Nasdaq: APLM
Corporate Presentation
April 2024
apollomicsinc.com
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Vebreltinib - A Differentiated cMET Inhibitor Addressing Unmet Need
Significant market
opportunities in NSCLC
combo therapy
Best-in-class
&
First-in-class potential
Regulatory pathway
towards US NDA
- c-Metdysregulated cancers as monotherapy (~12K U.S. patients in lung and brain tumors alone; many more patients with MET dysregulated tumors in other organs)
- ~15-50%of NSCLC patients on targeted therapies (EGFR, KRAS, ALK, ROS) progress due to acquired MET amplification - combo therapy market for treatment resistance & first line
- Best-in-classactivity in Met Exon14 skipping NSCLC patients without co-occurring MET amplification
- First-in-classpotential for Met Amp+ NSCLC, glioblastoma multiforme (GBM) with Met fusions, and others
- FDA accepted pooling of SPARTA (global) and KUNPENG (China trial also known as PEARL) studies for MetEx14 skip NSCLC
- FDA did not require a randomized controlled Phase 3 trial
- Near term NDA 2025/2026 timeframe
3 3
3 Monotherapy Indications
1st Indication | 2nd Indication | 3rd Indication |
Recurrent | ||
1L metastatic | 2L+ NSCLC | |
GBM with | ||
NSCLC with | ||
with c-Met | PTPRZ1-Met | |
Met Exon 14 | ||
Amplification | Fusions | |
skipping | ||
Pivotal Phase 2 study- ongoing | Phase 2 Pivotal Study Enrollment Ongoing, | US Regulatory timeline |
Target NDA submission 2025/2026 | Target NDA submission (US) 2026 | Under assessment |
Launched in China by Avistone | sNDA Approval (China NMPA) | |
NDA approved 11/2023 | granted to Avistone 4/23/2024 | |
4
NSCLC | NSCLC | r/r GBM |
Ex14 Skipping | Amp+ | Met-Fusion |
Vebreltinib for MetEx14 Skip NSCLC Clinical Regulatory Status
- Conditionally approved by NMPA in China, Nov 2023
- FDA meeting July 2023:
- "FDA acknowledged that Apollomics may have a path towards traditional approval in the context of their current clinical trials. FDA recommended that Apollomics should review their development plan and propose an additional meeting to discuss this approach."
- "FDA acknowledged that Apollomics proposal to pool data from SPARTA and PEARL appears acceptable; however, given the limitations stated above a final determination will be made upon review of the data submitted to a potential marketing application."
- FDA meeting Feb 2024: Continue to enroll in 1L MetEx14 NSCLC cohort
- Plan to have preNDA meeting with FDA after additional patients have had 12 months follow up data
5
cMET Inhibitors Landscape
NSCLC | NSCLC | r/r GBM |
Ex14 Skipping | Amp+ | Met-Fusion |
1 | Capmatinib2 | Tepotinib3 | Savolitinib4 | Telisotuzumab5 | Amivantamab6 | ||||||
Vebreltinib | (Tabrecta) | (Tepmetko) | (Orpathys) | (Teliso-V) | (Rybrevant) | ||||||
1L NSCLC with Met | ORR | 66% | 68% | 57% | 46% | ||||||
N | (n=71) | (N=60) | (N=164) | (N=28) | N/A | 57% | |||||
exon 14 skipping | |||||||||||
mDoR | 16.5 mos | 16.6 mos | 40% DoR≥12 mos | 5.6 mos | |||||||
2L+ NSCLC with Met | ORR | 61% | 44% | 45% | 41% | ||||||
N | (n=36) | (N=100) | (N=149) | (N=42) | N/A | 47% | |||||
exon 14 skipping | |||||||||||
mDoR | 16.7 mos | 9.7 mos | 36% DoR≥12 mos | 5.6 mos | |||||||
2L+ cMet Amplified | ORR | Ongoing | 12% GCN 6-10 | 29% | N/A | N/A | Pursuing | ||||
NSCLC de novo | N | 29% GCN >10 | (N=17) | Unpublished | |||||||
Recurrent GBM with PTPRZ1 Met | 48% reduction in | ||||||||||
risk of death in OS; | N/A | N/A | N/A | N/A | N/A | ||||||
fusions | mOS 6.31 vs 3.38 | ||||||||||
mos | |||||||||||
35% Met high | |||||||||||
2L+ cMet | ORR | N/A | N/A | N/A | N/A | 9.0 mos | N/A | ||||
overexpressing NSCLC | mDoR | 23% Met inter | |||||||||
7.2 mos | |||||||||||
1. Data from KUNPENG and SPARTA trial for MetEx14 skip NSCLC | |||||||||||
2. Capmatinb Package Inset from Full Approval; Wolf et al 2020 | |||||||||||
3. Tepotinib package insert from Full Approval; Xuining Le et al 2023 | |||||||||||
4. Savolitinib data from Zhu et al Cancers 2023 | |||||||||||
5. LUMINOSITY trial for monotherapy; Abbvie Press Release Nov 2023 | 6 | ||||||||||
6. CHRYSALIS study Leighl et. al. ESMO 2023 |
NSCLC | NSCLC | r/r GBM | |
Limitation in Capmatinib's Treatment in MetEx14 Skip NSCLC | Ex14 Skipping | Amp+ | Met-Fusion |
Especially in MetEx14 Skip NSCLC patients without overlapping Met Amp (GCN<4)
- Capmatinib Accelerated Approval (N=97)
- 1L ORR 68% (n=28)
- 2L+ ORR 41% (n=69)
- 82 patients with GCN data available:
- ORR 18% in patients with GCN<4 (no co-occurring MET amplification)
- Capmatinib Regular Approval (N=160)
- 1L ORR 68% (n=60)
- 2L+ ORR 44% (n=100)
- No additional efficacy data by GCN subgroup Available
Unmet Medical Need:
Need more effective treatment for patients with MetEx14 skip NSCLC and no co-occurring MET amplification (GCN<4)
Overall Response Rate (ORR)
70%
60%
50%
40%
30%
20%
10%
0%
Capmatinib ORR in NSCLC with MetEx14 Skip by GCN
count in the 82 patients with GCN
57% 60%
38%
18%
n=22 | n=47 | n=35 | n=15 |
GCN<4 | GCN<6 | GCN >=6 | GCN>=10 |
7
MetEx14 skip NSCLC Study Populations by GCN Subgroups | NSCLC | NSCLC | r/r GBM | ||
Ex14 Skipping | Amp+ | Met-Fusion | |||
In patients with available GCN data in SPARTA & KUNPENG studies | |||||
Vebreltinib Dataset Resembles Real World
Patient Samples
Patient Distribution by GCN (%)
Vebreltinib Efficacious In All GCN Subgroups
Regardless of MET Amplification
ORR in GCN Subgroups | 100% | |
100% | ||
90% | ||
Vebreltinib (n=91)
capmatinib (n=82)
cBioportal (n=157)
AACR Genie (n=421)
26.8%
94.5% patients with GCN <4
89.2%
83.6%
Overall Response Rate (ORR)
80% | ||
67% | 69% | |
70% | ||
57% | ||
60% | ||
50% | ||
38% | ||
40% | ||
30% | ||
18% | ||
20% | ||
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
GCN<4 4≤GCN<6 GCN >=6
- GCN<4 no over-lapping MET Amplification
- GCN ≥6 over-lapping MET Amplification
10% | ||||
n=22 | n=86 | n=47 n=90 | n=35 n=1 | |
0% | ||||
GCN<4 | GCN<6 | GCN >=6 | ||
Capmatinib
(N=83, GEOMETRY) (n=91, SPARTA+KUNPENG) | 8 |
Capmatinib data source: Summary basis for approval, page 78.
MexEx14 Skip NSCLC Patients In
SPARTA (Global Study) & KUNPENG (China Study)
NSCLC | NSCLC | r/r GBM |
Ex14 Skipping | Amp+ | Met-Fusion |
SPARTA | KUNPENG (Pearl II) | ||
Multicohort Open-Label Phase II study | | | |
Primary endpoint ORR based on RECIST 1.1, supported by DOR | |||
Regions | US, Canada, EU, | China | |
APAC (ex-China) | |||
Sponsor | Apollomics | Avistone | |
MET exon 14 skipping NSCLC: include 1L & 2L+ patients | | | |
identified by NGS, unresectable or metastatic disease | |||
Treatment: vebreltinib 200 mg BID | | | |
1L patients (efficacy set for US NDA) | N=36 | N=35 | |
GCN<4: | n=28; ORR 64.3% | n=28; ORR 71.4% | |
Median age, years (range) | 75.0 (53, 86) | 71.0 (53, 90) | |
Female (%) | 58.3% | 48.6% | |
Non-smokers | 52.8% | 65.7% | |
ECOG 0 | 33.3% | 14.3% | |
ECOG 1 | 66.7% | 85.7% | |
Histology at diagnosis: % Adenoma | 88.9% | 88.6% | 9 |
Notes: KUNPENG - ESMO 2023 Poster; SPARTA - Internal Data
MetEx14 Skip NSCLC
NSCLC | NSCLC | r/r GBM |
Ex14 Skipping | Amp+ | Met-Fusion |
1L NSCLC Patients | 2L+ NSCLC Patients | |||||||
MetEx14 Skip NSCLC | SPARTA-II | Pearl-II | Combined | Capmatinib | SPARTA-II* | Pearl-II | Combined | Capmatinib |
CCAS[1] | (KUNPENG) | (KUNPENG) | ||||||
(N=36) | (N=35) | (N=71) | (N = 60) | (N=19) | (N=17) | (N=36) | (N = 100) | |
Confirmed ORR | 55.6% | 77.1% | 66.2% | 68% | 52.6% | 70.6% | 61.1% | 44% |
95% CI | (38.1, 72.1) | (59.9, 89.6) | (54.0, 77.0) | (55, 80) | (28.9, 75.6) | (44.0, 89.7) | (43.5, 76.9) | (34, 54) |
mDOR (Months) | 11.2 | 17.1 | 16.5 | 16.6 | 10.6 | 16.7 | 16.7 | 9.7 |
95% CI | 6.0, NE | 9.2, NE | 9.2, 23.0 | (8.4, 22.1) | 1.1, NE | 3.7, NE | 5.4, NE | (5.6, 13.0) |
DOR >= 12 Months | 35.8% | 60.5% | 52.2% | 49% | 30.9% | 61.4% | 53.8% | 36% |
DCR (%) | 91.7% | 97.1% | 94.4% | 73.7% | 94.1% | 83.3% | ||
95% CI | (77.5, 98.2) | (85.1, 99.9) | (86.2, 98.4) | (48.8, 90.9) | (71.3, 99.9) | (67.2, 93.6) |
- Patients who first dosed prior to 2023-05-31 in SPARTA-II CCAS population and patients who first dosed prior to 2021-12-31 in Pearl-II are included. * Patients with last IO use < 90 days in SPARTA-II are excluded.
Based on data available up to 2023-10-26
Patients with central tissue NGS confirmed MetEx14 Skip NSCLC NE = Not estimable yet
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Apollomics Inc. published this content on 25 April 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 25 April 2024 12:45:05 UTC.