follow-up of 31.3 months. Overall survival rates were 55 percent at three years and 46 percent at four years.1

Consistent clinical activity was observed across atypical EGFR mutation subgroups, as well as across patient and disease characteristics such as central nervous system metastases and TP53 status. Patients were also able to remain on treatment long-term across mutation groups and baseline characteristics. Notably, 41 percent of patients remained on RYBREVANT for two years or longer, further supporting the durable survival observed with this combination.1

The safety profile of RYBREVANT plus LAZCLUZE was consistent with previous reports, with no new safety signals observed with longer follow-up. Most adverse events were Grade 1 or 2. The most common treatment-emergent adverse events occurring in more than 30 percent of patients included paronychia (78 percent), rash (65 percent), hypoalbuminemia (61 percent) and infusion-related reactions (61 percent).1

RYBREVANT-based regimens are approved for patients with EGFR-mutated advanced NSCLC across common (exon 19 deletions and exon 21 L858R substitution mutations) and exon 20 insertion mutations, including in the first-line setting.12 These results further define long-term outcomes with first-line RYBREVANT plus LAZCLUZE for patients with atypical EGFR mutations. Additional data being presented at ASCO (Free ASCO Whitepaper) 2026 in lung, head and neck, and colorectal cancers underscore the broader potential of RYBREVANT across tumor types.

About the CHRYSALIS-2 Study

CHRYSALIS-2 (NCT04077463) is an open-label Phase 1/1b study to evaluate the safety and pharmacokinetics of LAZCLUZE, a third-generation EGFR-TKI, as monotherapy or in combinations with RYBREVANT, a human bispecific EGFR and cMet antibody in participants with advanced NSCLC. The study enrolled 460 patients with advanced NSCLC.13

Cohort C of the ongoing CHRYSALIS-2 study evaluates patients with atypical EGFR-mutated advanced NSCLC, excluding exon 20 insertion and classical EGFR mutations, who are treatment-naïve or have received up to two prior lines of therapy. Patients received intravenous RYBREVANT in combination with LAZCLUZE administered orally once daily.13

About Non-Small Cell Lung Cancer

Worldwide, lung cancer is one of the most common cancers, with NSCLC making up 80 to 85 percent of all lung cancer cases.14,15 The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma, and large cell carcinoma.16 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase controlling cell growth and division.17 EGFR mutations are present in 10 to 15 percent of Western patients with NSCLC with adenocarcinoma histology and occur in 40 to 50 percent of Asian patients.14,15,18,19,20,21 EGFR ex19del or EGFR L858R mutations are the most common EGFR mutations.22 The five-year survival rate for all people with advanced NSCLC and EGFR mutations treated with EGFR tyrosine kinase inhibitors (TKIs) is less than 20 percent.23,24 EGFR exon 20 insertion mutations are the third-most prevalent activating EGFR mutation.25 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of eight percent in the frontline setting, which is worse than patients with EGFR ex19del or L858R mutations, who have a real-world five-year OS of 19 percent.26

About RYBREVANT

RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj) received U.S. FDA approval in December 2025 and is approved in multiple markets worldwide for the treatment of adults with EGFR-mutated non-small cell lung cancer (NSCLC), including those with exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 insertion mutations. It is the only subcutaneous therapy approved in these populations and can be used as monotherapy or in combination with LAZCLUZE (lazertinib) or chemotherapy in the front- and second-line settings, offering convenient monthly† or bi-weekly dosing. RYBREVANT FASPRO is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

RYBREVANT (amivantamab-vmjw), administered intravenously, received U.S. FDA approval in March 2024 and is approved for the same indications as RYBREVANT FASPRO across multiple markets. RYBERVANT is a first-in-class, fully human bispecific antibody targeting EGFR and MET, designed to inhibit tumor growth while engaging the immune system.

The effectiveness of RYBREVANT FASPRO is supported by the established clinical profile of RYBREVANT, including data from multiple Phase 3 studies such as MARIPOSA, which demonstrated improvements in progression-free and overall survival when used in combination with LAZCLUZE in first-line advanced EGFR-mutated NSCLC.

The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology (NCCN Guidelines)‡ 27 include amivantamab-vmjw (RYBREVANT) across its FDA-approved treatment settings, including as a Category 1 preferred option in combination with lazertinib (LAZCLUZE) for first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. Subcutaneous amivantamab and hyaluronidase-lpuj (RYBREVANT FASPRO) may be substituted for IV amivantamab-vmjw (RYBREVANT) where appropriate. See the latest NCCN Guidelines for NSCLC for complete information.§ ||

The NCCN Guidelines for Central Nervous System Cancers also include amivantamab (RYBREVANT)-based regimens, including in combination with lazertinib (LAZCLUZE), as the only NCCN-preferred combination options for patients with EGFR-mutated NSCLC and brain metastases.§ ||

Beyond NSCLC, RYBREVANT-based therapies are being investigated across other solid tumors, including head and neck and colorectal cancers.

The legal manufacturer for RYBREVANT is Janssen Biotech, Inc. For more information, visit www.rybrevanthcp.com.

About LAZCLUZE

In 2018, Janssen Biotech, Inc., entered into a license and collaboration agreement with Yuhan Corporation for the development of LAZCLUZE (marketed as LECLAZA in South Korea). LAZCLUZE is an oral, third-generation, brain-penetrant EGFR TKI that targets both the T790M mutation and activating EGFR mutations while sparing wild-type EGFR. An analysis of the efficacy and safety of LAZCLUZE from the Phase 3 LASER301 study was published in The Journal of Clinical Oncology in 2023.28

The legal manufacturer for LAZCLUZE is Janssen Biotech, Inc. and Yuhan Corporation.

INDICATIONS

RYBREVANT (amivantamab-vmjw) is indicated:

in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.
in combination with carboplatin and pemetrexed for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.
in combination with carboplatin and pemetrexed for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA-approved test.
as a single agent for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, as detected by an FDA approved test, whose disease has progressed on or after platinum-based chemotherapy.
IMPORTANT SAFETY INFORMATION FOR RYBREVANT FASPRO AND RYBREVANT 12,29

CONTRAINDICATIONS

RYBREVANT FASPRO is contraindicated in patients with known hypersensitivity to hyaluronidase or to any of its excipients.

WARNINGS AND PRECAUTIONS

Hypersensitivity and Administration-Related Reactions with RYBREVANT FASPRO

RYBREVANT FASPRO can cause hypersensitivity and administration-related reactions (ARR); signs and symptoms of ARR include dyspnea, flushing, fever, chills, chest discomfort, hypotension, and vomiting. The median time to ARR onset is approximately 2 hours.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade ARR occurred in 13% of patients, including 0.5% Grade 3. Of the patients who experienced ARR, 89% occurred with the initial dose (Week 1, Day 1).

Premedicate with antihistamines, antipyretics, and glucocorticoids and administer RYBREVANT FASPRO as recommended. Monitor patients for any signs and symptoms of administration-related reactions during injection in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt RYBREVANT FASPRO injection if ARR is suspected. Resume treatment upon resolution of symptoms or permanently discontinue RYBREVANT FASPRO based on severity.

Infusion-Related Reactions with RYBREVANT

RYBREVANT can cause infusion-related reactions (IRR) including anaphylaxis; signs and symptoms of IRR include dyspnea, flushing, fever, chills, nausea, chest discomfort, hypotension, and vomiting. The median time to IRR onset is approximately 1 hour.

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), IRRs occurred in 63% of patients, including Grade 3 in 5% and Grade 4 in 1% of patients. IRR-related infusion modifications occurred in 54%, dose reduction in 0.7%, and permanent discontinuation of RYBREVANT in 4.5% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population (n=281), IRRs occurred in 50% of patients including Grade 3 (3.2%) adverse reactions. IRR-related infusion modifications occurred in 46%, and permanent discontinuation of RYBREVANT in 2.8% of patients.

RYBREVANT as a Single Agent

In CHRYSALIS (n=302), IRRs occurred in 66% of patients. IRRs occurred in 65% of patients on Week 1 Day 1, 3.4% on Day 2 infusion, 0.4% with Week 2 infusion, and were cumulatively 1.1% with subsequent infusions. 97% were Grade 1-2, 2.2% were Grade 3, and 0.4% were Grade 4. The median time to onset was 1 hour (range: 0.1 to 18 hours) after start of infusion. IRR-related infusion modifications occurred in 62%, and permanent discontinuation of RYBREVANT in 1.3% of patients.

Premedicate with antihistamines, antipyretics, and glucocorticoids and infuse RYBREVANT as recommended. Administer RYBREVANT via a peripheral line on Week 1 and Week 2 to reduce the risk of IRRs. Monitor patients for signs and symptoms of IRRs in a setting where cardiopulmonary resuscitation medication and equipment are available. Interrupt infusion if IRR is suspected. Reduce the infusion rate or permanently discontinue RYBREVANT based on severity. If an anaphylactic reaction occurs, permanently discontinue RYBREVANT.

Interstitial Lung Disease/Pneumonitis

RYBREVANT FASPRO and RYBREVANT can cause severe and fatal interstitial lung disease (ILD)/pneumonitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, ILD/pneumonitis occurred in 6% of patients, including Grade 3 in 1%, Grade 4 in 1.5%, and fatal cases in 1.9% of patients. 5% of patients permanently discontinued RYBREVANT FASPRO and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with LAZCLUZE

In MARIPOSA, ILD/pneumonitis occurred in 3.1% of patients, including Grade 3 in 1.0% and Grade 4 in 0.2% of patients. There was one fatal case of ILD/pneumonitis and 2.9% of patients permanently discontinued RYBREVANT and LAZCLUZE due to ILD/pneumonitis.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ILD/pneumonitis occurred in 2.1% of patients with 1.8% of patients experiencing Grade 3 ILD/pneumonitis. 2.1% discontinued RYBREVANT due to ILD/pneumonitis.

RYBREVANT as a Single Agent

In CHRYSALIS, ILD/pneumonitis occurred in 3.3% of patients, with 0.7% of patients experiencing Grade 3 ILD/pneumonitis. Three patients (1%) permanently discontinued RYBREVANT due to ILD/pneumonitis.

Monitor patients for new or worsening symptoms indicative of ILD/pneumonitis (e.g., dyspnea, cough, fever). Immediately withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE (when applicable) in patients with suspected ILD/pneumonitis and permanently discontinue if ILD/pneumonitis is confirmed.

Venous Thromboembolic (VTE) Events with Concomitant Use with LAZCLUZE

RYBREVANT FASPRO and RYBREVANT in combination with LAZCLUZE can cause serious and fatal venous thromboembolic (VTE) events, including deep vein thrombosis and pulmonary embolism. Without prophylactic anticoagulation, the majority of these events occurred during the first four months of treatment.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), all Grade VTE occurred in 11% of patients and 1.5% were Grade 3. 80% (n=164) of patients received prophylactic anticoagulation at study entry, with an all Grade VTE incidence of 7%. In patients who did not receive prophylactic anticoagulation (n=42), all Grade VTE occurred in 17% of patients. In total, 0.5% of patients had VTE leading to dose reductions of RYBREVANT FASPRO and no patients required permanent discontinuation. The median time to onset of VTEs was 95 days (range: 17 to 390).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), VTEs occurred in 36% of patients including Grade 3 in 10% and Grade 4 in 0.5% of patients. On-study VTEs occurred in 1.2% of patients (n=5) while receiving anticoagulation therapy. There were two fatal cases of VTE (0.5%), 9% of patients had VTE leading to dose interruptions of RYBREVANT, and 7% of patients had VTE leading to dose interruptions of LAZCLUZE; 1% of patients had VTE leading to dose reductions of RYBREVANT, and 0.5% of patients had VTE leading to dose reductions of LAZCLUZE; 3.1% of patients had VTE leading to permanent discontinuation of RYBREVANT, and 1.9% of patients had VTE leading to permanent discontinuation of LAZCLUZE. The median time to onset of VTEs was 84 days (range: 6 to 777).

Administer prophylactic anticoagulation for the first four months of treatment. The use of Vitamin K antagonists is not recommended.

Monitor for signs and symptoms of VTE events and treat as medically appropriate. Withhold RYBREVANT FASPRO or RYBREVANT and LAZCLUZE based on severity. Once anticoagulant treatment has been initiated, resume RYBREVANT FASPRO or RYBREVANT and LAZCLUZE at the same dose level at the discretion of the healthcare provider. In the event of VTE recurrence despite therapeutic anticoagulation, permanently discontinue RYBREVANT FASPRO or RYBREVANT. Treatment can continue with LAZCLUZE at the same dose level at the discretion of the healthcare provider. Refer to the LAZCLUZE Prescribing Information for recommended LAZCLUZE dosage modification.

Dermatologic Adverse Reactions

RYBREVANT FASPRO and RYBREVANT can cause severe rash including toxic epidermal necrolysis (TEN), dermatitis acneiform, pruritus and dry skin.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, rash occurred in 80% of patients, including Grade 3 in 17% and Grade 4 in 0.5% of patients. Rash leading to dose reduction occurred in 11% of patients, and RYBREVANT FASPRO was permanently discontinued due to rash in 1.5% of patients.

RYBREVANT with LAZCLUZE

In MARIPOSA, rash occurred in 86% of patients, including Grade 3 in 26% of patients. The median time to onset of rash was 14 days (range: 1 to 556 days). Rash leading to dose interruptions occurred in 37% of patients for RYBREVANT and 30% for LAZCLUZE, rash leading to dose reductions occurred in 23% of patients for RYBREVANT and 19% for LAZCLUZE, and rash leading to permanent discontinuation occurred in 5% of patients for RYBREVANT and 1.7% for LAZCLUZE.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, rash occurred in 82% of patients, including Grade 3 (15%) adverse reactions. Rash leading to dose reductions occurred in 14% of patients, and 2.5% permanently discontinued RYBREVANT and 3.1% discontinued pemetrexed.

RYBREVANT as a Single Agent

In CHRYSALIS, rash occurred in 74% of patients, including Grade 3 in 3.3% of patients. The median time to onset of rash was 14 days (range: 1 to 276 days). Rash leading to dose reduction occurred in 5% and permanent discontinuation due to rash occurred in 0.7% of patients. Toxic epidermal necrolysis occurred in one patient (0.3%).

When initiating treatment with RYBREVANT FASPRO or RYBREVANT and LAZCLUZE, prophylactic and concomitant medications are recommended to reduce the risk and severity of dermatologic adverse reactions. Instruct patients to limit sun exposure during and for 2 months after treatment. Advise patients to wear protective clothing and use broad spectrum UVA/UVB sunscreen.

If skin reactions develop, administer supportive care including topical corticosteroids and topical and/or oral antibiotics. For Grade 3 reactions, add oral steroids and consider dermatologic consultation. Promptly refer patients presenting with severe rash, atypical appearance or distribution, or lack of improvement within 2 weeks to a dermatologist. For patients receiving RYBREVANT FASPRO or RYBREVANT in combination with LAZCLUZE, withhold, reduce the dose, or permanently discontinue both drugs based on severity. For patients receiving RYBREVANT FASPRO or RYBREVANT as a single agent or in combination with carboplatin and pemetrexed, withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT based on severity

Hepatotoxicity

LAZCLUZE in combination with amivantamab can cause severe hepatotoxicity (including increased ALT and AST).

RYBREVANT with LAZCLUZE

In MARIPOSA, based on adverse reaction data, hepatotoxicity occurred in 49% of patients treated with LAZCLUZE, including Grade 3 in 9.3% of patients and Grade 4 in 0.5%. LAZCLUZE was interrupted for an adverse reaction of hepatotoxicity in 8% of patients, the dose was reduced in 1.4% and permanently discontinued in 0.2%.

Perform liver function tests (including ALT, AST, and total bilirubin) before initiation of LAZCLUZE and during treatment, as clinically indicated. Withhold, reduce the dose, or permanently discontinue LAZCLUZE and amivantamab based on severity.

Ocular Toxicity

RYBREVANT FASPRO and RYBREVANT can cause ocular toxicity including keratitis, blepharitis, dry eye symptoms, conjunctival redness, blurred vision, visual impairment, ocular itching, eye pruritus and uveitis.

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3, all Grade ocular toxicity occurred in 13% of patients, including 0.5% Grade 3.

RYBREVANT with LAZCLUZE

In MARIPOSA, ocular toxicity occurred in 16%, including Grade 3 or 4 ocular toxicity in 0.7% of patients.

RYBREVANT with Carboplatin and Pemetrexed

Based on the pooled safety population, ocular toxicity occurred in 16% of patients. All events were Grade 1 or 2.

RYBREVANT as a Single Agent

In CHRYSALIS, keratitis occurred in 0.7% and uveitis occurred in 0.3% of patients. All events were Grade 1-2.

Promptly refer patients presenting with new or worsening eye symptoms to an ophthalmologist. Withhold, dose reduce or permanently discontinue RYBREVANT FASPRO or RYBREVANT and continue LAZCLUZE based on severity.

Embryo-Fetal Toxicity

Based on animal models, RYBREVANT FASPRO, RYBREVANT and LAZCLUZE can cause fetal harm when administered to a pregnant woman. Verify pregnancy status of females of reproductive potential prior to initiating RYBREVANT FASPRO and RYBREVANT. Advise pregnant women and females of reproductive potential of the potential risk to the fetus. Advise patients of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of RYBREVANT FASPRO or RYBREVANT, and for 3 weeks after the last dose of LAZCLUZE.

ADVERSE REACTIONS

RYBREVANT FASPRO with LAZCLUZE

In PALOMA-3 (n=206), the most common adverse reactions (≥20%) were rash (80%), nail toxicity (58%), musculoskeletal pain (50%), fatigue (37%), stomatitis (36%), edema (34%), nausea (30%), diarrhea (22%), vomiting (22%), constipation (22%), decreased appetite (22%), and headache (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased lymphocyte count (6%), decreased sodium (5%), decreased potassium (5%), decreased albumin (4.9%), increased alanine aminotransferase (3.4%), decreased platelet count (2.4%), increased aspartate aminotransferase (2%), increased gammaglutamyl transferase (2%), and decreased hemoglobin (2%).

Serious adverse reactions occurred in 33% of patients, with those occurring in ≥2% of patients including ILD/pneumonitis (6%); and pneumonia, VTE and fatigue (2.4% each). Death due to adverse reactions occurred in 5% of patients treated with RYBREVANT FASPRO, including ILD/pneumonitis (1.9%), pneumonia (1.5%), and respiratory failure and sudden death (1% each).

RYBREVANT with LAZCLUZE

In MARIPOSA (n=421), the most common adverse reactions (ARs) (≥20%) were rash (86%), nail toxicity (71%), infusion-related reactions (IRRs) (RYBREVANT) (63%), musculoskeletal pain (47%), stomatitis (43%), edema (43%), VTE (36%), paresthesia (35%), fatigue (32%), diarrhea (31%), constipation (29%), COVID-19 (26%), hemorrhage (25%), dry skin (25%), decreased appetite (24%), pruritus (24%), and nausea (21%). The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased albumin (8%), decreased sodium (7%), increased ALT (7%), decreased potassium (5%), decreased hemoglobin (3.8%), increased AST (3.8%), increased GGT (2.6%), and increased magnesium (2.6%).

Serious ARs occurred in 49% of patients, with those occurring in ≥2% of patients including VTE (11%), pneumonia (4%), ILD/pneumonitis and rash (2.9% each), COVID-19 (2.4%), and pleural effusion and IRRs (RYBREVANT) (2.1% each). Fatal ARs occurred in 7% of patients due to death not otherwise specified (1.2%); sepsis and respiratory failure (1% each); pneumonia, myocardial infarction, and sudden death (0.7% each); cerebral infarction, pulmonary embolism (PE), and COVID-19 infection (0.5% each); and ILD/pneumonitis, acute respiratory distress syndrome (ARDS), and cardiopulmonary arrest (0.2% each).

RYBREVANT with Carboplatin and Pemetrexed

In MARIPOSA-2 (n=130), the most common ARs (≥20%) were rash (72%), IRRs (59%), fatigue (51%), nail toxicity (45%), nausea (45%), constipation (39%), edema (36%), stomatitis (35%), decreased appetite (31%), musculoskeletal pain (30%), vomiting (25%), and COVID-19 (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased neutrophils (49%), decreased white blood cells (42%), decreased lymphocytes (28%), decreased platelets (17%), decreased hemoglobin (12%), decreased potassium (11%), decreased sodium (11%), increased alanine aminotransferase (3.9%), decreased albumin (3.8%), and increased gamma-glutamyl transferase (3.1%).

In MARIPOSA-2, serious ARs occurred in 32% of patients, with those occurring in >2% of patients including dyspnea (3.1%), thrombocytopenia (3.1%), sepsis (2.3%), and PE (2.3%). Fatal ARs occurred in 2.3% of patients; these included respiratory failure, sepsis, and ventricular fibrillation (0.8% each).

In PAPILLON (n=151), the most common ARs (≥20%) were rash (90%), nail toxicity (62%), stomatitis (43%), IRRs (42%), fatigue (42%), edema (40%), constipation (40%), decreased appetite (36%), nausea (36%), COVID-19 (24%), diarrhea (21%), and vomiting (21%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased albumin (7%), increased alanine aminotransferase (4%), increased gamma-glutamyl transferase (4%), decreased sodium (7%), decreased potassium (11%), decreased magnesium (2%), and decreases in white blood cells (17%), hemoglobin (11%), neutrophils (36%), platelets (10%), and lymphocytes (11%).

In PAPILLON, serious ARs occurred in 37% of patients, with those occurring in ≥2% of patients including rash, pneumonia, ILD, PE, vomiting, and COVID-19. Fatal adverse reactions occurred in 7 patients (4.6%) due to pneumonia, cerebrovascular accident, cardio-respiratory arrest, COVID-19, sepsis, and death not otherwise specified.

RYBREVANT as a Single Agent

In CHRYSALIS (n=129), the most common ARs (≥20%) were rash (84%), IRR (64%), paronychia (50%), musculoskeletal pain (47%), dyspnea (37%), nausea (36%), fatigue (33%), edema (27%), stomatitis (26%), cough (25%), constipation (23%), and vomiting (22%). The most common Grade 3 to 4 laboratory abnormalities (≥2%) were decreased lymphocytes (8%), decreased albumin (8%), decreased phosphate (8%), decreased potassium (6%), increased alkaline phosphatase (4.8%), increased glucose (4%), increased gamma-glutamyl transferase (4%), and decreased sodium (4%).

Serious ARs occurred in 30% of patients, with those occurring in ≥2% of patients including PE, pneumonitis/ILD, dyspnea, musculoskeletal pain, pneumonia, and muscular weakness. Fatal adverse reactions occurred in 2 patients (1.5%) due to pneumonia and 1 patient (0.8%) due to sudden death.

LAZCLUZE DRUG INTERACTIONS

Avoid concomitant use of LAZCLUZE with strong and moderate CYP3A4 inducers. Consider an alternate concomitant medication with no potential to induce CYP3A4.

Monitor for adverse reactions associated with a CYP3A4 or BCRP substrate where minimal concentration changes may lead to serious adverse reactions, as recommended in the approved product labeling for the CYP3A4 or BCRP substrate.

(Press release, Johnson & Johnson, MAY 29, 2026, View Source [SID1234666222])

On May 29, 2026 Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, reported new overall survival data from its pivotal Phase 3 ROSELLA trial of Lifyorli (relacorilant) plus nab-paclitaxel (a taxane chemotherapy) in an oral presentation at the ASCO (Free ASCO Whitepaper) 2026 (American Society of Clinical Oncology) Annual Meeting.

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In ROSELLA, patients treated with Lifyorli combined with nab-paclitaxel experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio (HR): 0.65; p-value: 0.0004), with a median overall survival of 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone. No biomarker testing was required.

Patients in all of ROSELLA’s prespecified subgroups experienced meaningful survival benefits. The data presented at ASCO (Free ASCO Whitepaper) 2026 describe the overall survival benefit in patients whose treatment included a taxane-free interval of 6 months or less (HR: 0.60) and in those who received a taxane in their most recent treatment regimen (HR: 0.67).

"Relacorilant stands to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer, because of the consistent overall survival observed across all patient subgroups, including those with poor prognostic features and regardless of prior taxane exposure, without the need for biomarker selection," said Lucy Gilbert, M.D., Director of Gynecologic Oncology at McGill University Health Centre, Chair of Oncology, McGill University, Montreal.

"The results of the ROSELLA study clearly demonstrate that antagonizing the effects of cortisol at the glucocorticoid receptor (GR) can deliver improved survival outcomes in patients with a challenging-to-treat cancer," said Bill Guyer, PharmD, Corcept’s Chief Development Officer. "They support our long-standing belief in the potential of our GR antagonists to treat patients with many tumor types. We are working to advance GR research in many different treatment settings, including platinum-sensitive ovarian, endometrial, cervical, pancreatic and prostate cancers."

Lifyorli, in combination with nab-paclitaxel, was approved by the U.S. Food and Drug Administration (FDA) in March 2026 for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist. It is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer.

In ROSELLA, the combination of Lifyorli with nab-paclitaxel was well-tolerated. Adverse events were comparable to those in the nab-paclitaxel monotherapy arm. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. The ROSELLA trial was conducted in collaboration with The GOG Foundation, Inc. (GOG-F) (GOG-3073), the European Network of Gynaecological Oncological Trial groups (ENGOT) (ENGOT-ov72), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT) (APGOT-Ov10), the Latin American Cooperative Oncology Group (LACOG) (LACOG-0223) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG) (ANZGOG-221/2023).

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.

About Cortisol’s Role in Oncology

Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.

Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.

About Lifyorli

Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.

It is included in the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a preferred regimen for patients with platinum-resistant ovarian cancer.

Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support at 1-85-LIFYORLI (1-855-439-6754).

LIFYORLI Indication & Usage

LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab.

IMPORTANT SAFETY INFORMATION

Contraindications:

LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids.

Warnings and Precautions:

Neutropenia and Severe Infections
LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy.

Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection.

Adrenal Insufficiency
LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity.

Exacerbation of Conditions Treated with Glucocorticoids
Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both.

Embryo-Fetal Toxicity
LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose.

Adverse Reactions:

Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%).

Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued.

The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite.

Drug Interactions:

Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness.
CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness.
CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions.
CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates.
Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates.
Use in Specific Populations:

Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose.
Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients.
Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST).

(Press release, Corcept Therapeutics, MAY 29, 2026, https://ir.corcept.com/news-releases/news-release-details/corcept-presents-new-data-asco-2026-lifyorlitm-overall-survival [SID1234666194])

On May 29, 2026 XtalPi (2228.HK), an AI- and robotics- powered drug discovery platform, reported that its strategic collaboration with innovative biopharmaceutical company DoveTree Medicines Unus Inc. has achieved substantial progress, and that XtalPi has received the second payment under the agreement.

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Since the two parties entered into a collaboration in June 2025 with a total possible aggregate value of up to US $5.99 billion if resulting in an approved product directed to each of the targets of interest to DoveTree, the partnership has made significant progress. All patents related to the pipeline from the initial upfront payment of US$51 million have now been fully transferred to DoveTree. One preclinical candidate (PCC) has advanced into IND-enabling studies. According to the agreement, XtalPi has now received the second payment of US$19 million. The two parties will further deepen discovery collaboration with agreed priorities and continuously accelerate translation from discovery to clinical development.

XtalPi’s proprietary dynamic conformation precision modeling platform uses quantum physics algorithms and AI-driven multiscale molecular simulations as dual engines. Rather than relying on static crystal structures, it simulates more complete processes of a target protein’s conformational dynamics in a physiologically relevant environment at atomic-level precision. This allows the platform to accurately capture transiently exposed allosteric sites and PPI interfaces that traditional methods often miss, providing high-resolution structural insights that guide molecular design with both speed and accuracy.

Meanwhile, XtalPi’s integrated drug discovery platform—combining AI, physics-based design, and automation-driven synthesis and optimization—seamlessly connects molecular virtual screening with physical synthesis, accelerating the feedback loop between design and validation. Based on structural information generated by the dynamic conformation model, XtalPi has established predictive models for protein complexes used in hit compound screening, enabling highly efficient virtual screening. High-potential molecules with superior drug-like properties are then evaluated for synthesizability and synthetic routes by the company’s proprietary SureRXN reaction prediction model, after which a fleet of automated robotic workstations conduct parallel synthesis and activity testing, forming a high-throughput closed-loop iteration of "Design–Make–Test–Analyze" (DMTA).

This system can synthesize and test 3,000–4,000 novel molecules within 2–3 months, with a synthesis success rate consistently above 80%. Even when facing entirely new targets with extremely limited prior data, the platform can rapidly accumulate high-quality empirical data within a very short timeframe, continuously driving algorithm optimization and molecular evolution. This end-to-end capability — from mechanistic insight to physical delivery — brings historically intractable targets onto a significantly de-risked preclinical development trajectory, with the potential to accelerate their transformation into clinically actionable assets.

The momentum of the XtalPi–DoveTree collaboration programs is built on the strengths of both partners: DoveTree brings deep expertise in target biology, translational medicine, and modality innovation, while XtalPi is redefining the efficiency and scalability of molecular discovery through AI and automation.

The combined strengths of the two companies not only enable new drug discovery programs to advance rapidly from initiation to the clinic, but also ensure that these programs address high unmet medical needs by tackling highly validated, difficult-to-drug targets with clear paths to clinical translation and commercialization.

XtalPi is eligible to receive future milestones and royalties, allowing the long-term value of its AI platform to be realized through pipeline expansion and advancement.

Dr. Gregory Verdine, Founder and CEO of DoveTree, stated:

"XtalPi has built an impressive platform operating at the convergence of AI, physics-based molecular design, and automation-driven synthesis and optimization. These integrated capabilities have the potential to improve both the speed and quality of discovery efforts against challenging biological targets. We are pleased with the progress of the collaboration to date and look forward to advancing additional programs toward clinical development."

Dr. Wen Shuhao, Chairman of XtalPi, stated:

"Our collaboration with DoveTree continues to generate verifiable results. This not only validates the advantages of our technological pathway, but also gives us strong conviction as we scale the pipeline. XtalPi has already established a complete closed loop from target discovery to PCC across multiple real-world R&D projects. Our focus now is on systematically extending this approach to a broader set of high-value targets, delivering innovation with a higher probability of success for the industry, and pushing the boundaries of what can be achieved in drug discovery."

(Press release, XtalPi, MAY 29, 2026, View Source [SID1234666224])

On May 29, 2026, Lisata Therapeutics, Inc. (the "Company" or "Lisata") and Kuva Labs Inc., a Delaware corporation ("Parent"), together with Kuva Acquisition Corp., a Delaware corporation and a wholly owned subsidiary of Parent ("Purchaser"), reported to have entered into an amendment (the "Amendment") to the previously announced Agreement and Plan of Merger, dated as of March 6, 2026, by and among Parent, Purchaser and the Company (the "Original Merger Agreement" and, as it may be amended from time to time, the "Merger Agreement"). Pursuant to the Amendment, the Company, Parent and Purchaser agreed to amend the offer price per share of common stock, par value $0.001 per share (the "Common Shares"), of the Company under the Original Merger Agreement from (A) (i) $5.00 per Common Share, net to the seller in cash, without interest, but subject to any applicable withholding of taxes plus (ii) one (1) non-tradeable contingent value right (each, a "CVR") which represents the contractual right to receive a contingent cash payment of $1.00 per CVR, subject to achievement of a specified milestone, to (B) (i) $4.00 per Common Share, net to the seller in cash, without interest, but subject to any applicable withholding of taxes plus (ii) one non-tradeable contingent value right which represents the contractual right to receive two contingent cash payments of up to an aggregate of $3.00 per CVR, subject to achievement of specified milestones.

Pursuant to the Amendment, the form of contingent value rights agreement attached to the Original Merger Agreement was amended and restated in its entirety as set forth in the form of contingent rights agreement attached to the Amendment as Exhibit A thereto (the "CVR Agreement"). Under the CVR Agreement, each CVR represents a non-tradable contractual contingent right to receive one (1) contingent cash payment of $1.25 per CVR (the "First Milestone Payment") upon the achievement of, with respect to a Phase 2a, double-blind, placebo-controlled, randomized, proof-of-concept study evaluating LSTA1 when added to standard of care (temozolomide) versus temozolomide and matching LSTA1 placebo in subjects with newly diagnosed Glioblastoma Multiforme (GBM) (Protocol Number: LSTA1-GBM-2A), (i) completion of enrollment of such trial, (ii) the enrollment of at least 90% of the target number of subjects of such trial or (iii) the termination of such trial by its sponsor for any reason (with the term "enrollment" meaning the process of registering qualified participants into such trial after confirming eligibility and obtaining informed consent, marking the point at which the participant becomes a subject of such trial) (the "First Milestone"), which shall be due and payable on the later of December 15, 2026 and the date that is forty-five (45) days following the achievement of the First Milestone, and one (1) contingent cash payment of $1.75 per CVR (the "Second Milestone Payment" and, collectively with the First Milestone Payment, the "Milestone Payments") upon the achievement of the filing or formal acceptance for review by any Governmental Body (as defined in the Merger Agreement) of any (i) New Drug Application submitted to the FDA in the U.S. in accordance with the FDCA requesting approval to market or commercialize any pharmaceutical product that contains or incorporates the product candidate referred to as certepetide (formerly LSTA1 or CEND-1), alone or in combination with one or more other therapeutically active ingredients, including all formulations, dosages, or modes of delivery thereof (the "CVR Product") for any indication or patient population, or (ii) analogous application or submission to any other applicable Governmental Body requesting approval to market or commercialize the CVR Product for any indication or patient population (the "Second Milestone" and, collectively with the First Milestone, the "Milestones"), which shall be due and payable on the date that is forty-five (45) days following the achievement of the Second Milestone, in each case, prior to the earliest of (a) the mailing by the Rights Agent to the address or the payment of the Rights Agent to each holder of the Milestone Payment, (b) 11:59 p.m. New York City Time on the seventh (7th) anniversary of the Closing Date (as defined below), and (c) termination of the CVR Agreement. The CVR Agreement provides that, in the event that Parent fails to pay the First Milestone Payment in full on or prior to the date that it is due and payable, all unpaid amounts shall accrue interest commencing on such date, at a rate equal to the least of (x) ten percent (10%) per annum, (y) the Secured Overnight Financing Rate as published by the Federal Reserve Bank of New York (or any successor administrator thereof) as of such date, plus five percent (5%) per annum, and (z) the maximum rate permitted under applicable Law, in each case calculated on the basis of a 365-day year and the actual number of days elapsed, until all such amounts are paid in full.

In addition, pursuant to the Amendment, the Company, Parent and Purchaser agreed that, upon commencement of the tender offer for all of the outstanding shares of common stock of the Company (the "Offer") on June 1, 2026, the date by which Purchaser is obligated under the Merger Agreement to commence the Offer would automatically be extended from May 29, 2026 to June 1, 2026, or such other date as may be agreed to between the Company and Parent. The Amendment also extended the Outside Date (as defined in the Merger Agreement) from July 1, 2026 to July 6, 2026.

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(Filing, Lisata Therapeutics, MAY 29, 2026, View Source [SID1234666197])

On May 29, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the results from the multinational phase 3 WU-KONG28 study showing that ZEGFROVY (sunvozertinib) monotherapy demonstrated superior anti-tumor efficacy, compared to platinum-doublet chemotherapy, in untreated NSCLC patients with EGFR exon 20 insertion mutations (exon20ins). These data were presented as a Late-Breaking Abstract Oral Presentation (#LBA8500) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine (The NEJM).

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As of January 16, 2026, 324 patients were randomized in a 1:1 ratio to receive either ZEGFROVY or chemotherapy. ZEGFROVY, administered at 300 mg once daily, demonstrated statistically significant and clinically meaningful improvement in progression-free survival (PFS), the primary endpoint of the study, as assessed by blinded independent central review (BICR). The overall safety profile was consistent with previous studies, no new safety finding.

Median PFS was 10.3 months with ZEGFROVY versus 7.5 months with chemotherapy (HR=0.65; P=0.0008).
BICR-assessed best objective response rate (BoR) was 68.1% with ZEGFROVY versus 35.4% with chemotherapy, and median duration of response (DoR) was 11.2 months versus 7.1 months.
The overall safety profile was consistent with previous studies, with adverse reactions generally manageable and reversible.
"Over the past two decades, treatment for EGFR-mutated NSCLC has evolved substantially, with targeted therapies transforming outcomes. However, patients with EGFR exon20ins NSCLC have continued to face limited treatment options, particularly in the first-line setting," said John Heymach, M.D., Ph.D, Chair of Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center, and presenting author. "The WU-KONG28 trial marks a clinical turning point. The data demonstrate that a single-agent targeted oral regimen can deliver superior antitumor efficacy over conventional chemotherapy, offering a practice-changing alternative that may spare treatment-naïve patients from initial cytotoxic treatment."

"The current first-line management of EGFR exon20ins NSCLC remains chemotherapy-bound, highlighting a substantial unmet need for a precision targeted therapy that simultaneously balances robust efficacy, favorable safety, and oral administration convenience," said Caicun Zhou, M.D., Ph.D, Shanghai East Hospital affiliated with Tongji University, Lead Principal Investigator of WU-KONG28, and corresponding author of The NEJM article. "The WU-KONG28 study demonstrates that ZEGFROVY monotherapy yields superior antitumor efficacy compared to platinum-doublet chemotherapy, while maintaining a manageable safety profile and enhanced convenience. These findings support the potential to usher the first-line treatment of EGFR exon20ins NSCLC into a chemotherapy-free era, providing global patients a more precise single-agent targeted therapeutic option."

"The presentation of WU-KONG28 as an ASCO (Free ASCO Whitepaper) Late-Breaking Abstract (LBA) and its simultaneous publication in The NEJM underscore the clinical significance and quality of the study," said Dr. Xiaolin Zhang, CEO of Dizal. "WU-KONG28 study demonstrates that ZEGFROVY can provide superior benefits for treatment naïve patients. It is the first positive study for this difficult disease, providing a chemotherapy-free option for patients globally. It is the first global phase 3 study conducted by Dizal. I am deeply grateful to our patients, their families, and investigators of the study. I am very proud of our team for this fantastic achievement."

ZEGFROVY has previously been granted accelerated approvals in both the U.S. and China for the treatment of relapsed or refractory EGFR exon20ins NSCLC. Based on the positive results of WU-KONG28, the New Drug Application (NDA) for ZEGFROVY as a first-line treatment for EGFR exon20ins NSCLC has been accepted and granted Priority Review designation by China’s National Medical Products Administration (NMPA).

About ZEGFROVY(sunvozertinib)

ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.

In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.

ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.

Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals including Cancer Discovery, The Lancet Respiratory Medicine, Journal of Clinical Oncology, and The New England Journal of Medicine.

About WU-KONG28

WU-KONG28 is a multinational, open-label, randomized confirmatory phase 3 study evaluating ZEGFROVY versus platinum-based chemotherapy as first-line treatment in advanced NSCLC patients with EGFR exon20ins. The study enrolled patients across 15 countries and regions in Asia, Europe, North America and South America. The primary endpoint is progression-free survival (PFS) assessed by BICR.

(Press release, Dizal Pharma, MAY 29, 2026, View Source [SID1234666226])