ASCO 2021 Investor Presentation June 8, 2021
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ASCO 2021 Investor Presentation June 8, 2021
Forward Looking Statement
This presentation contains statements about the Company’s future plans and prospects
that constitute forward-looking statements for purposes of the safe harbor provisions
under the Private Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated as a result of various important factors, including those
discussed in the company’s most recent annual report on Form 10-K and reports on
Form 10-Q and Form 8-K. These documents are available from the SEC, the Bristol-Myers
Squibb website or from Bristol-Myers Squibb Investor Relations.
In addition, any forward-looking statements represent our estimates only as of the date
hereof and should not be relied upon as representing our estimates as of any subsequent
date. While we may elect to update forward-looking statements at some point in the
future, we specifically disclaim any obligation to do so, even if our estimates change.
Not for Product Promotional Use 2
ASCO 2021
Samit Hirawat
Executive VP
Chief Medical Officer
Global Drug Development
Not for Product Promotional Use 3
BMS continues to advance its leadership in Oncology
• Only company with three I-O agents: Opdivo, Yervoy & Relatlimab*
• Broad program across approaches, tumors, and stages of disease
What we’ve learned at ASCO 2021:
—Neo-adjuvant NSCLC (CM-816): following positive pCR results,
favorable surgical outcomes post treatment
GI cancer: favorable data with CM-648 complements upper GI program
Dual I-O (Opdivo + Yervoy): continued long-term survival
Relatlimab: clinically meaningful data in melanoma, for novel fixed-
dose combination with Opdivo
*Opdivo & Yervoy are approved therapies; Relatlimab is a potential new medicine with positive Phase 3 results Not for Product Promotional Use 4
Expanding Opdivo use in early-stage disease:
CM-816 in lung
April 2021: Primary endpoint of pCRa met for ASCO 2021: Greater percentage of patients treated with
neoadjuvant Nivo + chemo, vs chemo neoadjuvant NIVO + chemo had definitive surgery
Primary endpoint: ITT (ypT0N0)b
40 OR = 13.94 (99% CI, 3.49–55.75)c
P < 0.0001
30 Differencec
21.6%
pCR rate (%)
24.0%d
20
10
2.2%d
0 • Majority of pts had surgery within the protocol-specified time window
NIVO + chemo Chemo • Completeness of resection was higher
n/N 43/179 4/179
• Fewer patients underwent pneumonectomy
a Per BIPR; pCR: 0% residual viable tumor cells in both primary tumor (lung) and sampled lymph nodes;
b ITT principle: patients who did not undergo surgery counted as non-responders for primary analysis; • Treatment was tolerable, addition of 5NIVO to chemo did not increase
c Calculated by stratified Cochran–Mantel–Haenszel method;
d pCR rates 95% CI: NIVO + chemo, 18.0–31.0; chemo, 0.6–5.6 post-surgical complications
aPatientswith all baseline stages of disease and definitive surgery;
bDenominator based on patients with definitive surgery;
cThoracoscopic/robotic;
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dMinimally invasive to thoracotomy
CheckMate -648:
Global, randomized, open-label phase 3 studya
Key eligibility criteria n = 321 NIVO 240 mg Q2W + Primary endpoints:
• Unresectable advanced, recurrent
chemo (fluorouracil + cisplatin)d Q4We
or metastatic ESCC • OS and PFSf
• ECOG PS 0-1 (tumor cell PD-L1 ≥ 1%)
R n = 325 NIVO 3 mg/kg Q2W +
• No prior systemic treatment for Secondary endpoints:
advanced disease
1:1:1 IPI 1 mg/kg Q6We
• Measurable disease • OS and PFSf (all randomized)
n = 324 Chemo (fluorouracil + cisplatin)d Q4We • ORRf (tumor cell PD-L1 ≥ 1%
Stratification factors and all randomized)
• Tumor cell PD-L1 expression
N = 970
(≥ 1% vs < 1%b)
• Region (East Asiac vs rest of Asia vs ROW)
• ECOG PS (0 vs 1)
• Number of organs with metastases
(≤ 1 vs ≥ 2)
At data cutoff (January 18, 2021), the minimum follow-up was 12.9 monthsg
aClinicalTrials.gov.
NCT03143153; b< 1% includes indeterminate tumor cell PD-L1 expression; determined by PD-L1 IHC 28-8 pharmDx assay (Dako); cEast Asia includes patients from Japan, Korea, and
Taiwan; dFluorouracil 800 mg/m2 IV daily (days 1-5) and cisplatin 80 mg/m2 IV (day 1); eUntil documented disease progression (unless consented to treatment beyond progression for NIVO + IPI or NIVO +
chemo), discontinuation due to toxicity, withdrawal of consent, or study end. NIVO is given alone or in combination with IPI for a maximum of 2 years; fPer blinded independent central review (BICR);
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gTime from last patient randomized to clinical data cutoff.
CheckMate -648 OS: NIVO + chemo vs. chemo
Primary endpoint (tumor cell PD-L1 ≥ 1%)a All randomizeda
100 NIVO + chemo Chemo 100 NIVO + chemo Chemo
(n = 158) (n = 157) (n = 321) (n = 324)
90 12-mo 90
Median OS, mo 15.4 9.1 Median OS, mo 13.2 10.7
80 rate (95% CI) (11.9–19.5) (7.7–10.0) 80 (95% CI) (11.1–15.7) (9.4–11.9)
HR (99.5% CI) 0.54 (0.37–0.80) 12-mo HR (99.1% CI) 0.74 (0.58–0.96)
Overall survival (%)
70 70
P value < 0.0001 rate P value 0.0021
60 58% 60
53.5%
50 50
40 37% 40 44%
30 30
NIVO + chemo NIVO + chemo
20 20
10 10
Chemo Chemo
0 0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 0 3 6 9 12 15 18 21 24 27 30 33 36 39 42
No. at risk Months Months
NIVO + chemo 158 143 129 105 88 70 53 36 22 16 4 2 0 0 321 293 253 203 163 133 92 60 40 26 12 4 1 1 0
Chemo 157 135 105 72 52 36 21 12 8 4 2 1 1 0 324 281 229 171 131 93 56 41 23 9 5 2 1 0 0
• Superior OS was observed for NIVO + chemo versus chemo in both patients with tumor cell PD-L1 ≥ 1% and all randomized patients
― Patients with tumor cell PD-L1 ≥ 1%: 46% reduction in the risk of death and a 6.3-month improvement in median OS
― All randomized patients: 26% reduction in the risk of death and a 2.5-month improvement in median OS
aMinimum follow-up 12.9 months. Not for Product Promotional Use 7
CheckMate -648 OS: NIVO + IPI vs. chemo
All randomizeda
Primary endpoint (tumor cell PD-L1 ≥ 1%)a
100 NIVO + IPI Chemo
100
NIVO + IPI Chemo
(n = 158) (n = 157) (n = 325) (n = 324)
90 90
Median OS, mo 13.7 9.2 Median OS, mo 12.8 10.7
80 (95% CI) (11.2–17.0) (7.7–10.0) 80 (95% CI) (11.3–15.5) (9.4–11.9)
12-mo 12-mo
Overall survival (%)
70 HR (98.6% CI) 0.64 (0.46–0.90) 70 HR (98.2% CI) 0.78 (0.62–0.98)
rate rate
P value 0.0010 P value 0.0110
60 57% 60 53.5%
50 50
40 37% 40
30 30 44% NIVO + IPI
NIVO + IPI
20 20
10 10 Chemo
Chemo
0 0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 0 3 6 9 12 15 18 21 24 27 30 33 36 39
No. at risk Months Months
NIVO + IPI 158 136 116 98 89 63 50 40 31 20 11 9 4 0 325 274 232 191 166 129 97 77 55 33 22 12 6 0
Chemo 157 135 105 72 52 36 21 12 8 4 2 1 1 0 324 281 229 171 131 93 56 41 23 9 5 2 1 0
• Superior OS was observed for NIVO + IPI versus chemo in both patients with tumor cell PD-L1 ≥ 1% and all randomized patients
― Patients with tumor cell PD-L1 ≥ 1%: 36% reduction in the risk of death and a 4.6-month improvement in median OS
― All randomized patients: 22% reduction in the risk of death and a 2.1-month improvement in median OS
aMinimum follow-up 12.9 months. Not for Product Promotional Use 8
Manageable safety profile for both active arms
All treateda
NIVO + chemo NIVO + IPI Chemo
(n = 310) (n = 322) (n = 304)
Patients, n (%) Any grade Grade 3-4 Any grade Grade 3-4 Any grade Grade 3-4
Any TRAEsb 297 (96) 147 (47) 256 (80) 102 (32) 275 (90) 108 (36)
Serious TRAEsb 74 (24) 57 (18) 103 (32) 73 (23) 49 (16) 38 (13)
TRAEs leading to discontinuationb 106 (34) 29 (9) 57 (18) 41 (13) 59 (19) 14 (5)
Treatment-related deathsc 5 (2)d 5 (2)e 4 (1)f
• The most common any-grade TRAEs (≥ 15%) were nausea and decreased appetite in the NIVO + chemo and chemo arms
and rash in the NIVO+ IPI arm
• The incidence of TRAEs in patients with tumor cell PD-L1 ≥ 1% was consistent with all treated patients across all arms
aPatients who received ≥ 1 dose of study drug; bAssessed in all treated patients during treatment and for up to 30 days after the last dose of study treatment; cTreatment-related deaths were reported regardless of
timeframe; dIncluded 1 event each of pneumonia, pneumatosis intestinalis, acute kidney injury, pneumonitis, and pneumonitis/ respiratory tract infection; eIncluded 2 events of pneumonitis and 1 event each of interstitial
lung disease, acute respiratory distress syndrome, and pulmonary embolism; fIncluded 1 event each of septic shock, sepsis, acute kidney injury, and pneumonia.
Not for Product Promotional Use 9Dual I-O continues to demonstrate durable long-term
survival for 6+ years in metastatic melanoma
Melanoma: CM -067 (6.5 yr update)
100
NIVO + IPI (n = 314) NIVO (n = 316) IPI (n = 315)
• Nearly half of patients
90
Median (95% CI), mo 72.1 (38.2–NR) 36.9 (28.2–58.7) 19.9 (16.8–24.6) alive after 6+ years
HR (95% CI) vs IPI 0.52 (0.43–0.64) 0.63 (0.52–0.76) –
80
70
HR (95% CI) vs NIVOa 0.84 (0.67–1.04) – –
• Represents longest follow-
60
up for a dual I-O trial at
52% 49%
50%
6.5 years
OS (%)
50
40
44% 43% 42%
• Durability of dual I-O is
30 demonstrated by
20 NIVO + IPI 26%
23% 23%
consistent shape of the OS
curve
NIVO
10
IPI
0
0 3 6 9 12 15 18 21 24 27 30 33 36 39 42 45 48 51 54 57 60 63 66 69 72 75 78 81 84 87
Months
Not for Product Promotional Use 10Differentiated profile for dual I-O in 1L lung cancer
CM -227 (4 yr update) CM –9LA (2 yr update)
PD-L1>1%
OS in all randomized patients
40%
36%
33%
• Longest follow-up for a dual I-O trial in NSCLC • Earlier data addressed early part of curve
• OS curve is flat with a distinct tail • Data continues to mature & show durability
• Proven durability demonstrated • At 2 years: OS for CM-9LA was durable vs chemo, with
38% alive vs 26%; CM-227 OS was 40%
Not for Product Promotional Use
Not for Product Promotional Use 11Next novel I-O Combination: Relatlimab + Nivo
• LAG-3 and PD-1 are distinct
NIVO PD-L1/2 APC
immune checkpoints, often co-
expressed on tumor-infiltrating PD-1
LAG-3 PD-1 MHC I
lymphocytes, and contribute to TCR MHC II
tumor-mediated T-cell Exhausted
+ RELA Activated
exhaustion1,2 T cell + NIVO
T cell
LAG-3 RELA
• In preclinical models,
LAG-3 and PD-1 blockade Tumor cell
demonstrated synergistic NIVO death
antitumor activity1 Tumor
cell
APC, antigen-presenting cell; MHC, major histocompatibility complex; TCR, T-cell receptor.
1. Woo S-R, et al. Cancer Res 2012;72:917–927; 2. Anderson AC, et al. Immunity 2016;44:989–1004;
Not for Product Promotional Use 12RELATIVITY-047:
Global, randomized, double-blind, Phase 2/3 studya
Key eligibility criteria N = 714
• Previously untreated
unresectable or
RELA 160 mg + NIVO 480 mg Primary endpoint
metastatic melanomaa
fixed-dose combination (FDC) IV Q4W • PFS by BICRd
• ECOG PS 0–1 R
1:1
Stratification factors
Secondary endpoints
• LAG-3b • OS
NIVO 480 mg IV Q4W
• PD-L1c • ORR by BICRd
• BRAF
• AJCC v8 M stage
AJCC, American Joint Committee on Cancer; BICR, blinded independent central review; CTLA-4, cytotoxic T lymphocyte antigen-4; ECOG PS, Eastern Cooperative Oncology Group
performance status; IHC, immunohistochemistry; IV, intravenous; ORR, overall response rate; Q4W, every 4 weeks; R, randomization.
ClinicalTrials.gov: NCT03470922; Lipson E, et al. Poster presentation at ESMO Congress; October 19–23, 2018; Munich, Germany. Abstract 1302TiP.
aPrior adjuvant/neoadjuvant treatment permitted (anti-PD-1 or anti-CTLA-4 permitted if at least 6 months between the last dose and recurrence; interferon therapy permitted if the last dose
was at least 6 weeks before randomization); bLAG-3 expression on immune cells was determined using an analytically validated IHC assay (LabCorp); cPD-L1 expression on tumor cells was
determined using the validated Agilent/Dako PD-L1 IHC 28-8 pharmDx test; dFirst tumor assessment (RECIST v1.1) performed 12 weeks after randomization, every 8 weeks up to 52 weeks,
and then every 12 weeks. Database lock date: March 9, 2021.
Not for Product Promotional Use 13Rela + Nivo FDC demonstrated significantly longer PFS
RELA + NIVO FDC demonstrated significantly longer PFS by BICR vs NIVO
RELA + NIVO NIVO
(n = 355) (n = 359)
100
Median PFS, months 10.12 4.63
(95% CI) (6.37–15.74) (3.38–5.62)
80 HR (95% CI) 0.75 (0.62–0.92)
P value 0.0055
60
PFS (%)
47.7% (95% CI: 41.8–53.2)
40 RELA + NIVO
36.0% (95% CI: 30.5–41.6) NIVO
20
0
0 3 6 9 12 15 18 21 24 27 30
No. at risk Months
RELA + NIVO 355 201 163 132 99 81 75 67 30 6
NIVO 359 174 124 94 72 61 57 49 27 6
CI, confidence interval; HR, hazard ratio.
All randomized patients. Statistical model for HR and P value: stratified Cox proportional hazard model and stratified log-rank test. Stratified by LAG-3 (≥ 1% vs < 1%), BRAF Not for Product Promotional Use 14
(mutation positive vs mutation wild-type), AJCC M stage (M0/M1any[0] vs M1any[1]). PD-L1 was removed from stratification because it led to subgroups with < 10 patients.PFS demonstrated across subgroups & stratification factors
RELA + NIVO NIVO
Subgroup Events/no. of patients Unstratified HR for progression or death (95% CI)
Overall 180 (355) 211 (359) 0.76 (0.62–0.92)
Age categorization, years ≥ 18 and < 65 99 (187) 117 (196) 0.83 (0.64–1.09)
≥ 65 and < 75 50 (102) 60 (103) 0.69 (0.47–1.00)
≥ 65 81 (168) 94 (163) 0.69 (0.51–0.93)
≥ 75 31 (66) 34 (60) 0.69 (0.42–1.13)
Sex Male 98 (210) 123 (206) 0.68 (0.52–0.89)
Female 82 (145) 88 (153) 0.88 (0.65–1.19)
LDH ≤ ULN 100 (224) 127 (231) 0.70 (0.54–0.91)
> ULN 79 (130) 84 (128) 0.80 (0.59–1.09)
≤ 2 × ULN 158 (322) 186 (328) 0.75 (0.60–0.92)
> 2 × ULN 21 (32) 25 (31) 0.75 (0.42–1.35)
ECOG PS 0 108 (236) 136 (242) 0.74 (0.57–0.95)
1 72 (119) 75 (117) 0.78 (0.56–1.07)
Tumor burden per BICR < Q1 26 (74) 37 (83) 0.62 (0.37-1.03)
Q1 toFavorable profile with no unexpected safety signals
RELA + NIVO (n = 355) NIVO (n = 359)
AE, n (%) Any grade Grade 3–4 Any grade Grade 3–4
Any AE 345 (97.2) 143 (40.3) 339 (94.4) 120 (33.4)
TRAE 288 (81.1) 67 (18.9) 251 (69.9) 35 (9.7)
Leading to discontinuation 52 (14.6) 30 (8.5) 24 (6.7) 11 (3.1)
TRAE ≥ 10%
Pruritus 83 (23.4) 0 57 (15.9) 2 (0.6)
Fatigue 82 (23.1) 4 (1.1) 46 (12.8) 1 (0.3)
Rash 55 (15.5) 3 (0.8) 43 (12.0) 2 (0.6)
Arthralgia 51 (14.4) 3 (0.8) 26 (7.2) 1 (0.3)
Hypothyroidism 51 (14.4) 0 43 (12.0) 0
Diarrhea 48 (13.5) 3 (0.8) 33 (9.2) 2 (0.6)
Vitiligo 37 (10.4) 0 35 (9.7) 0
Potential to bring I-O combination treatment to more patients
TRAE, treatment-related adverse event. aHemophagocytic lymphohistiocytosis, acute odema of the lung, and pneumonitis; bSepsis and Not for Product Promotional Use 16
myocarditis, worsening pneumonia event. Includes events reported between first dose and 30 days after last dose of study therapy.Future expansion opportunities for relatlimab
Early stage Hepatocellular Non-small cell lung
melanoma carcinoma (post TKI) cancer (1L NSCLC)
• Initiating new Ph3 study in • Initiated Phase 2* • Initiated Phase 2*
adjuvant melanoma — Rela+Nivo — Rela+Nivo+Chemo vs
• Potential to help additional Nivo+Chemo
• Expanding POC in HCC to
melanoma patients, earlier inform registrational program • Opportunity to expedite
in their disease development into
registrational studies
*based on data from single arm Ph1 basket/umbrella study Not for Product Promotional Use 17Broad program with several recent successes,
crossing tumors and stages of disease
Metastatic Setting Early-Stage Setting
Tumor/Trial Status Tumor/Trial Status Tumor/Trial Status Tumor/Trial Status
1L NSCLC Approved √ 1L Gastric Approved √ Esophageal (Adj) Approved √ HCC (Adj) 2023+
CM-9LA CM-649 (O+chemo) CM-577 CM-9DX Read-out
Opdivo + Chemo Opdivo + Yervoy, Opdivo vs Placebo Opdivo vs Placebo
vs Chemo Opdivo + Chemo,
vs Chemo
1L RCC Approved √ 1L Mesothelioma Approved √ MIBC (Adj) PDUFA NSCLC (Adj) 2023+
CM-9ER CM-743 CM-274 Sep 3, 2021 ANVIL Read-out
Opdivo + Cabo Opdivo + Yervoy Opdivo vs Placebo Opdivo
vs Sutent vs Chemo vs Observation
1L Melanoma ASCO 2021 √ 1L Melanoma 2022 NSCLC (Neo-Adj) 2020 pCR √ NSCLC Stage 3 2023+
CA224-047 CA045-001 Read-out CM-816 (Unresectable) Read-out
Relatlimab + Opdivo Opdivo + bempeg Opdivo + Chemo CM-73L
vs Opdivo vs Opdivo vs Chemo 2023+ EFS Opdivo mono, Opdivo
+ Yervoy vs Infinzi
1L Esophageal ASCO 2021 √ 1L HCC 2023+ Renal (Adj) 2022/2023 NSCLC (Peri-Adj) 2023+
CM-648 CM-9DW Read-out CM-914 Read-out CM-77T Read-out
Opdivo+Yervoy Opdivo + Yervoy vs Opdivo + Yervoy (Part A) Neo-adj Opdivo +
vs Chemo; Sorafenib/lenvatinib vs Placebo Chemo followed by
Opdivo + Chemo Adj Opdivo
vs Chemo vs Chemo
1L Bladder 2021 Prostate (mCRPC) 2022 MIBC (Peri-Adj) 2023+
CM-901 Read-out CM-7DX Read-out CA017-078 Read-out
Opdivo + Yervoy + (PD-L1+) Opdivo + Chemo Opdivo + Chemo,
Chemo vs Chemo vs Placebo + Chemo Opdivo + IDO + Chemo,
vs Chemo
NotNot
forfor Product
Product Promotional
Promotional UseUse 18
“Approved” = obtained first market approval (U.S.) Readout dates are estimates.ASCO 2021
Chris Boerner
Executive Vice President
Chief Commercialization Officer
Not for Product Promotional UseToday’s successful Oncology franchise provides
foundation for next phase
Successful I-O franchise for 10+ years Next phase driven by
• $8.7B in global net sales in 2020 (Opdivo & Yervoy) Opdivo & Yervoy
• Successfully executed 23 launches across I-O portfolio • Lung (CM-227, CM-9LA)
• Opdivo combinations continue to demonstrate
• Established as a standard of care in 11 tumors durable overall survival
• Maintaining strong position in core tumors despite • Upper GI: Comprehensive offering across 3 new
intense competition current & potential indications (CM-649, CM-577,
CM-648)
• Other expansion opportunities e.g. renal (CM-9ER)
and bladder (CM-274)
Relatlimab
• Next I-O combination; opportunity to expand
leadership in 1L melanoma
• Additional expansion opportunities
Not for Product Promotional Use
Not for Product Promotional Use 20Comprehensive offering across upper GI cancers
EARLY DISEASE ADVANCED DISEASE
CM-648
Predominantly Opdivo + chemo
ATT-3 Establish Opdivo as the upper GI
Approved3
Squamous (ESCC) or O+Y vs. chemo treatment backbone across
CM-577 in 1L ESCC
Approved1 # Patients*
Opdivo mono settings & histologies
vs. chemo in
(US/EU/JP) 2L ESCC
Opdivo mono 4k/7.5k/11k
in adjuvant • CM-577: First & only adjuvant therapy
ESOPHAGEAL
EC & GEJC4 for locally advanced EC/GEJC patients
after trimodal therapy4
Predominantly Adeno # Patients*
(US/EU/JP) CM-649
3k/3k/Novel fixed dose combination of Rela and Nivo delivering a
differentiated option for patients
Compelling I-O/I-O efficacy
Superior efficacy vs PD-1 mono
PFS similar to dual-IO
Manageable safety profile
Side effect profile similar to, & modestly
incremental to, that of PD-1 mono
Unique fixed dose combination
Rela 160mg/Opdivo 480mg Q4W in single infusion
Convenient administration with reduced infusion time
Not for Product Promotional Use 22Opportunity to expand leadership in 1L melanoma
with Rela and Nivo FDC
1L metastatic melanoma market landscape
Approximately 1/3 Approximately 1/3 Approximately 1/3
Opdivo + Yervoy PD-1 monotherapy BRAF MT
Usage driven by deep Patients who are not TKIs used today based
responses & potential candidates for on presence of driver
long-term survival standard dose Yervoy mutation
Potential opportunity Near-term Strong data
pending additional data focus to support usage
Ability to expand usage over time
Not for Product Promotional Use 23Oncology franchise expansion
• Expand presence in key tumors
Continue to grow • Establish GI leadership
Opdivo / Dual I-O
• Novel fixed dose combination
Establish Rela + Nivo • Expand leadership in 1L metastatic
melanoma; multiple expansion
opportunities
• Leveraging differentiated platforms,
Develop additional agents e.g. protein degradation, cell
with novel targets therapy, oral peptides
Not for Product Promotional Use 24Strengthening hematology franchise
Leverage first- / best-in class
CAR T profiles
Further establish & expand new
medicines in Myeloid diseases
• Advance CELMoD agents:
Strengthen/extend leadership Iberdomide & CC-92480
in Multiple Myeloma • Advance BCMA program with
T-cell engager and ADC
Not for Product Promotional Use 25Please standby as we
transition to the Q&A
portion of our
presentation
Not for Product Promotional Use 26Q&A
Chris Boerner, Ph.D.
Executive VP,
Chief Commercialization Officer
Samit Hirawat, M.D.
Executive VP,
Chief Medical Officer,
Global Drug Development
Not for Product Promotional Use 27You can also read
