Apollomics Presents Vebreltinib Data in Patients with Non-Small Cell Lung Cancer with METex14 Skipping Mutations at European Society for Medical Oncology (ESMO) Congress 2024

Rhea-AI Summary

Apollomics Inc. (Nasdaq: APLM) presented data on vebreltinib for non-small cell lung cancer (NSCLC) with METex14 skipping mutations at the ESMO Congress 2024. Key findings include:

1. Efficacy in both treatment-naïve and previously treated patients:
- Treatment-naïve: 66.7% overall response rate (ORR), 17.3 months median duration of response (DOR), 13.8 months median progression-free survival (PFS)
- Previously treated: 61.1% ORR, 16.7 months median DOR, 7.4 months median PFS

2. Efficacy regardless of MET gene copy number (GCN):
- GCN<4: 67.8% ORR
- GCN<6: 69.2% ORR
- GCN>4: 100% ORR (5/5 patients)

3. Safety profile: 48.1% of patients experienced grade 3 or higher treatment-related adverse events, with edema being most common (16.7%). No deaths were reported due to treatment-emergent adverse events.

Positive

• High overall response rates (ORR) in both treatment-naïve (66.7%) and previously treated (61.1%) NSCLC patients with METex14 skipping mutations
• Long median duration of response (DOR) of 17.3 months in treatment-naïve and 16.7 months in previously treated patients
• Efficacy demonstrated across different MET gene copy number (GCN) subgroups, including 67.8% ORR in GCN<4 cohort
• Vebreltinib outperformed other MET inhibitors in patients with GCN<4
• 100% ORR observed in the GCN>4 cohort (5/5 patients)

Negative

• 48.1% of patients experienced grade 3 or higher treatment-related adverse events
• Edema reported as the most common adverse event (16.7% of patients)

Insights

Oncology Researcher

The data presented on vebreltinib for NSCLC patients with METex14 skipping mutations is promising. The 66.7% ORR in treatment-naïve patients and 61.1% ORR in previously treated patients are impressive, especially considering the median DOR of 17.3 and 16.7 months respectively. These results suggest durable responses, which is important in oncology.

The efficacy across different MET gene copy numbers (GCN) is noteworthy. The 67.8% ORR in GCN<4 patients outperforms other MET inhibitors significantly. This indicates vebreltinib's potential as a best-in-class therapy for this specific mutation, addressing a broader patient population.

Safety profile seems manageable, with edema being the most common grade 3+ TRAE. However, the 48.1% rate of grade 3+ TRAEs warrants careful monitoring in clinical practice.

Market Research Analyst

Apollomics' vebreltinib data presents a strong market opportunity. The drug's efficacy across different patient subgroups, including treatment-naïve and previously treated, as well as various MET gene copy numbers, positions it as a potentially versatile treatment option.

The outperformance compared to other MET inhibitors, especially in the GCN<4 subgroup, could be a significant differentiator in the market. This could lead to higher adoption rates and potentially larger market share if approved.

However, investors should note that while the data is promising, the sample size is relatively small (108 patients) and longer-term follow-up data will be important to solidify vebreltinib's position. The safety profile, while manageable, may require comparison with standard-of-care options to fully assess its competitive advantage.

Vebreltinib is efficacious in both treatment naïve and previously treated patients with NSCLC with METex14 skipping, and regardless of co-occurring MET amplification

FOSTER CITY, Calif., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Apollomics Inc. (Nasdaq: APLM) (“Apollomics” or the “Company”), a late-stage clinical biopharmaceutical company developing multiple oncology drug candidates to address difficult-to-treat and treatment-resistant cancers, announced today a poster presentation at the 2024 European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024 in Barcelona, Spain.

“We are pleased to share the efficacy and safety data of vebreltinib showing it is efficacious in both treatment naïve and previously treated patients with non-small cell lung cancer (NSCLS) and confirmed METex14 mutation, with longer treatment follow-ups,” said Guo-Liang Yu, Ph.D., Chairman and Chief Executive Officer of Apollomics. “Interestingly, the analysis of efficacy by MET gene copy number (GCN) demonstrated that not only the majority of the patient population in the vebreltinib program does not have co-occurring MET amplification and therefore resembles the real-world patient population reported in registries, but also that vebreltinib is efficacious regardless of co-occurring METamp, achieving as high as 67% overall response rate in patients with MET GCN<4, and outperforming other MET inhibitors. The data further supports verbreltinib’s high potency and its best-in-class potential.”

The poster presentation titled “Vebreltinib Efficacy and Safety in NSCLC Patients with METex14 Skipping Mutations” highlighted data from the ongoing global Phase 2 SPARTA-II trial and the Company’s partner, Avistone, Phase 2/3 KUNPENG trial in China. The analysis of the data included 108 patients without prior exposure to MET inhibitors (72 treatment-naive and 36 previously treated NSCLC patients) that received vebreltinib, 200 mg BID in 28-day cycle, with 12 months of follow up data. With centrally confirmed METex14 skipping, overall response rate (ORR) to vebreltinib in treatment-naïve patients was 66.7% (95% CI: 54.6, 77.3) with median duration of response (DOR) of 17.3 months and median progression free survival (PFS) of 13.8 months. In the previously treated patients, ORR was 61.1% (95% CI: 43.5, 76.9) with median DOR of 16.7 months and median PFS of 7.4 months. Among the 91 vebreltinib-treated NSCLC patients with METex14 for whom GCN data was available, GCN distribution was similar to those reported in AACR project GENIE and cBioportal. The ORRs by GCN continue to support vebreltinib’s efficacy, including in the GCN<4 cohort (ORR 67.8%; n=86) - a subgroup that was reported in other MET inhibitor trials to be less responsive: 18% ORR with capmatinib in patients with METex14 NSCLC and GCN<4, and 38.6% with savolitinib in METex14 NSCLC without METamp. Similarly, ORR was 69.2% in GCN<6 (n=91) and 100% (5/5) in GCN>4 cohorts. Treatment-related adverse events (TRAE) of grade 3 or higher were reported in 48.1% of patients, with the most common being edema (16.7%). No death was reported due to TEAEs.

The poster presentation will be available on the Apollomics website under the Presentations page under the News and Events section.

About vebreltinib (APL-101)

Vebreltinib is a potent, small molecule, orally bioavailable and highly selective c-MET inhibitor. It works by inhibiting the aberrant activation of the HGF/c-MET axis, a key pathway involved in tumor growth, proliferation, and the development of resistance to certain targeted therapies such as osimertinib. By targeting c-MET dysregulation, vebreltinib has demonstrated strong tumor inhibitory effect in a variety of preclinical c-MET dysregulated human gastric, hepatic, pancreatic and lung cancer xenograft animal models and patient-derived xenograft models (PDX).

Details on the Phase 1/2 SPARTA global clinical trial can be found on clinicaltrials.gov: NCT03175224. Apollomics is developing vebreltinib as single-agent cancer therapy in a variety of tumor types and actively assessing the potential of vebreltinib in combination with novel therapies. Vebreltinib recently received conditional approval from the National Medical Products Administration (NMPA) of China and is currently under clinical investigation and not approved for any use in any other regions in the world.

About Apollomics Inc. 

Apollomics Inc. is an innovative clinical-stage biopharmaceutical company focused on the discovery and development of oncology therapies with the potential to be combined with other treatment options to harness the immune system and target specific molecular pathways to inhibit cancer. Apollomics’ lead programs include its core product, vebreltinib (APL-101), a potent, selective c-Met inhibitor for the treatment of non-small cell lung cancer and other advanced tumors with c-Met alterations, which is currently in a Phase 2 multicohort clinical trial in the United States, and uproleselan (APL-106), a specific E-Selectin antagonist that has the potential to be used adjunctively with standard chemotherapy to treat acute myeloid leukemia and other hematologic cancers, which is currently in Phase 1 and Phase 3 clinical trials in China. For more information, please visit www.apollomicsinc.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes statements that constitute “forward-looking statements” within the meaning of the federal securities laws, including Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All statements, other than statements of present or historical fact included in this press release, regarding the Company’s strategy, prospects, plans and objectives are forward-looking statements, including statements about the preliminary data from the Phase 2 SPARTA trial of vebreltinib in patients with non-CNS MET fusion solid tumors. When used in this press release, the words “could,” “should,” “will,” “may,” “believe,” “anticipate,” “intend,” “estimate,” “expect,” “project,” the negative of such terms and other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain such identifying words. These forward-looking statements are based on management’s current expectations and assumptions about future events and are based on currently available information as to the outcome and timing of future events. Apollomics cautions you that these forward-looking statements are subject to numerous risks and uncertainties, most of which are difficult to predict and many of which are beyond the control of Apollomics. In addition, Apollomics cautions you that the forward-looking statements contained in this press release are subject to unknown risks, uncertainties and other factors, including: (i) the impact of any current or new government regulations in the United States and China affecting Apollomics’ operations and the continued listing of Apollomics’ securities; (ii) the inability to achieve successful clinical results or to obtain licensing of third-party intellectual property rights for future discovery and development of Apollomics’ oncology projects; (iii) the failure to commercialize product candidates and achieve market acceptance of such product candidates; (iv) the failure to protect Apollomics’ intellectual property; (v) breaches in data security; (vi) the risk that Apollomics may not be able to develop and maintain effective internal controls; (vii) unfavorable changes to the regulatory environment; and (viii) those risks and uncertainties discussed in the Annual Report on Form 20-F for the year ended December 31, 2023, filed by Apollomics Inc. with the U.S. Securities and Exchange Commission (“SEC”) under the heading “Risk Factors” and the other documents filed, or to be filed, by the Company with the SEC. Additional information concerning these and other factors that may impact the operations and projections discussed herein can be found in the reports that Apollomics has filed and will file from time to time with the SEC. These SEC filings are available publicly on the SEC’s website at www.sec.gov. Forward-looking statements speak only as of the date made by the Company. Apollomics undertakes no obligation to update publicly any of its forward-looking statements to reflect actual results, new information or future events, changes in assumptions or changes in other factors affecting forward-looking statements, except to the extent required by applicable law.

Investor Contact:

Eric Ribner
LifeSci Advisors, LLC
(646) 751-4363
eric@lifesciadvisors.com

FAQ

What were the efficacy results of vebreltinib in treatment-naïve NSCLC patients with METex14 skipping mutations (APLM)?

In treatment-naïve NSCLC patients with METex14 skipping mutations, vebreltinib showed an overall response rate (ORR) of 66.7%, a median duration of response (DOR) of 17.3 months, and a median progression-free survival (PFS) of 13.8 months.

How did vebreltinib perform in previously treated NSCLC patients with METex14 skipping mutations (APLM)?

In previously treated NSCLC patients with METex14 skipping mutations, vebreltinib demonstrated an overall response rate (ORR) of 61.1%, a median duration of response (DOR) of 16.7 months, and a median progression-free survival (PFS) of 7.4 months.

What was the efficacy of vebreltinib in NSCLC patients with different MET gene copy numbers (GCN) (APLM)?

Vebreltinib showed efficacy across different MET gene copy numbers (GCN): 67.8% ORR in GCN<4 cohort, 69.2% ORR in GCN<6 cohort, and 100% ORR (5/5 patients) in GCN>4 cohort.

What were the main safety findings for vebreltinib in NSCLC patients with METex14 skipping mutations (APLM)?

The main safety findings for vebreltinib included 48.1% of patients experiencing grade 3 or higher treatment-related adverse events, with edema being the most common (16.7%). No deaths were reported due to treatment-emergent adverse events.