On September 13, 2026 Daiichi Sankyo reported positive results from the DESTINY-Lung04 phase 3 trial showed Enhertu (trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus global standard of care (platinum-pemetrexed doublet chemotherapy plus pembrolizumab) as a first-line treatment of patients with unresectable, locally advanced or metastatic HER2 mutant non-squamous non-small cell lung cancer (NSCLC). Results were presented today (#PL03.08) in Presidential Symposium 2 at the IASLC 2026 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC26).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Enhertu is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN).

In the primary endpoint analysis, Enhertu monotherapy significantly reduced the risk of disease progression or death by 37.0% versus pembrolizumab plus chemotherapy (hazard ratio [HR] = 0.63; 95% confidence interval [CI]: 0.50-0.79; p<0.0001). Median PFS was 14.3 months (95% CI: 12.4-16.5) with Enhertu compared to 8.3 months (95% CI: 7.0-9.9) for pembrolizumab plus chemotherapy as assessed by blinded independent central review (BICR). A favorable PFS trend was seen for Enhertu across key subgroups, including the prespecified stratification factors of presence or history of brain metastases, smoking status, HER2 mutation status (exon 19 or exon 20), de novo or recurrent disease and presence of liver metastases.

Objective response rate (ORR) with Enhertu was 70.0% (95% CI: 63.6-75.9) versus 44.5% (95% CI: 37.9-51.2) with pembrolizumab plus chemotherapy. Median duration of response (DOR) for Enhertu was 13.4 months (95% CI: 10.4-17.2) and 9.7 months (95% CI: 7.0-11.1) with pembrolizumab plus chemotherapy. Median PFS2 (time from treatment start to second tumor progression or death from any cause) with Enhertu was 22.7 months (95% CI: 20.3-26.3) compared to 17.3 months (95% CI: 15.6-21.8) with pembrolizumab plus chemotherapy.

At the time of analysis, the overall survival (OS) data were 46.9% mature and no formal hypothesis testing was performed. While there was no observed benefit in OS, varied and imbalanced subsequent therapy patterns between arms may limit the interpretation of this result. Imbalances include greater use of HER2 directed therapies in the pembrolizumab plus chemotherapy arm versus the Enhertu arm (48.0% versus 23.3%), and limited use of subsequent immunotherapy plus chemotherapy in the Enhertu arm (23.8%).

"HER2 mutant non-small cell lung cancer is an aggressive disease with limited responses to current first-line standard of care and many patients experience disease progression within a year of starting treatment," said Julia Rotow, MD, Assistant Professor of Medicine, Dana-Farber Cancer Institute and Lead Investigator of the DESTINY-Lung04 Trial. "With 70 percent of patients responding and a median progression-free survival of 14.3 months, trastuzumab deruxtecan has the potential to become an important new first-line treatment option for these patients."

The safety profile of Enhertu observed in DESTINY-Lung04 was generally consistent with its known profile with no new safety signals identified. Grade 3 or higher treatment related adverse events (TRAE) occurred in 34.1% of patients treated with Enhertu. The most common grade 3 or higher TRAE occurring in 5% or more of patients treated with Enhertu was neutropenia (11.1%). Interstitial lung disease (ILD) or pneumonitis events occurred in 20.8% of patients treated with Enhertu as determined by an independent adjudication committee. The majority of ILD or pneumonitis events were low grade (grade 1 [n=7; 3.1%] or grade 2 [n=30; 13.3%]). There were five (2.2%) grade 3, one (0.4%) grade 4 and four (1.8%) grade 5 ILD events in the Enhertu arm.

"Enhertu was the first HER2 directed medicine and antibody drug conjugate approved for patients with HER2 mutant non-small cell lung cancer and has become a second-line standard of care treatment," said John Tsai, MD, Global Head of R&D, Daiichi Sankyo. "The progression-free survival benefit of six months and strong response rates seen in DESTINY-Lung04 reinforce the importance of targeting HER2 directly in these patients and support the potential of Enhertu in the first-line setting where delaying disease progression for as long as possible is a critical goal."

"DESTINY-Lung04 is the first phase 3 trial to demonstrate superior progression-free survival versus the global first-line standard of care in patients with HER2 mutant advanced non-small cell lung cancer," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology Hematology R&D, AstraZeneca. "These results add to the growing body of evidence supporting Enhertu as an important treatment for patients with HER2 alterations and underscore its potential role at the time of metastatic diagnosis, when treatment has the greatest opportunity to improve outcomes."

Patients in the DESTINY-Lung04 trial received prior radiotherapy, chemotherapy, immunotherapy or targeted therapy for early-stage disease. Approximately three-quarters (75.8%) of the patients in the Enhertu arm had de novo disease, meaning the lung cancer was first diagnosed in the metastatic setting, and nearly one-quarter (22.9%) had brain metastases at baseline. Median duration of follow-up was 21.6 months with patients receiving Enhertu and 20.4 months with patients receiving pembrolizumab plus chemotherapy. As of the data cut-off date of June 9, 2026, 50 patients remained on study treatment with 40 patients still receiving Enhertu and 10 patients receiving pembrolizumab plus chemotherapy.

Summary of DESTINY-Lung04 Primary Results

Efficacy Measure

Enhertu (5.4 mg/kg)
(n=227)

Pembrolizumab plus
Chemotherapy
(n=227)

Median PFSi, (months) (95% CI)

14.3 months (12.4-16.5)

8.3 months (7.0-9.9)

HR = 0.63 (0.50-0.79); p<0.0001

ORRii (%) (95% CI)

70.0% (63.6-75.9)

44.5% (37.9-51.2)

CRi,iii, % (n)

1.8% (4)

1.8% (4)

PRi,iii, % (n)

68.3% (155)

42.7% (97)

SDi,iii, % (n)

26.9% (61)

43.2% (98)

Median DORi, (months) (95% CI)

13.4 months (10.4-17.2)

9.7 months (7.0-11.1)

Median PFS2iv, (months) (95% CI)

22.7 months (20.3-26.3)

17.3 months (15.6-21.8)

HR = 0.80 (0.62-1.02)

Median OSv, (months) (95% CI)

29.3 months (26.2-33.4)

33.1 months (27.7-40.7)

HR = 1.15 (0.88-1.52)

CI, confidence interval; CR, complete response; DOR, duration of response; ORR, objective response rate; OS, overall survival; PFS, progression-free survival; PR, partial response; SD, stable disease
i Assessed by BICR
ii ORR is (CR + PR)
iii Includes unconfirmed responses
iv Assessed by investigator
v At DCO, overall data maturity for OS was 46.9%. No formal hypothesis testing was performed at this interim analysis; formal hypothesis testing will be performed at the second interim analysis and final analysis

About DESTINY-Lung04
DESTINY-Lung04 is a global, randomized, open-label, phase 3 trial evaluating the efficacy and safety of Enhertu (5.4 mg/kg) compared to standard of care (platinum-pemetrexed doublet chemotherapy in combination with pembrolizumab) in patients with unresectable, locally advanced or metastatic, non-squamous NSCLC harboring a HER2 exon 19 or 20 mutation.

Patients were randomized 1:1 to receive either Enhertu or standard of care. Randomization was stratified by smoking history and presence or history of brain metastasis. The primary endpoint of DESTINY-Lung04 is PFS as assessed by BICR. Secondary endpoints include OS, investigator-assessed PFS, ORR and DOR as assessed by BICR and investigator, investigator-assessed PFS2, pharmacokinetics and safety.

DESTINY-Lung04 enrolled 454 patients across multiple sites in Asia, Europe and North America. For more information about the trial, visit ClinicalTrials.gov.

About HER2 Mutant NSCLC
Lung cancer is the most commonly diagnosed cancer globally and remains the leading cause of cancer-related death.1 In 2024, approximately 2.6 million new lung cancer cases were reported worldwide, with an estimated 1.8 million deaths.1 NSCLC is the most common type of lung cancer, accounting for approximately 85% of cases.2 Prognosis is particularly poor for patients with metastatic NSCLC as only approximately 10% will live beyond five years after diagnosis.3,4,5

HER2 is a tyrosine kinase receptor protein involved in cell growth and differentiation and expressed on the surface of multiple tumor types. HER2 mutations have been identified in NSCLC as distinct molecular targets and have been reported in approximately 2% to 4% of patients with non-squamous NSCLC.6,7,8,9 These HER2 mutations are predominantly seen in younger women and people with no smoking history and have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.6,10,11,12,13,14

The current global standard of care in the first-line metastatic setting of patients with HER2 mutant NSCLC has been a combination of immunotherapy and doublet platinum-based chemotherapy.15,16,17 Response rates with this treatment regimen have been limited and many patients experience disease progression, underscoring the need for additional treatment options.18

About Enhertu
Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the U.S. only) is a HER2 directed ADC. Designed using the proprietary DXd ADC Technology of Daiichi Sankyo, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4 mg/kg) followed by THP is approved in Brazil, China, India, Singapore, Taiwan and the U.S. as a neoadjuvant treatment for adult patients with HER2 positive (IHC 3+ or ISH+) stage 2 or stage 3 breast cancer based on the results from the DESTINY-Breast11 trial. Continued approval in China for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (5.4 mg/kg) is approved in Brazil, Canada, India and the U.S. for the adjuvant treatment of adult patients with HER2 positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab (with or without pertuzumab) and taxane-based treatment based on the DESTINY-Breast05 trial.

Enhertu (5.4 mg/kg) in combination with pertuzumab is approved in more than 40 countries/regions worldwide as a first-line treatment for adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer, as determined by a locally or regionally approved test, based on the results from the DESTINY-Breast09 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+ or ISH+) breast cancer who have received a prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4 mg/kg) is approved in more than 75 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic hormone receptor (HR) positive, HER2 low (IHC 1+ or IHC 2+/ ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer, as determined by a locally or regionally approved test, that have progressed on one or more endocrine therapies in the metastatic setting based on the results from the DESTINY-Breast06 trial.

Enhertu (5.4 mg/kg) is approved in more than 100 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4 mg/kg) is approved in more than 80 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials. Continued approval in China and the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4 mg/kg) is approved in more than 90 countries/regions worldwide for the treatment of adult patients with locally advanced or metastatic HER2 positive (IHC 3+ or IHC 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric04 trials.

Enhertu (5.4 mg/kg) is approved in more than 45 countries/regions worldwide for the treatment of adult patients with unresectable or metastatic HER2 positive (IHC 3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01, DESTINY-CRC02 and/or HERALD trials. Continued approval in the U.S. for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

About the Enhertu Clinical Development Program
A comprehensive global clinical development program is underway evaluating the efficacy and safety of Enhertu as a monotherapy or in combination or sequentially with other cancer medicines across multiple HER2 targetable cancers.

(Press release, Daiichi Sankyo, SEP 13, 2026, View Source [SID1234670784])

On September 13, 2026 Akeso, Inc. (9926.HK) reported the presentation of positive overall survival (OS) results from the randomized, double-blind, multicenter, registrational Phase III HARMONi-2 study (AK112-303) at the 2026 World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC). The study evaluated the company’s first-in-class next-generation immuno-oncology therapy, ivonescimab, versus pembrolizumab as first-line treatment for patients with PD-L1-positive (PD-L1 TPS ≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The findings were selected as a Late-Breaking Abstract (LBA) for oral presentation and included in the official WCLC press program.

On September 13, the WCLC official website published the Abstract data on overall survival (OS) from the HARMONi-2 study. On September 15, Professor Caicun Zhou, Principal Investigator of HARMONi-2, IASLC President, and Director of the Department of Oncology at Shanghai East Hospital, will deliver the formal oral presentation (Oral) at the conference, sharing the complete results of the HARMONi-2 study with the global industry.

As of the data cutoff on August 20, 2026, the median follow-up was 36 months, and a total of 234 overall survival (OS) events had occurred. For this OS analysis, a prespecified O’Brien-Fleming spending function was used, with a one-sided alpha of 0.0141.

Results showed that, compared with pembrolizumab, first-line treatment with ivonescimab significantly prolonged OS in patients with PD-L1-positive advanced NSCLC. This finding met the prespecified statistical significance threshold and demonstrated clear clinical benefit. The overall survival benefit was generally consistent across prespecified subgroups, with particularly pronounced benefit observed in the PD-L1-high population.

1. Intention-to-Treat (ITT) Population: Median OS of 30.8 Months with Ivonescimab, 27% Reduction in Risk of Death

In the ITT population, ivonescimab monotherapy significantly prolonged OS versus pembrolizumab, with median OS of 30.8 months versus 22.6 months (HR=0.73; 95% CI: 0.57–0.95; P=0.009), corresponding to a 27% reduction in the risk of death.
2. Overcoming Traditional Anti-VEGF Treatment Contraindications: No Significant Increase in Bleeding Risk Observed in High-Risk Squamous Patients

Squamous NSCLC patients accounted for 45.5% of the HARMONi-2 population, and non-squamous patients for 54.5%. Among squamous patients treated with ivonescimab, 72.2% had central tumors, 10.0% had tumor cavitation or necrosis, and 6.7% had tumors encasing major vessels.

These populations are traditionally considered contraindicated or high-risk for anti-VEGF therapies and have long lacked effective treatment options. However, no apparent increase in bleeding risk was observed with ivonescimab, and these patients showed favorable benefit.

3. Consistent OS Benefit with Ivonescimab Regardless of PD-L1 Expression Level, with Particularly Pronounced Benefit in the TPS ≥50% Population

In the PD-L1 TPS ≥50% subgroup, OS HR=0.58 (95% CI: 0.38–0.89), corresponding to a 42% reduction in the risk of death.
In the PD-L1 TPS 1–49% subgroup, OS HR=0.85 (95% CI: 0.61–1.18), corresponding to a 15% relative reduction in the risk of death.
4. Consistent OS Benefit with Ivonescimab Regardless of Histology (Squamous and Non-Squamous)

In the squamous cell carcinoma subgroup, OS HR=0.65 (95% CI: 0.45–0.95), corresponding to a 35% reduction in the risk of death.
In the non-squamous subgroup, OS HR=0.79 (95% CI: 0.55–1.14), corresponding to a 21% reduction in the risk of death.
5. Favorable Overall Safety Profile with No New Safety Signals; Safety Characteristics Generally Consistent Between Arms

In May 2024, a prespecified interim analysis of progression-free survival (PFS) assessed by the Independent Data Monitoring Committee (IDMC) confirmed that HARMONi-2 met its primary PFS endpoint with statistically significant and clinically meaningful results. Median PFS was 11.14 months with ivonescimab versus 5.82 months with pembrolizumab (HR=0.51, P<0.0001). This indication was approved in China in 2025.

HARMONi-2 is the first randomized, double-blind, controlled Phase III clinical study to demonstrate statistically significant positive OS and PFS results versus pembrolizumab.

An international multicenter Phase III clinical study evaluating ivonescimab monotherapy versus pembrolizumab as first-line treatment for PD-L1-high NSCLC (HARMONi-7/AK112-3007) is currently progressing efficiently.

To date, ivonescimab has consistently achieved dual-positive OS and PFS results across multiple Phase III head-to-head trials against PD-1/L1 therapies and continues to expand into major solid tumors beyond lung cancer. The synergistic antitumor effects of ivonescimab’s dual "immuno-oncology + anti-angiogenesis" mechanism continue to be validated in both clinical research and real-world settings. Ivonescimab has the potential to provide a more effective treatment option with a manageable safety profile for cancer patients worldwide and to drive continued progress in oncology care.

(Press release, Akeso Biopharma, SEP 13, 2026, View Source [SID1234670782])

On September 13, 2026 Gilead sciences reported that Sacituzumab govitecan (SG) plus pembrolizumab did not demonstrate a statistically significant improvement in progression-free survival compared with pembrolizumab alone as first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) and PD-L1 tumor proportion score (TPS) of 50% or greater, according to primary results from the Phase 3 EVOKE-03/KEYNOTE-D46 trial presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the study, median progression-free survival (PFS) by blinded independent central review was 11.8 months with SG plus pembrolizumab compared with 7.7 months with pembrolizumab alone (HR, 0.81; 95% CI, 0.66-1.00; P=0.0252). Although PFS was numerically longer with the combination, the result did not meet the prespecified threshold for statistical significance. At the interim analysis, median overall survival was 21.5 months with SG plus pembrolizumab and 22.8 months with pembrolizumab alone (HR, 1.07; 95% CI, 0.85-1.35; P=0.7155).

"While the combination of sacituzumab govitecan and pembrolizumab produced a numerically longer progression-free survival and a higher response rate, EVOKE-03/KEYNOTE-D46 did not meet statistical significance for its primary PFS endpoint, and overall survival was not significantly improved at this interim analysis," said Giannis Mountzios, M.D., of the Henry Dunant Hospital Center, Athens, Greece. "These findings provide important information as we continue to evaluate treatment strategies for patients with PD-L1-high metastatic NSCLC."

EVOKE-03/KEYNOTE-D46 is an open-label Phase 3 study that enrolled 620 patients with previously untreated metastatic NSCLC, PD-L1 TPS of at least 50%, and no EGFR, ALK or ROS1 alterations. Participants were randomized to receive SG at 10 mg/kg intravenously on days 1 and 8 plus pembrolizumab 200 mg intravenously on day 1 of each 21-day cycle, or pembrolizumab alone. The dual primary endpoints were PFS by blinded independent central review and overall survival.

The confirmed objective response rate was higher with SG plus pembrolizumab than with pembrolizumab alone. The abstract reports an objective response rate of 55.6% for the combination and 43.7% for pembrolizumab alone. The disease control rate reported in the study table was 83.3% versus 73.1%, respectively, and median duration of response was 21.4 months versus 21.3 months.

Treatment-related adverse events occurred in 93.2% of patients receiving SG plus pembrolizumab and 65.4% of those receiving pembrolizumab alone. Grade 3 or higher treatment-related adverse events occurred in 55.7% and 16.5% of patients, respectively. The most common treatment-related adverse events in the combination arm included anemia, alopecia, neutropenia, diarrhea and nausea. The safety profile was consistent with the known profiles of the individual agents, with no new or additional toxicities observed with the combination.

Dr. Mountzios concluded that, despite a numerical improvement in PFS and a higher response rate, SG plus pembrolizumab did not meet statistical significance for PFS compared with pembrolizumab monotherapy in patients with untreated PD-L1-high metastatic NSCLC Overall survival also did not meet statistical significance at the interim analysis.

(Press release, Gilead Sciences, SEP 13, 2026, View Source [SID1234670781])

On September 13, 2026 MediLink Therapeutics reported the phase III TAISHAN-302 trial found that tambotatug pelitecan (Tam-Peli, YL201), a novel anti-B7-H3 antibody-drug conjugate, significantly improved overall survival, progression-free survival and objective response rate compared with topotecan in patients with relapsed small-cell lung cancer (SCLC). The findings were presented at the International Association for the Study of Lung Cancer (IASLC) 2026 World Conference on Lung Cancer (WCLC).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Relapsed SCLC remains a highly aggressive disease with limited effective treatment options and poor outcomes following first-line immunotherapy and platinum-based chemotherapy. Topotecan has long been a standard second-line treatment, but its survival benefit remains modest. TAISHAN-302 evaluated Tam-Peli as a second-line treatment for patients whose SCLC had relapsed after first-line therapy.

The randomized, open-label study enrolled 451 patients, with 225 assigned to Tam-Peli and 226 to topotecan. Patients receiving Tam-Peli were treated with 2.0 mg/kg intravenously on day 1 of each three-week cycle, with a maximum dose of 200 mg. Treatment continued until disease progression or unacceptable toxicity. The study’s primary endpoint was overall survival, with progression-free survival and objective response rate as key secondary endpoints.

As of May 20, 2026, after a median follow-up of 9.4 months, median overall survival was 13.3 months with Tam-Peli compared with 9.4 months with topotecan. Tam-Peli reduced the risk of death by 54% (HR 0.46; 95% CI 0.35–0.62; p<0.0001). The survival benefit was consistent across prespecified subgroups, including patients with brain metastases, liver metastases and a chemotherapy-free interval of less than 90 days.

Tam-Peli also significantly improved progression-free survival. Median progression-free survival was 7.4 months with Tam-Peli versus 2.8 months with topotecan, representing a 71% reduction in the risk of disease progression or death (HR 0.29; 95% CI 0.23–0.37; p<0.0001). The objective response rate was 59.1% with Tam-Peli compared with 9.7% with topotecan (p<0.0001).

The safety profile of Tam-Peli was considered manageable and consistent with its known profile, with no new safety signals identified. Grade 3 or higher treatment-related adverse events occurred in 46.4% of patients receiving Tam-Peli compared with 74.7% receiving topotecan, and there were no treatment-related deaths in the Tam-Peli arm. Treatment-emergent interstitial lung disease or pneumonitis occurred in 4.9% of patients receiving Tam-Peli and 1.4% receiving topotecan; grade 3 events occurred in 0.9% of patients in each group, with no grade 4 or 5 events reported.

"TAISHAN-302 is among the first phase III studies of an antibody-drug conjugate to demonstrate statistically significant and clinically meaningful improvements in overall survival, progression-free survival and objective response rate compared with topotecan in relapsed small-cell lung cancer," said Professor Li Zhang of Sun Yat-sen University Cancer Center, Guangzhou, China. "Together with a generally favorable and manageable safety profile, these results support Tam-Peli as a potential new standard-of-care option for second-line SCLC and may reshape the treatment landscape for this challenging disease."

(Press release, Suzhou Medilink Therapeutics, SEP 13, 2026, View Source [SID1234670780])

On September 13, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently develop improved antibody drug conjugate (ADC) cancer treatments, reported the presentation of two real-world analyses supporting protein tyrosine kinase 7 (PTK7) as a durable and clinically relevant ADC target in patients with pretreated, EGFR wild-type non-small cell lung cancer (NSCLC). The data will be presented at the IASLC 2026 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer, taking place September 12-15, 2026, in Seoul, Republic of Korea.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In tumor samples from patients with EGFR wild-type lung adenocarcinoma, PTK7 expression remained largely stable following standard-of-care (SoC) treatments, including chemotherapy and immunotherapy, and demonstrated less treatment associated variation than several other ADC targets in late-stage development. PTK7 expression was also generally consistent regardless of the presence or absence of other actionable genomic alterations (AGA). These findings indicate PTK7 remains available for targeted ADCs for patients that have progressed through multiple lines of SoC therapy and across clinically relevant subgroups.

A separate analysis of patients with advanced EGFR wild-type lung adenocarcinoma found that real-world overall survival was not impacted based on PTK7-expression, supporting PTK7 as a target-engagement biomarker for ADC payload delivery independent of prognosis in NSCLC.

"The development strategy for our PTK7-directed ADC, HWK-007, is grounded in understanding not only where PTK7 is expressed, but also how that expression behaves in a real-world treatment setting," said Margaret Dugan, MD, Chief Medical Officer of Whitehawk Therapeutics. "The stability of PTK7 expression after standard of care therapies, in particular compared to other therapies in late-stage development, add important translational context as we evaluate HWK-007 in patients with EGFR wild-type NSCLC."

Key Findings:

Durable and Treatment-Agnostic PTK7 Expression in EGFR Wild-Type Lung Adenocarcinoma Supports Targeted ADC Development

PTK7 expression remained largely stable following standard-of-care immunotherapy, chemotherapy, chemoimmunotherapy and tyrosine kinase inhibitor treatment, suggesting that the target may remain available for PTK7-directed therapy after prior treatment.
Stable PTK7 expression is also observed in paired tumor samples.
PTK7 demonstrated less treatment-associated variation than several late-stage ADC targets, including MET, PD-L1 and ITGB6.
PTK7 expression was generally consistent across tumors with or without other AGA, including KRAS G12C, ALK and MET alterations, suggesting relevance of PTK7 as an ADC target across both AGA+ and AGA- NSCLC subgroups.
Association Between PTK7 Expression and Real-World Survival in Pretreated Patients With EGFR Wild-Type Lung Adenocarcinoma

PTK7 expression was not independently associated with real-world overall survival or progression-free survival in patients with advanced EGFR wild-type lung adenocarcinoma receiving second- or later-line therapy, supporting PTK7 as a target-engagement biomarker rather than a marker of prognosis.
Clinical outcomes were driven primarily by established prognostic factors, including Eastern Cooperative Oncology Group performance status and extent of prior therapy.
PTK7-low tumors were enriched for KEAP1 and STK11 alterations, suggesting biological heterogeneity of EGFR wild-type NSCLC.
"Understanding whether a therapeutic target remains present after prior treatment is particularly important in advanced lung cancer, where patients often receive multiple lines of therapy," said Aaron E. Lisberg, MD, Associate Professor of Medicine at the David Geffen School of Medicine at UCLA. "The stability of PTK7 expression across standard treatments and clinically relevant molecular subgroups supports further investigation of PTK7-directed ADCs in patients with previously treated EGFR wild-type lung adenocarcinoma."

Poster Presentation Details:

Title: Durable and Treatment-Agnostic PTK7 Expression in EGFR Wild-Type Lung Adenocarcinoma Supports Targeted ADC Development
Poster: P2.241
Presenter: Aaron E. Lisberg, MD, University of California Los Angeles, Los Angeles, CA, USA
Date & Time: Monday, September 14, 2026, at 10:30 AM KST

Title: Association Between PTK7 Expression and Real-World Survival in Pretreated Patients With EGFR Wild-Type Lung Adenocarcinoma
Poster: P2.147
Presenter: Grace Dy, MD, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA
Date & Time: Monday, September 14, 2026, at 10:30 AM KST

HWK‑007 is PTK7-directed, next-generation ADC being evaluated in an ongoing Phase 1 clinical trial in patients with non-squamous, EGFR wild-type NSCLC, platinum-resistant ovarian cancer and endometrial cancer (NCT07444814).

These analyses were conducted as part of a previously announced collaboration between Whitehawk and Tempus AI. The posters will be accessible on the Presentations page of the Investors & News section of the Company’s website at www.whitehawktx.com.

(Press release, Whitehawk Therapeutics, SEP 13, 2026, View Source [SID1234670779])