On June 12, 2026 AstraZeneca reported that Truqap (capivasertib) in combination with abiraterone and prednisone has been approved in the US as the first and only targeted treatment for adult patients with PTEN-deficient metastatic androgen pathway modulation-naïve or sensitive (mAPMN/S) prostate cancer, previously referred to as metastatic hormone-sensitive prostate cancer (mHSPC), as detected by a US Food and Drug Administration (FDA)-authorised test.1

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The approval by the US FDA was based on positive results from the CAPItello-281 Phase III trial, presented at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and published in Annals of Oncology.2

Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with more than 1.4 million people diagnosed each year.3 Of these, approximately 200,000 patients worldwide, including 35,000 in the US, are diagnosed with mAPMN/S prostate cancer annually.4 One in four of these patients have PTEN-deficient tumours, which fuels the growth of cancer cells and defines an aggressive form of the disease associated with poor outcomes.4-7 PTEN deficiency is an independent risk factor regardless of other clinical characteristics, and can be identified by immunohistochemistry testing at time of diagnosis.7

Daniel George, MD, Director of Genitourinary Oncology at Duke Cancer Institute and investigator for the CAPItello-281 trial, said: "Patients with PTEN-deficient metastatic hormone-sensitive prostate cancer, now called metastatic androgen pathway modulation-naïve or sensitive prostate cancer, experience faster progression and worse prognosis than those without PTEN deficiency. Keeping patients with this form of prostate cancer in remission and free from disease progression as long as possible is a high priority. Today’s landmark approval of the capivasertib combination as the first and only targeted treatment option for these patients represents a significant clinical advance with the potential to improve their lives and change the course of disease."

Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: "CAPItello-281 showed that for the first time, we can target a key driver of this disease to bring meaningful benefit to the one in four patients with this form of prostate cancer who urgently need biomarker-directed therapies. Today’s approval makes clear the importance of testing for actionable biomarkers, including PTEN deficiency, in prostate cancer."

Results from the primary analysis of the CAPItello-281 Phase III trial showed a statistically significant 19% reduction in the risk of radiographic disease progression or death and a clinically meaningful improvement in median radiographic progression-free survival (rPFS) of 7.5 months with Truqap in combination with abiraterone and androgen deprivation therapy (ADT) versus treatment with abiraterone and ADT with placebo (based on a hazard ratio [HR] of 0.81; 95% confidence interval [CI] 0.66–0.98; p=0.034). Median rPFS was 33.2 months for the Truqap combination versus 25.7 months for the comparator arm.2 While overall survival (OS) data were immature at the time of the primary analysis, results for OS numerically favoured the Truqap combination versus the comparator arm. The trial will continue as planned to further assess OS as a key secondary endpoint.

The safety profile of Truqap in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine. Grade 3 or higher adverse events occurred in 67% of patients treated with the Truqap combination, with rash (12.3%) and hyperglycaemia (10.3%) the most frequently reported.2

Concurrently with this approval, the FDA also approved a companion diagnostic test to detect PTEN deficiency in tumours of patients with prostate adenocarcinoma.

A regulatory application for the Truqap combination in this setting is under review in the EU based on the CAPItello-281 Phase III trial.

Notes

Prostate cancer
In the US, prostate cancer is the most common cancer in men, with more than 300,000 new cases of the disease diagnosed annually, and more than 36,000 deaths.8

Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.9 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.10

Metastatic androgen pathway modulation-naïve or sensitive prostate cancer
mAPMN/S prostate cancer, previously referred to as mHSPC or metastatic castration-sensitive prostate cancer (mCSPC) reflects new, redefined terminology for clinical trials and regulatory indications in prostate cancer.1 In patients with mAPMN/S prostate cancer, prostate cancer cells need high levels of androgens to drive cancer growth.5,10 Hormone therapies, such as androgen deprivation therapies, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.5,10 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.5,6,11

mAPMN/S prostate cancer is an aggressive form of the disease associated with poor outcomes and survival.5,6 Globally, approximately 200,000 patients are diagnosed with mAPMN/S prostate cancer each year, with 35,000 patients diagnosed with the disease in the US.4 One in four of these patients have PTEN-deficient tumours.4

PTEN-loss or deficiency fuels the growth of cancer cells, leading to dysregulation of the PI3K/AKT pathway, and is associated with poor outcomes in patients with prostate cancer.12,13

CAPItello-281
CAPItello-281 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with newly diagnosed PTEN-deficient mAPMN/S prostate cancer.

The global trial enrolled 1,012 adult patients with histologically confirmed newly diagnosed APMN/S prostate adenocarcinoma and PTEN deficiency as confirmed by central testing. The primary endpoint of the CAPItello-281 trial is rPFS as assessed by investigator, with OS as a key secondary endpoint.

Truqap
Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.

Truqap in combination with Faslodex (fulvestrant) is approved in the US, EU, Japan, China and a number of other countries for the treatment of adult patients with HR-positive (or estrogen receptor-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.

Truqap is currently being evaluated in combination with established treatments for the 1st-line treatment of HR-positive breast cancer in the Phase III CAPItello-292 trial.

Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).

(Press release, AstraZeneca, JUN 12, 2026, View Source [SID1234666605])

On June 12, 2026 PharmaMar (MSE: PHM), reported top-line results from its Phase III LAGOON trial evaluating Zepzelca (lurbinectedin) in patients with relapsed (second line) metastatic small cell lung cancer (SCLC), which did not meet its primary endpoint of Overall Survival (OS) compared with control arm, nor did the exploratory combination with irinotecan. Safety for lurbinectedin monotherapy is better compared to the control group.

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The LAGOON study targeted a different population in a different setting of SCLC than the IMforte Phase III trial first line maintenance with atezolizumab (Tecentriq) and does not impact lurbinectedin approval in the first-line maintenance setting.

The full European Commission (EC) and U.S. approval of lurbinectedin is based on the Phase III IMforte trial, which evaluated lurbinectedin in combination with atezolizumab as first-line maintenance treatment for patients with extensive-stage SCLC. In the IMforte trial, the lurbinectedin 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 lurbinectedin 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.

PharmaMar and its partners will share the results with regulatory bodies as needed at appropriate time.

Key Results from the Phase III LAGOON Trial

The LAGOON trial included a broader patient population than the Phase 2 pivotal trial that supported the second-line approval, including patients with a history of CNS involvement.

The outcome of this trial may be impacted by the unexpected OS outperformance of the control arm by 30% (topotecan mOS 10.8) when compared to most recent phase III trials (topotecan 8.3m,)[1] in this setting.

Trial Population Lurbinectedin monotherapy Median OS Lurbinectedin+ irinotecan Median OS Control Median OS HR (95% CI)
Lurbinectedin vs Control HR (95% CI)
Lurbinectedin+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 lurbinectedin was favorable relative to the control arm. Treatment-related adverse events (TRAE) were 78.5% with lurbinectedin, 95% with lurbinectedin + irinotecan, and 93.8% with the control arm. TRAEs Grade ≥ 3 were 35% with lurbinectedin, 62.6% with lurbinectedin + irinotecan, and 64.4% with the control arm.

We expect to submit the results to a medical meeting for presentation.

PharmaMar would like to thank all the patients, their families, and the medical staff involved in the study.

(Press release, PharmaMar, JUN 12, 2026, View Source [SID1234666603])

On June 12, 2026 HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) reported results from the Phase III part of the ESLIM-02 study of sovleplenib in patients with warm antibody autoimmune hemolytic anemia ("wAIHA") in China were presented on Thursday, June 11, 2026 during the European Hematology Association (EHA) (Free EHA Whitepaper) ("EHA") Congress in Stockholm, Sweden.

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Supported by data from the ESLIM-02 study, a New Drug Application ("NDA") for sovleplenib for the treatment of adult patients with wAIHA who have had an insufficient response to at least one previous glucocorticoid treatment has been accepted for review and granted priority review by the China National Medical Products Administration ("NMPA") in April 2026. The NMPA granted Breakthrough Therapy Designation to sovleplenib for the treatment of wAIHA in March 2026. The ESLIM-02 presentation was selected for the official EHA (Free EHA Whitepaper) Press Program.

Professor Bing Han of Peking Union Medical College Hospital, and co-leading Principal Investigator of the ESLIM-02 study, said: "The wAIHA treatment paradigm has remained stagnant for decades, with patients often trapped in a cycle of high-dose steroids and frequent relapses. The ESLIM-02 data are transformative as they demonstrate that targeting the Syk pathway can achieve both rapid and durable control of hemolysis. We are particularly encouraged by the robust data across all patient subgroups, regardless of their prior treatments. Sovleplenib’s ability to significantly reduce the need for rescue therapies and blood transfusions represents a major step forward in restoring the quality of life for these patients."

ESLIM-02 is a randomized, double blind, placebo-controlled China Phase II/III study in adult patients with primary or secondary wAIHA who had relapsed or were refractory to at least one prior line of standard treatment (NCT05535933). Results from the Phase II part of the study were published in The Lancet Haematology in January 2025. In Phase III part of the study, 90 patients were randomized 1:1 to receive either sovleplenib (n=44) or placebo (n=46) at a dose of 300 mg once daily for 24 weeks.

The study met its primary endpoint, with sovleplenib demonstrating a significantly higher durable response rate during weeks 5–24 compared to placebo (66% vs 15%, p<0.0001). During the 24-week double-blind treatment period, sovleplenib demonstrated superior efficacy across several key metrics; specifically, the overall response rate—defined as hemoglobin (Hb) ≥100 g/L with an increase of ≥20 g/L from baseline without rescue therapy—was significantly increased (70% vs 22%, p<0.0001). The use of protocol-defined rescue therapy was significantly reduced with sovleplenib (16% vs 54%, p=0.0001), fewer patients received red blood cell transfusion (11% vs 43%) and higher patients with tapering or discontinuation of glucocorticoids or other baseline concomitant anti-wAIHA therapies (50% vs 15%, p=0.003​).

Median time to response was 3.1 weeks for sovleplenib versus 6.3 weeks for placebo, while the median cumulative duration of response among overall responders was 16.1 versus 6.1 weeks, respectively. Additionally, an improvement in hemolytic markers was observed with sovleplenib compared with placebo, showing an alleviation of active hemolysis.

These efficacy findings remained consistent across all sensitivity analyses, and all subgroup analyses further supported the primary endpoint results. Notably, in patients who had received prior rituximab therapy, the durable response rate continued to favor sovleplenib over placebo (69% vs 16%, p=0.0022).

Sovleplenib demonstrated a favorable safety profile. Grade ≥3 treatment-emergent adverse events ("TEAE") were reported in 43% patients in the sovleplenib arm and 59% patients in the placebo arm. The most common Grade ≥3 TEAEs, occurring in at least 10% of patients, were warm autoimmune hemolytic anemia (18% vs 43%) and upper respiratory tract infection (2% vs 11%). There were no TEAE-related deaths or treatment discontinuations reported in the sovleplenib group.

Details of the presentation are as follows:

Title:

A randomized, double-blind, placebo-controlled Phase 3 study of ESLIM-02 for efficacy and safety of sovleplenib (HMPL-523) in patients with warm autoimmune hemolytic anemia in China

Lead Author:

Bing Han, Peking Union Medical College Hospital, Chinese Academy of Medical Science, Beijing, China

Session:

Oral Session (Targeted therapies in rare red cell and metabolic disorders)

Presentation ID:

S301

Date & Time:

Thursday, 11 June 2026, 17:00 CEST

Location:

A13 Hall

About Sovleplenib and wAIHA

Sovleplenib is a novel, investigational, selective small molecule inhibitor for oral administration targeting Syk. Syk is a major component in B-cell receptor and Fc receptor signaling and is an established target for the treatment of multiple subtypes of B-cell lymphomas and autoimmune disorders.

The accelerated clearance of antibody-coated RBCs by immunoglobulin Fc-gamma receptor (FcγR) bearing macrophages is thought to be the pathogenic mechanism in wAIHA.1 Activated Syk mediates downstream signaling of the activated Fc receptors in phagocytic cells, resulting in phagocytosis of RBCs.2 In addition, activation of Syk through the B-cell receptor mediates activation and differentiation of B-lymphocytes into antibody secreting plasma cells.3 Inhibition of Syk may have potential effects in the treatment of wAIHA through inhibition of phagocytosis and reduction of antibody production.

In addition to wAIHA, sovleplenib is also being studied in immune thrombocytopenia ("ITP"). Positive results from ESLIM-01 (NCT05029635), a Phase III trial in China of sovleplenib in patients with primary ITP, have been published in The Lancet Haematology. The NMPA accepted for review the resubmitted NDA filing for the treatment of ITP and granted it priority review in February 2026. According to IQVIA, China has 430,000 existing patients with 41,000 new ITP patients each year. About half of ITP patients fail to have satisfactory results from currently approved treatments such as TPO (thrombopoietin) / TPO-RAs (thrombopoietin receptor agonists).

HUTCHMED currently retains all rights to sovleplenib worldwide.

(Press release, Hutchison China MediTech, JUN 12, 2026, View Source [SID1234666602])

On June 11, 2026 Quetzal Therapeutics, a biopharmaceutical company focused on developing therapies for rare hematologic malignancies, reported that the first patient has been dosed in QUATRO-APL, the company’s global Phase 3 clinical trial evaluating QTX-2101, an investigational oral capsule formulation of arsenic trioxide, in combination with all-trans retinoic acid (ATRA), for the treatment of patients with newly diagnosed, low-risk Acute Promyelocytic Leukemia, or APL.

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"Dosing the first patient in QUATRO-APL is an important clinical development milestone for Quetzal," said Usman Ahmed, Chief Executive Officer and Chairman of Quetzal Therapeutics. "We look forward to continued enrollment and to working with our investigators, clinical sites, and partners as the trial progresses."

"Current standard-of-care regimens for APL require a significant number of intravenous infusions over the course of therapy, which can be burdensome for patients and healthcare systems," said Shaad Abedin, M.D., Chief Medical Officer of Quetzal Therapeutics. "QUATRO-APL is designed to evaluate whether an oral formulation of arsenic trioxide can offer a potential alternative to intravenous administration. We are grateful to the investigators, site teams, and partners whose commitment made this milestone possible."

Quetzal Therapeutics expects continued site activation and patient enrollment across the United States and Europe as the global Phase 3 program advances and plans to provide additional updates on study progress as enrollment continues.

About the QUATRO-APL Trial

QUATRO-APL (QTX-2101-301) is a pivotal, open-label Phase 3 clinical study evaluating the efficacy, safety, and pharmacokinetics of QTX-2101, an oral capsule formulation of arsenic trioxide, in combination with all-trans retinoic acid (ATRA), in adult patients with newly diagnosed, low-risk acute promyelocytic leukemia. The comparator arm is intravenous arsenic trioxide plus ATRA.

Additional information is available at ClinicalTrials.gov (NCT07504458) and the EU Clinical Trials Information System (2025-524810-28-00).

About Acute Promyelocytic Leukemia

APL is a rare and aggressive subtype of acute myeloid leukemia, accounting for approximately 10-15% of all AML cases. It is defined by the PML-RARA gene fusion and is associated with severe bleeding complications and rapid disease progression if untreated. While advances in therapy have transformed outcomes, current treatments often require patients to undergo a large number of lengthy intravenous infusions over the course of therapy. This relentless treatment schedule can disrupt daily life and place a significant burden on both patients and their support networks. There remains a clear need for innovative and more accessible therapies.

(Press release, Quetzal Therapeutics, JUN 11, 2026, View Source [SID1234666604])

On June 11, 2026 Parabilis Medicines, Inc. (Nasdaq: PBLS) ("Parabilis"), a clinical-stage biopharmaceutical company built to develop transformative medicines addressing some of the most consequential, yet historically undruggable, protein targets driving human disease, reported the closing of its upsized initial public offering of an aggregate 38,525,000 shares of its common stock, including the full exercise by the underwriters of their overallotment option to purchase 5,025,000 additional shares, at an initial public offering price of $20.00 per share. All of the shares of common stock were offered by Parabilis. Parabilis’ common stock began trading on the Nasdaq Global Select Market on June 10, 2026 under the ticker symbol "PBLS".

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Leerink Partners, BofA Securities, Evercore ISI and Guggenheim Securities acted as active book-running managers for the offering. LifeSci Capital acted as a passive bookrunning manager for the offering.

In addition to the shares sold in the initial public offering, Parabilis reported the closing on June 11, 2026, of its sale of 4,166,666 shares of common stock at $18.00 per share, or 90% of the initial public offering price per share, in a concurrent private placement to Regeneron Pharmaceuticals, Inc. The sale of the shares of common stock in the concurrent private placement was not registered under the Securities Act of 1933, as amended.

The gross proceeds to Parabilis from the initial public offering, including full exercise of the underwriters’ option to purchase additional shares, before deducting underwriting discounts and commissions, and offering expenses payable by Parabilis, were $770.5 million. In addition, Parabilis received proceeds of approximately $75 million from the sale of shares of common stock in the concurrent private placement. All of the shares of common stock were offered by Parabilis.

In connection with the initial public offering, all Parabilis preferred stock converted into common stock, and a $50 million Simple Agreement for Future Equity ("SAFE") held by Explore Investments LLC converted into common stock.

Parabilis has raised over $1.2 billion in funding (before fees and expenses) in 2026, across public and private financings and strategic collaborations, to support its mission to create extraordinary medicines for patients.

Registration statements relating to the initial public offering have been filed with the Securities and Exchange Commission (the "SEC") and became effective on June 9, 2026. The offering was made only by means of a prospectus forming part of the effective registration statement relating to these shares. Copies of the final prospectus may be obtained from the SEC’s website at www.sec.gov or from: Leerink Partners LLC, Attn: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, telephone: 1-800-808-7525, email: [email protected]; BofA Securities, Inc., Attn: Prospectus Department, 201 North Tryon Street, Charlotte, NC 28255-0001, email: [email protected]; Evercore Group L.L.C., Attn: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, telephone: (888) 474-0200, email: [email protected]; or Guggenheim Securities, LLC, Attn: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, New York 10017, telephone: (212) 518-9544, email: [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, 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 registration or qualification under the securities laws of any such state or jurisdiction.

(Press release, Parabilis Medicines, JUN 11, 2026, View Source [SID1234666601])