Optimizing Chemotherapy,
Advancing Survival
39th Annual J.P. Morgan Healthcare Conference
January 13, 2021
Forward-Looking Statements
This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward- looking statements. Forward-looking statements in this presentation include, but are not limited to, those relating to the therapeutic potential of trilaciclib, rintodestrant and lerociclib, the timing of marketing applications in the U.S. for trilaciclib in SCLC, trilaciclib's possibility to improve patient outcomes across multiple indications, rintodestrant's potential to be best-in-class oral SERD, our reliance on partners to develop and commercial licensed products, and the impact of pandemics such as COVID-19 (coronavirus), and are based on the company's expectations and assumptions as of the date of this presentation. Each of these forward-looking statements involves risks and uncertainties. Factors that may cause the company's actual results to differ from those expressed or implied in the forward-looking statements in this presentation are discussed in the company's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein and include, but are not limited to, the company's ability to complete clinical trials for, obtain approvals for and commercialize any of its product candidates; the company's initial success in ongoing clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials; the inherent uncertainties associated with developing new products or technologies and operating as a development- stage company; and market conditions. Trilaciclib, rintodestrant and lerociclib are not approved by the FDA. The safety or effectiveness of trilaciclib, rintodestrant and lerociclib have not been established by the FDA. Except as required by law, the company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
2
Transformed Company Heading into a Pivotal 2021
2020
Trilaciclib
2021
Trilaciclib is a cornerstone therapy:
- Near-termU.S. launch in SCLC (Priority Review)
- Pipeline-in-a-moleculedevelopment opportunity
Partner for
Greater China
Rintodestrant
Lerociclib
CDK2
Discovery Platform
OUT-LICENSED
OUT-LICENSED
Rintodestrant + palbociclib Phase 2 data expected 2Q
$207M cash on hand
(as of December 31, 2020)
Streamlined company focused on maximizing
the development and commercialization of trilaciclib
3
Chemo to Remain Mainstay Therapy Despite Shortcomings
Over 1 million cancer patients receive chemo in the U.S. each year
- Cost-efficientand effective treatment option expected to remain backbone of SoC
- Established high water-mark that has proven difficult to exceed head-to-head
- Immunotherapy with chemo has demonstrated the best results in many tumors
Two Critical Areas of Unmet Need
Proactively reducing the damaging | Meaningfully improving overall | |
consequences of chemotherapy | survival in broad populations | |
High unmet need for new therapies that can significantly reduce myelosuppression
and meaningfully improve efficacy across patient populations
4
Trilaciclib: Novel Approach to Address Shortcomings of Chemo
Trilaciclib
Transient IV CDK4/6 inhibitor
Temporarily blocks progression through the cell cycle
Leads to multiple potential downstream effects
Protects HSPCs and myeloid and lymphoid cell lineages from damage caused by chemotherapy1-3
Neutrophils
T-lymphocytes
Erythrocytes
B-lymphocytes
Platelets
Ability to improve the immune response when
administered with chemotherapy4-9
Enhances T-cell activation
Favorably alters tumor microenvironment
Potential to benefit patients receiving chemotherapy across multiple tumor types
1. Weiss J, et al. Ann Oncol. 2019 Oct; 30(10): 1613-1621. 2. He S, et al. Sci Transl Med. 2017;9:eaal3986. 3. Bisi JE, et al. Mol Cancer Ther. 2016;15:783-93. 4. Tan A, et al. Lancet Oncol. 2019 Sep 28. 5. Zhang J, et al. Nature. 2018;553:91-95. 6. Jerby-Arnon L, et al. Cell. 2018;175:984-997. 7. Goel S, et al. Nature. 2017;548:471-475. 8. Deng J, et al. Cancer Discov. 2018;:216-233. 9.
O'Shaugnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. | 5 |
Trilaciclib Demonstrated Meaningful Benefits Across Studies
Myelopreservation Impact1-5 | Anti-Tumor Efficacy Impact6-11 | |
Protects myeloid
cell lineages
Protects lymphoid
cell lineages
Improves immune
response
Potential to provide myelopreservation and/or anti-tumor efficacy benefits
in patients treated with chemotherapy
1. Weiss J, et al. Ann Oncol. 2019 Oct; 30(10): 1613-1621. 2. He S, et al. Sci Transl Med. 2017;9:eaal3986. 3. Bisi JE, et al. Mol Cancer Ther. 2016;15:783-93. 4. Weiss et al. MASCC Oral Presentation, Abstract #MASCC9-0845. 5. Tan A, et al. Lancet Oncol. 2019 Sep 28. 6. Ferrarotto et al., 2020 North America Conference on Lung Cancer (NACLC), Abstract # OA03.08. 7. Zhang J,
et al. Nature. 2018;553:91-95. 8. Jerby-Arnon L, et al. Cell. 2018;175:984-997. 9. Goel S, et al. Nature. 2017;548:471-475. 10. Deng J, et al. Cancer Discov. 2018;:216-233. 11. O'Shaugnessy et al., | 6 |
2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. | |
Significant Expansion Opportunities for Trilaciclib
Myelopreservation Focus
Anti-Tumor Efficacy Focus
Protecting the bone marrow from the
damaging consequences of
myelotoxic chemo:
- Common SCLC regimens*
- 5-FUbased regimens
- Other myelotoxic regimens
Myelopreservation
Preserving / activating the immune system:
- Alternative to I/O treatment
- Following I/O treatment
- In tumors less responsive to I/O
Improved Survival (single agent)
Improving efficacy of immunotherapy
and chemo combinations:
- With PD-1/PD-L1 inhibitors
- With other immunotherapies
Improved Survival (combinations)
+ Chemo Backbone
* Expected 1Q 2021 U.S. launch in ES-SCLC
Optimizing development plan across three core growth platforms
will enable trilaciclib to benefit as many patients as possible
7
Pipeline-in-a-Molecule Opportunity Beyond ES-SCLC Launch
Key Study Objective:
Myelopreservation
Improved Survival (single agent)
Improved Survival (combinations)
REGISTRATIONAL TRIALS | |||
POTENTIAL | |||
1L / 2L TNBC | |||
APPROVAL / | |||
U.S. LAUNCH | |||
1L CRC | Initiating in | ||
1Q 2021 | |||
1H 2021 | |||
Initiated in | |||
ES-SCLC | |||
2020 | |||
PHASE 2 STUDIES | |||||||||
+ Milestones and | |||||||||
Royalties | |||||||||
Other Tumors | |||||||||
TBD | |||||||||
1L Bladder | |||||||||
Cancer | |||||||||
2L / 3L NSCLC | Initiating in | ||||||||
1H 2021 | |||||||||
Trilaciclib | |||||||||
Neoadjuvant | Initiating in | ||||||||
Breast Cancer | 1H 2021 | Opportunity | |||||||
Initiated in
2020
Aggressively pursuing development in areas of high strategic importance where trilaciclib is most likely to provide meaningful benefits to patients
8
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
- Continue managing investor capital efficiently
Focused on successfully launching trilaciclib in ES-SCLC and
accelerating development into other areas where chemotherapy is used
9
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
- Continue managing investor capital efficiently
10
Prepared for Trilaciclib Approval and U.S. Launch in 1Q21
NDA Discussions on Track
- PDUFA action date for SCLC indication: February 15th, 2021
- NDA under "Priority Review"
- Less complex CMC application given small molecule compound
Pre-Launch Activities Ongoing
- Identified HCP targets
- Profiled key accounts
- Engaged payors
- Educating leading patient advocacy organizations
Ready for 1Q Launch
- G1 infrastructure in place
- Marketing
- Market Access
- Commercial Operations
- Medical Affairs team
- Manufacturing and supply chain
- Boehringer Ingelheim field sales team trained and ready1
- Experienced lung cancer team
- Incentivized structure (% net sales)
Following NDA approval, we are ready to make this important new treatment available
to the majority of patients with ES-SCLC undergoing chemotherapy in the U.S.
1. Three-year agreement where Boehringer Ingelheim leads sales force engagement initiatives for trilaciclib in the U.S. for the initial ES-SCLC indication. The agreement does not extend to additional indications.
11
Opportunity to Meaningfully Impact the Lives of Many Patients
~30k ES-SCLC Patients
Treated Annually in the U.S.1
1L Treated Patients1,2
17.5k
2L Treated Patients1,3
9.5k
3L Treated Patients1,4
2.5k
ES-SCLC patients predominately treated with highly myelosuppressive chemo regimens
- Limited successful innovation given aggressiveness of disease (1L median OS ~1 year5)
- Standard treatment includes 4 to 6 cycles of chemo
Payor research and discussions indicate potential broad patient access to trilaciclib
- Anticipate pricing product above supportive care treatments and below therapeutics
- ~60% of ES-SCLC patients covered by Medicare (expect Medicare to cover label at launch)
Trilaciclib provides a meaningful improvement for SCLC patients and
has potential to generate near-term revenue to further support ongoing development
- Based on incidence of 25k for all SCLC with 81% of patients being diagnosed at Extensive Stage; Decision Resources Group, Small Cell Lung Cancer Disease Landscape & Forecast, March 2020.
- Based on 22k 1L SCLC total patients (20K de novo ES-SCLC and 2K late relapse LS-SCLC) treated at an assumed 80% treatment rate (from 2020 internal primary market research).
- Based on 12.5k 2L SCLC total patients (11k progressed 1L SCLC and 1.5k early relapse LS-SCLC) treated at an assumed 72% treatment rate (from 2020 internal primary market research).
4. Based on 5k 3L SCLC total patients treated at an assumed 50% treatment rate (from 2020 internal primary market research). | 12 |
5. Demonstrated in trilaciclib G1T28-02 and G1T28-05 study control arms. | |
Three Core Goals for a Successful U.S. ES-SCLC Launch
Increase Awareness of Myelosuppression
Communicate the
Unique Benefits of
Trilaciclib
Optimize Early
Experience
Increase awareness of the significant multi-lineage impact of myelosuppression on clinical outcomes, costs, and patients' QoL
Educate prescribers, payers, and patients on the benefits of trilaciclib's proactive multi-lineage protection
Gain inclusion into relevant guidelines / pathways; enable broad patient access; and ensure ease of use for prescribers / nurses / staff
Focused on ensuring patients with ES-SCLC can benefit from trilaciclib
first time and every time they are treated with chemotherapy
13
Prescribers are Enthusiastic to Use Trilaciclib
Prescriber Enthusiasm to Use Trilaciclib for Patients with SCLC Following Education
1L ES-SCLC | 22% | 38% | 17% | 77% |
2L ES-SCLC | 23% | 36% | 18% | 77% |
Extremely Enthusiastic | Very Enthusiastic | Moderately Enthusiastic | |||
Source: internal market research conducted July 2020 (n=153 oncologists)
Education will be key to establish trilaciclib as a Standard of Care
for patients with ES-SCLC receiving chemotherapy
14
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
- Continue managing investor capital efficiently
15
The Burden of Chemotherapy
HEMATOLOGIC EVENT:
CONSEQUENCE:
RESPONSE:
M Y E L O S U P P R E S S I O N
An unavoidable consequence of chemo that impacts patient safety, healthcare system costs and QoL
NEUTROPENIA | ANEMIA | THROMBOCYTOPENIA |
Risk of infection | Fatigue | Risk of bleeding |
G-CSF use | RBC transfusions | Platelet transfusions |
(associated bone pain) | and ESA rescue | |
Increased | Chemotherapy | Hospitalizations |
dose reductions | and unscheduled | |
healthcare costs | ||
and delays | patient care | |
Myelosuppression has a significant negative impact on
clinical outcomes, healthcare costs, and overall patient quality of life
16
Trilaciclib Meaningfully Reduces Myelosuppression in SCLC
Reduced Incidence of Multi-lineage Myelosuppression in 1L‒3L SCLC1
(pooled data across our 3 randomized placebo-controlleddouble-blind trials)
P<0.0001 | |||||||
60% | 53% | P=0.028 | P=0.0067 | ||||
40% | 36% | ||||||
32% | |||||||
20% | P=0.089 | 20% | 20% | ||||
11% | 9% | ||||||
3% | |||||||
0% | |||||||
Severe Neutropenia | Febrile Neutropenia | Grade 3/4 Anemia | Grade 3/4 | ||||
Chemotherapy + Placebo | Chemotherapy + Trilaciclib | Thrombocytopenia | |||||
Clinical Results: Trilaciclib consistently demonstrated meaningful reductions in
hematologic adverse events across multiple randomized SCLC studies
1. Weiss et al., 2020 American Society of Clinical Oncology (ASCO), Abstract #384.
17
Trilaciclib Expected to Drive Significant Payor/Hospital Savings
Average Total Annual Cost Per Patient with a Grade 3/4
Hematologic Event (Jan 2016 - Dec 2019)1
Neutropenia | $131,047 | |
Anemia | $95,954 | |
Thrombocytopenia | $90,053 | |
Average total annual cost per | ||
patient without a grade 3/4 | ||
hematologic event: | $67,802 | |
Cost savings from less hematologic events largely driven by:
- Reduced interventions (e.g., G-CSF, ESA)
- Fewer required transfusions
- Fewer complications and hospitalizations
Payor Impact: Trilaciclib's ability to reduce the severe hematologic consequences of
chemotherapy expected to result in a budget-neutral to savings-positive impact
1. Epstein et al, Journal of Clinical Oncology May 25, 2020; 38, no. 15_suppl
18
Trilaciclib Improves Patients' Quality of Life
89% of cancer patients with myelosuppression rate it as having a moderate to major impact on their life1:
"…the overall fatigue was the worst.
It stole my energy and joy for both life and family. It made me want to quit chemo numerous times."
"I don't feel like doing ANYTHING some days.
It's like depression but completely physical."
"Did not get out as much, not able to work,
always feeling tired."
Trilaciclib helps patient functioning in ES-SCLC patients:
Median Time to Deterioration2
(pooled data from three randomized, placebo-controlled,double-blind trials)
Measure | Placebo | Improvement | |
(months) | (months) | ||
Fatigue | 2.3 | 4.7 | |
Anemia -TOI | 3.8 | 3.4 | |
(Trial Outcome Index) | |||
Functional Well Being | 3.8 | 3.8 | |
Patient Benefit: Trilaciclib's proactive protection enables better quality of life
for patients in this palliative treatment setting
1. Epstein et al, Patient Burden and Real-World Management of Chemotherapy-Induced Myelosuppression: Results from an Online Survey of Patients with Solid Tumors; Advances in Therapy, July 2020
2. Weiss et al., MASCC Oral Presentation 2019, Abstract #MASCC 9-0845 | 19 |
Opportunity for Trilaciclib to Become Standard of Care in SCLC
Clinical Results: Meaningfully reduces the hematologic adverse events in SCLC
Payer Impact: Provides cost savings for system (trilaciclib expected to be budget neutral or better)
Patient Benefits: Improves the overall quality of life for patients
Heightened awareness of myelosuppression due to the COVID pandemic
may further encourage adoption of trilaciclib as a Standard of Care
20
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
- Continue managing investor capital efficiently
21
Aggressively Pursuing Development in Common Tumor Types
300,000
250,000
200,000
150,000
100,000
50,000
0
Patients Receiving Chemo2:
U.S. Incidence and Deaths1
Estimated New Cases
Estimated Deaths
Breast | Lung | Prostate | Colon and Rectal | Melanoma | Bladder | Non-Hodgkin | Kidney Cancer |
(Combined) | Lymphoma | ||||||
110k | 125k | 30k | 115k | <5k | 20k | 45k | <5k |
Shading indicates areas of ongoing or soon to be initiated G1 sponsored studies
G1 has / will soon initiate sponsored studies
in many of the most common and deadly tumor types
- Estimated new cases and deaths from National Cancer Institute for 2020.
- Estimated patients receiving chemotherapy from Kantar Health CancerMPact Patient Metrics, 2019 data based on IQVIA BrandImpact regimen shares and Kantar Health Treatment Architecture
2019 survey data for patients receiving chemo (rounded to nearest 5,000 patients). | 22 |
Broad Portfolio of Impactful Studies Across Tumor Types
Cancer | Indication | Study | Phase 2 | Pivotal | Approval |
Type | Size | ||||
Lung | SCLC | NA | Under Priority Review with FDA | ||
2L / 3L NSCLC | TBD | Starting 1H 2021 | |||
(Post-checkpoint treatment) | |||||
Colorectal | |||||
1L CRC | ~300 | Ongoing | |||
1L TNBC1 | ~170 | Starting 1H 2021 | |||
Breast | 2L TNBC1 | ~80 | Starting 1H 2021 | ||
(Post-checkpoint treatment) | |||||
Neoadjuvant | Adaptive | Ongoing | |||
Bladder | 1L Bladder | TBD | Starting 1H 2021 | ||
(Checkpoint combination) | |||||
Two registrational studies will be ongoing by mid 2021 in addition to multiple Phase 2
studies to evaluate trilaciclib in several treatment settings / tumor types
1. 1L TNBC and 2L TNBC cohorts being conducted under one study protocol.
23
Ongoing First-Line CRC Pivotal Trial
FOLFOXIRI: most efficacious chemo regimen but highly myelosuppressive Ability to significantly expand FOLFOXIRI usage supported by market research
Treatment Phase
P R I M A R Y E N D P O I N T:
Randomization 1:1
Myelopreservation | ||||||
14-day cycles | 14-day cycles | |||||
Induction Phase | Maintenance Phase | |||||
Day 1 | Day 2 | Day 14 | Day 1 | Day 2 | SECONDARY ENDPOINTS: | |
PFS/OS, PRO | ||||||
Cycle X | Cycle X | Cycle X | Cycle X | Cycle X | ||
Placebo + | Placebo | Placebo + | Placebo | TARGET ENROLLMENT: | ||
FOLFOXIRI + | + CI FU | bev + CI FU | + CI FU | |||
bevacizumab | ~300 participants | |||||
Trilaciclib + | Trilaciclib | Trilaciclib | Trilaciclib | PATIENTS TREATED UNTIL | ||
FOLFOXIRI + | + CI FU | + bev + CI FU | + CI FU | |||
bevacizumab | PROGRESSION | |||||
MULTI-DAY CHEMO | ||||||
Maximum of 12 cycles | Until Progression | REGIMEN | ||||
Strong support from preclinical models for the benefits of trilaciclib
in combination with 5-FU-based chemo regimens
24
Metastatic TNBC is an Area of High Unmet Need
Breast Cancer Subtypes
HER2 + | |
TNBC | |
HR + | (15% - 20%) |
- TNBC tumors categorized by lack of HR expression and HER2 gene amplification
- Tumors are aggressive and difficult to treat
- Targeted therapies only demonstrated benefit in subpopulations (e.g., PD-L1 agents, PARPs)
- Antibody Drug Conjugates (ADCs) demonstrated OS improvement in 3L to date, but have associated toxicity
Urgent need for new therapies that extend Overall Survival with decreased toxicity
25
Observed Robust OS Improvement in mTNBC Phase 2
Overall Survival in Intent-to-Treat Population1
Treatment Group2 | Median OS, | Hazard Ratio | P Value | |||
Group 2 (trila + gem/carbo) | 2 | months | (95% CI) | |||
Group 1: | 12.6 | - | - | |||
Group 3 (trila + gem/carbo)2 | (gem/carbo) | |||||
Group 2: | Not Reached | 0.31 | 0.0016 | |
(gem/carbo + trilaciclib) | (0.15-0.63) | |||
Group 1 (gem/carbo)2 | ||||
Group 3: | 17.8 | 0.40 | 0.0004 | |
(gem/carbo + trilaciclib) | (0.22-0.74) | |||
Observed a robust statistically significant improvement in Overall Survival
for both trilaciclib schedules
- O'Shaughnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. Note: primary endpoints relating to reduction in severe neutropenia not achieved in this study.
- Patients randomized to receive gem/carbo chemotherapy only (Group 1) or gem/carbo plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2)
or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). | 26 |
OS Improvement Regardless of PD-L1 Status
Overall Survival for PD-L1 Positive Tumors1
Median OS | Hazard Ratio | |||
Treatment Group2 | Patients | (95% CI), | P Value | |
(95% CI) | ||||
Months | ||||
Group 1: | 17 | 10.5 | - | - |
(gem/carbo) | (6.3 - 18.8) | |||
Group 2 and 3: | 32 | 32.7 | 0.34 | 0.004 |
(gem/carbo + trilaciclib) | (17.7 - NR) | (0.2 - 0.7) | ||
Overall Survival for PD-L1 Negative Tumors1
Median OS | Hazard Ratio | ||||
Treatment Group2 | Patients | (95% CI), | P Value | ||
(95% CI) | |||||
Months | |||||
Group 1: | 10 | 13.9 | - | - | |
(gem/carbo) | (12.6 - NR) | ||||
Group 2 and 3: | 26 | 17.8 | 0.48 | 0.093 | |
(gem/carbo + trilaciclib) | (13.1 - NR) | (0.2 - 1.2) | |||
Overall Survival improvement was observed regardless of tumor PD-L1 status
(greater effect in PD-L1 positive tumors)
- O'Shaughnessy et al., 2020 San Antonio Breast Cancer Symposium (SABCS), Poster #PD1-06. Note: primary endpoints relating to reduction in severe neutropenia not achieved in this study.
- Patients randomized to receive gem/carbo chemotherapy only (Group 1) or gem/carbo plus one of two dosing schedules of trilaciclib: trilaciclib administered on the day of chemotherapy (Group 2)
or trilaciclib administered the day prior to and the day of chemotherapy (Group 3). | 27 |
Initiating TNBC Pivotal Trial (1L and 2L Cohorts) in 1H 2021
Strong evidence of efficacy across subsets and line of treatment in Phase 2 trial
Evaluating 1L checkpoint-naïve and 2L checkpoint-experienced patients
P R I M A R Y E N D P O I N T: | ||||
Cohort 1: | 1:1 | GC on Days 1 and 8 every 21 days until | Overall survival | |
1L TNBC | SECONDARY ENDPOINTS: | |||
Randomization | progression | |||
(checkpoint naive) | PRO, myelopreservation | |||
Cohort 2: | trilaciclib + GC on Days 1 and 8 every 21 | measures, PFS/ORR | ||
2L TNBC | TARGET ENROLLMENT: | |||
days until progression | ||||
(post-checkpoint) | ~170 1L and ~80 2L | |||
participants |
Pivotal study evaluating trilaciclib in mTNBC (PD-L1 positive and negative patients)
complements ongoing I-SPY 2 Phase 2 Neoadjuvant BC study
28
Initiating Two Additional Trilaciclib Phase 2 Trials in 1H 2021
1L Bladder Study (anti-PD-L1 combination)
Strong rationale for trilaciclib + chemo + I/O in 1L bladder cancer
- Known immunogenic tumor responsive to chemo + I/O
- Data suggests synergistic effect of trilaciclib + checkpoint1-3
- Similar chemo as TNBC study (gemcitabine/platinum)
- Benefits of treating patients until progression
Interim data expected in late 2022
- Primary aim to evaluate anti-tumor efficacy
- Randomized open-label study design
2L / 3L NSCLC Study (post-checkpoint)
Important area to demonstrate benefits of trilaciclib in post-checkpoint setting
- Known immunogenic tumor
- Trilaciclib mechanism is distinct from checkpoints
- High unmet need as treatment options limited in 2L / 3L
- Complementary commercial fit with SCLC indication
Interim data expected in early 2023
- Primary aim to evaluate anti-tumor efficacy
- Randomized double-blind study
Important future expansion areas for trilaciclib with data available in next 2 - 3 years
- Lai et al., Journal for ImmunoTherapy of Cancer 2020; 8:e000847. doi:10.1136/jitc-2020-000847.
- Deng et al., Cancer Discov. 2018;8(2):216- 33.
3. Daniel et al., 2019 European Society for Medical Oncology (ESMO), Abstract # 1742PD | 29 |
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
- Continue managing investor capital efficiently
30
Rintodestrant Demonstrates a Favorable Oral SERD* Profile
Fulvestrant is currently only SERD available
- Proven approach but painful intramuscular injections limit use to 2L and preclude use in earlier lines of therapy
- An oral SERD has potential to move into earlier lines of ER- positive breast cancer therapy
Rintodestrant monotherapy Phase 1b findings to date:
- Favorable tolerability - AEs mostly Grade 1 or Grade 2
- Strong ER target engagement/occupancy with evidence of anti-tumor activity in heavily pre-treated patients
40-patient Phase 2 combination trial with CDK4/6 inhibitor palbociclib ongoing; data in 2Q21
Phase 2 combination data will be important to help secure partner to fund Phase 3 investment
* SERD = Selective Estrogen Receptor Degrader
Next steps will be evaluated following data readout expected in 2Q21
31
2021 Key Objectives
- Obtain U.S. approval for ES-SCLC and successfully launch trilaciclib in 1Q
- Establish trilaciclib as Standard of Care for ES-SCLC patients in the U.S.
- Maximize long-term value of trilaciclib by executing robust development plan
- Evaluate partnership options for rintodestrant following combination data readout in 2Q
32
Continue to Efficiently Manage Capital
- ~$207M cash at year-end 2020 provides runway into second half of 2022
- Efficiently executing plan with lean organization of ~125 FTEs
- Utilizing capital efficient promotion arrangement with Boehringer Ingelheim for trilaciclib U.S. launch in SCLC
- Expect to leverage co-development opportunities with partner Simcere for potential cost and timing efficiencies
- Access to debt facility up to $100M total ($20M drawn to date)
- Potential future milestones (up to $486M) and royalties from licensing agreements
Efficiently managing capital with a lean organization and benefiting from existing partnership arrangements
33
Maximizing Value of Trilaciclib
Key Study Objective:
Myelopreservation
Improved Survival (single agent)
Improved Survival (combinations)
REGISTRATIONAL TRIALS | |||
POTENTIAL | 1L / 2L TNBC | ||
Data Readout: | |||
U.S. APPROVAL | 1L CRC | ||
2H 2023 | |||
Data Readout: | |
ES-SCLC | |
1H 2023 | |
Launch: | |
1Q 2021 |
PHASE 2 STUDIES | |||||||||
+ Milestones and | |||||||||
Royalties | |||||||||
Other Tumors | |||||||||
TBD | |||||||||
1L Bladder | |||||||||
Cancer | |||||||||
2L / 3L NSCLC | Data Readout: | ||||||||
2H 2022 | |||||||||
Trilaciclib | |||||||||
Neoadjuvant | Data Readout: | ||||||||
Breast Cancer | 1H 2023 | Opportunity | |||||||
Data Readout:
2H 2023
Expect ES-SCLC launch in 1Q 2021 and multiple data readouts
to drive expansion and long-term growth
34
Attachments
- Original document
- Permalink
Disclaimer
G1 Therapeutics Inc. published this content on 13 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 13 January 2021 20:01:09 UTC