On February 14, 2022 FibroGen, Inc. (NASDAQ: FGEN) reported that it will announce its fourth quarter and full year 2021 financial results on Monday, February 28 after the market close (Press release, FibroGen, FEB 14, 2022, View Source [SID1234608079]). FibroGen will also conduct a conference call on that day at 5:00 p.m. ET (2:00 p.m. PT) with the investment community to further detail the company’s corporate and financial performance.

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Conference Call and Audio Webcast
Interested parties may access a live audio webcast of the conference call via the FibroGen website at View Source It is recommended that listeners access the website 15 minutes prior to the start of the call to download and install any necessary audio software.

A replay of the webcast and investor presentation will be available shortly after the call for a period of 7 days. To access the replay, please dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and use passcode 1795663.

On February 14, 2022 Bio-Techne Corporation (NASDAQ:TECH) reported an important publication in World Journal of Urology, entitled Pre–diagnosis urine exosomal RNA (ExoDx EPI score) is associated with post–prostatectomy pathology outcome (Press release, Bio-Techne, FEB 14, 2022, https://investors.bio-techne.com/news/detail/292/bio-techne-announces-publication-of-new-data-demonstrating-exodx-prostate-test-correlation-with-post-prostatectomy-pathology-outcomes [SID1234608078]). Principal investigator Dr. Alexander Kretschmer, urologist from Ludwig Maximilian University of Munich, Germany, and colleagues demonstrated utility of the ExoDx Prostate test, or EPI, to address limitations related to prostate biopsy sampling error, prostate biopsy bias as well as multifocality of the disease, providing a more relevant assessment of low-risk men who could remain on active surveillance. The significance of this study is that in men with an EPI score below the cut-point of 15.6, the ExoDx Prostate test could prevent low-risk men from proceeding to radical prostatectomy.

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According to the American Cancer Society, active surveillance is often used to monitor prostate cancer closely. Usually this includes a doctor visit with a prostate-specific antigen (PSA) blood test about every 6 months and a digital rectal exam at least once a year. Prostate biopsies and imaging tests may be done every 1 to 3 years. If test results change, the doctor would then discuss treatment options. Active surveillance is less invasive and a preferable option for men versus radical prostatectomy surgery that entails removal of the entire prostate gland and surrounding lymph nodes.

The study consisted of 2,066 subjects and explored the applicability of an exosome-based, non-invasive urine test for men with low-risk disease considering active surveillance. When EPI scores were evaluated for men with grade group 1 (GG1) on biopsy, those men who were upgraded to grade group 3 (≥GG3), had significantly higher scores compared to men that remained GG1 post radical prostatectomy. In contrast, neither PSA nor any of the standard multiparametric risk calculators provided any discrimination between these groups. Further, in this cohort, zero cases were upgraded to ≥GG3 when the EPI scores were below the cut-point of 15.6 resulting in a high NPV (100%) for ruling out ≥GG3.

The EPI test was previously validated in patients presenting for an initial biopsy as well as men with a prior negative biopsy. This study confirms that the ExoDx Prostate test also performs exceptionally well to predict which men will not be upgraded ≥GG3 at subsequent radical prostatectomy.

Prostate cancer (PCa) is a leading cause of cancer death among men in the United States, with more than 3.6 million men living with prostate cancer. It is estimated that more than 248,000 newly diagnosed cases occurred in 2021. A large percentage of newly diagnosed prostate cancers are indolent, clinically insignificant, and with low metastatic potential. These cancers typically do not require definitive treatment and may be managed most effectively with active surveillance. The low specificity of PSA which contributes to the high frequency of newly-diagnosed low-risk PCa suggests that 60–70% of men may be able to avoid biopsy.

Dr. Alexander Kretschmer, urologist from Ludwig Maximilian University of Munich, Munich, Germany, stated, "From the clinical perspective, active surveillance (AS) is still underused in eligible patients with low-risk localized prostate cancer and more tools are necessary to inform AS decisions. This study demonstrated the EPI test accurately identified men with GG1 at biopsy who remained GG1 post-radical prostatectomy (RP) compared to men upgraded to ≥ GG3 post-RP (p < 0.001). Since the EPI test was associated with low-risk pathology post-RP, and can be a valuable tool for urologists informing AS decisions."

"This study has important implications for up to 75% of men who would be eligible for an active surveillance program and potentially avoid radical prostatectomy," commented Chuck Kummeth, President and Chief Executive Officer of Bio-Techne Corporation. "Using ExoDx Prostate to predict which men can undergo active surveillance is an exciting and substantial advancement for men with a diagnosis of low-grade prostate cancer. The ExoDx Prostate Test provides the right intervention, for the right patient, at the right time."

On February 14, 2022 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported the presentation of new data showing that bavdegalutamide (also known as ARV-110), a novel PROTAC protein degrader targeting the androgen receptor (AR), continues to provide evidence of anti-tumor activity and patient benefit in metastatic castration-resistant prostate cancer (mCRPC) (Press release, Arvinas, FEB 14, 2022, View Source [SID1234608077]). These data show that bavdegalutamide reduced prostate-specific antigen (PSA) levels greater than or equal to 50% (PSA50) in 46% of patients with tumors harboring AR T878X/H875Y (T878X = T878A or T878S) mutations. Updated Phase 1 and interim Phase 2 ARDENT data will be presented in both a rapid abstract session and a poster session on February 17, 2022, at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium.

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"These results are very encouraging and reinforce our conviction that bavdegalutamide has the potential to provide meaningful clinical benefit to patients with mCRPC who have progressed after treatment with novel hormonal agents and for whom few treatment options exist," said John Houston, Ph.D., president and chief executive officer of Arvinas. "With particularly robust activity in a molecularly defined patient population, we believe there is a clear path forward to developing this novel treatment as a precision medicine and plan to initiate a pivotal trial by year end 2022."

Highlights from the bavdegalutamide abstract (data cut-off date August 26, 2021):

Across 140 biomarker-evaluable patients with ≥1 month of PSA follow-up in the completed Phase 1 dose escalation and ongoing Phase 2 ARDENT expansion cohort:

Evidence of anti-tumor activity and patient benefit, including:
PSA50 rate of 46% in patients with AR T878X/H875Y tumor mutations (n=26)
Two confirmed RECIST (Response Evaluation Criteria in Solid Tumors) partial responses out of seven RECIST-evaluable patients with AR T878X/H875Y tumor mutations
PSA50 rate of 26% (five of 19) in evaluable patients in the subgroup defined as "less pretreated" (having received only one prior novel hormonal agent and no prior chemotherapy). The "less pretreated" subgroup had a similar circulating tumor DNA molecular profile to the more pretreated, biomarker-defined subgroups in the ARDENT trial; a majority of patients with PSA50 declines in this group had tumors with the AR T878X/H875Y mutations
Bavdegalutamide had a manageable tolerability profile at the recommended Phase 2 dose (RP2D) of 420 mg. The majority of treatment-related adverse events (TRAEs) were Grade 1/2 and there were no Grade ≥4 TRAEs in the 113 patients treated at the RP2D.
The most common TRAEs of any grade at the RP2D across Phase 1 and the ongoing phase 2 ARDENT expansion cohort were nausea (Grade 1/2: 42%; Grade 3: 1%), fatigue (Grade 1/2: 27%; Grade 3: 1%), vomiting (Grade 1/2: 23%; Grade 3: 1%), decreased appetite (Grade 1/2: 19%; Grade 3: 0), diarrhea (Grade 1/2: 15%; Grade 3: 2%), and alopecia (Grade 1/2: 11%).
"Novel hormonal agents have become standard of care in castration-sensitive prostate cancer and there is a need for novel AR therapies with the potential to provide benefit for patients with mCRPC and tumors that have developed resistance," said Ron Peck, M.D., chief medical officer at Arvinas. "As an oncologist, I’m particularly excited by a precision medicine approach with the potential to identify patients who are most likely to respond to bavdegalutamide."

Additional data from the completed Phase 1 and interim results from the ongoing Phase 2 ARDENT trial will be presented on Thursday, February 17, 2022. The cut-off date for data in the rapid abstract session and the poster session was December 20, 2021.

Poster presentation:

Poster Title: Phase 1/2 study of ARV-110, an androgen receptor (AR) PROTAC degrader, in metastatic castration-resistant prostate cancer (mCRPC)
Session: Poster Session A: Prostate Cancer
Date: Thursday, February 17, 2022
Time: 2:30 – 4:00 p.m. ET
Rapid abstract session (7:45 – 8:45 p.m. ET):

Rapid Abstract Title: Rapid Abstract Session A: Prostate Cancer
Date: Thursday, February 17, 2022
Time: 7:55 – 8:00 p.m. ET
The full abstract can be found at the official ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium website here.

Arvinas Webcast Investor Meeting
Arvinas will host a conference call and webcast Thursday, February 17, 2022, at 8:30 a.m. ET, to discuss the completed Phase 1 dose escalation data and interim data from the Phase 2 ARDENT trial presented at ASCO (Free ASCO Whitepaper) GU. Participants are invited to listen by dialing (844) 467-7654 (domestic) or (602) 563-8497 (international) five minutes prior to the start of the call and providing the passcode 1085203.

Supporting materials for the conference call and webcast will be available on the Arvinas’ website at www.arvinas.com under Events + Presentations. A replay of the webcast will be archived on the Arvinas website following the presentation.

About Bavdegalutamide (ARV-110)

Bavdegalutamide is an investigational orally bioavailable PROTAC protein degrader designed to selectively target and degrade the androgen receptor (AR). Bavdegalutamide is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer.

Bavdegalutamide has demonstrated activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies.

On February 14, 2022 ImmunityBio, Inc. (NASDAQ: IBRX), a clinical-stage immunotherapy company, reported positive data from the company’s late-stage bladder cancer trial (QUILT-3.032) (Press release, ImmunityBio, FEB 14, 2022, View Source [SID1234608075]). The data showed sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ (NMIBC CIS) bladder cancer (Cohort A) and with papillary disease (Cohort B). Of the 83 patients with BCG-unresponsive NMIBC CIS, 59 (71%) had a complete response with a median duration of response of 24.1 months—exceeding historical complete response rates of 41% and 18% for FDA-approved therapies pembrolizumab and valrubicin, respectively. In the papillary disease arm of the study (Cohort B), 57% of patients are disease free at 12 months and 53% at 18 months.

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"We are excited with these promising results," said Sam Chang, M.D., Urologic Surgery Chief Surgical Officer, Vanderbilt Ingram Cancer Center and trial investigator. "This study suggests that BCG induces trained immunity as the prime, while N-803 serves as a vital boost for innate immune memory. These results of high efficacy activity and excellent safety profile set a new bar for NMIBC treatment, and together with the familiar and favorable mode of administration, will advance our current standards of care for patients with bladder cancer."

The latest data from this trial exceeds AUA-FDA workshop benchmarks for both the magnitude of complete remission and the duration of complete response for new therapies for BCG-unresponsive bladder cancer. Indeed, the benchmark of 30% durable response at 18 to 24 months for a clinically meaningful therapy "is likely too high and may not be realistically achievable,"3 according to recommendations published in the Journal of Clinical Oncology. This "realistically unachievable" endpoint of 30% durable response at 18 months has in fact now been achieved and exceeded with the combination of Anktiva and BCG in this trial reported today. Taken together, the high rates of complete response, cystectomy avoidance, avoidance of progression to muscle invasive disease in the patients that responded, and the prolonged duration of complete response, as well as the favorable safety profile, places this novel immunotherapy combination at the forefront of both existing approved and potential treatments for bladder cancer patients.

"Trained immunity is a recently discovered immune system response triggered by BCG. Natural Killer (NK) and T cells are activated by BCG resulting in bladder cancer cell death. When an appropriate secondary stimulus is administered along with BCG, that trained immune response is enhanced to induce immune memory resulting in a prolonged duration of immunological response," said Patrick Soon-Shiong, M.D., Executive Chairman and Global Chief Scientific and Medical Officer of ImmunityBio. "N-803, our IL-15 superagonist which proliferates NK and T cells, serves as this enhancing secondary boost and augments the immunological response when given in combination with BCG. This mechanism of action of inducing trained innate immune memory, through the combination of N-803 and BCG, accounts for the prolonged 24-month durable complete response reported in this trial."

"These results support our hypothesis that immunogenic cell death can induce long-term memory and that N-803 increases the immunologic potential of BCG, even in patients who become unresponsive to BCG alone," Soon-Shiong said. "N-803 does this by stimulating proliferation and enhancing activity of tumor-killing Natural Killer (NK) cells and T cells, acting as a secondary stimulus or boost to the prime trained immunity induced by BCG."

The study results presented at ASCO (Free ASCO Whitepaper) GU are summarized below:

Cohort A (CIS)
Excellent safety and tolerability profile of N-803 + BCG for CIS

0% treatment-related SAEs
0% immune-related AE
0% grade 4 and 5 AE
71% Complete remission (CR) rate at anytime
24.1 Months median durable complete remission
96% Avoidance of bladder cancer progression at 24 months in responders
91% Avoidance of cystectomy at 24 months in responders
100% Bladder cancer specific overall survival at 24 months
Favorable & familiar dosing schedule with activity localized to the bladder
Cohort B (Papillary Disease)
Excellent safety and tolerability profile of N-803 + BCG for papillary disease

0% treatment-related SAEs
0% immune-related AE
0% grade 4 and 5 AE
57% Disease free survival rate at 12 months
99% Overall bladder cancer specific survival
95% Cystectomy avoidance rate
Favorable & familiar dosing schedule with activity localized to the bladder
"When we began the QUILT trials across multiple tumor types, initiating our Cancer Moonshot program, the goal was to achieve a new paradigm in cancer care by activating the patient’s own immune system to induce NK and T cell memory with long-term complete remission in patients who have failed all current therapies," Soon-Shiong said. "With these results in bladder cancer, as well as our recently reported results in pancreatic cancer, we are one step closer to proving our hypothesis that delivering therapies that harness the patient’s own immune system is what will truly transform current standards of care."

The data will be announced on Friday, February 18 during an oral presentation at the 2022 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium titled Phase II/III clinical results of IL-15RαFc superagonist N-803 with BCG in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC)

Incidence of Bladder Cancer

Bladder cancer has a high incidence worldwide; in 2020, an estimated 573,278 new cases were diagnosed and caused 212,536 deaths.4 In the United States, bladder cancer is the fourth most commonly-diagnosed solid malignancy in men and the twelfth for women; the American Cancer Society estimates there will be 83,730 new cases and 17,200 deaths from bladder cancer in 2021.5 Approximately 75–85% of bladder cancer patients present with a disease confined to the mucosa (stage Ta, carcinoma in situ) or submucosa (stage T1); these categories are grouped as non-muscle-invasive bladder cancer (NMIBC). Of these, approximately 70% present as stage Ta, 20% as T1, and 10% as CIS.6

For the last 30 years, BCG immunotherapy has been the standard for treating NMIBC. However, disease recurrence and progression rates remain unacceptably high. Standard-of-care recommendations include lifetime invasive surveillance and rapid treatment of recurrences, creating a substantial financial burden and drastic impact on quality of life. Of those patients who experience recurrence, approximately 30% will succumb to their disease over a 15-year period, and another 50% will undergo radical cystectomy of the bladder (surgical removal of the bladder that may require removing surrounding organs) in an attempt to control the disease.7

There is an urgent, unmet need to treat NMIBC and avoid cystectomy. Despite the advent of minimally-invasive procedures and robotic techniques, the 90-day mortality and morbidity rates in cystectomy patients remain unacceptably high at 3-6% and 28-64%, respectively.8&9 Based on this urgent need, the FDA published guidance in February 2018 to address BCG unresponsive NMIBC, stating that the goal of therapy in patients with BCG-unresponsive NMIBC is to avoid cystectomy.

About the Study and Breakthrough Designation

QUILT 3.032 is an open-label, three cohort, multicenter Phase 2/3 study of intravesical BCG plus Anktiva (N-803) in patients with BCG-unresponsive high-grade NMIBC (NCT03022825) and was opened in 2017. The primary endpoint for Cohort A of this Phase 2/3 study is incidence of complete response (CR) of CIS at any time. The FDA had granted Fast Track Designation to the pivotal trial based on Phase I data. In December 2019, the FDA granted ImmunityBio Breakthrough Therapy Designation based on interim Phase 2 data indicating the primary endpoint of the trial was already met.

ImmunityBio’s IL-15 superagonist Anktiva (N-803)

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by affecting the development, maintenance, and function of the natural killer (NK) and T cells. N-803 is a novel IL-15 superagonist complex consisting of an IL-15 mutant (IL-15N72D) bound to an IL-15 receptor α/IgG1 Fc fusion protein. Its mechanism of action is direct specific stimulation of CD8+ T cells and NK cells through beta gamma T-cell receptor binding (not alpha) while avoiding T-reg stimulation. N-803 has improved pharmacokinetic properties, longer persistence in lymphoid tissues and enhanced anti-tumor activity compared to native, non-complexed IL-15 in vivo.

N-803 is currently being evaluated for adult patients in two clinical NMIBC trials. QUILT 2.005 is investigating use of N-803 in combination with BCG for patients with BCG-naïve NMIBC; QUILT 3.032 is studying N-803 in combination with BCG in patients with BCG-unresponsive NMIBC.

Mechanism of Action & Contribution of N-803 (Anktiva) and BCG for Bladder Cancer

Trained immunity10 is a recently discovered immune system response triggered by BCG. Natural Killer (NK) and T cells11 are activated by BCG resulting in bladder cancer cell death. When an appropriate secondary stimulus is administered along with BCG, that trained immune response is enhanced to induce immune memory resulting in a prolonged duration12 of immunological response. N-803, an IL-15 superagonist which proliferates NK and T cells13, serves as this enhancing secondary boost and augments the immunological response when given in combination with BCG. This mechanism of action of inducing trained innate immune memory, through the combination of N-803 and BCG, accounts for the prolonged 24-month durable complete response reported in this trial.

On February 14, 2022 AVEO Oncology (Nasdaq: AVEO), a commercial stage, oncology-focused biopharmaceutical company, reported that new long-term progression free survival (PFS) data from the Phase 3 TIVO-3 study, which compares FOTIVDA (tivozanib) to Nexavar (sorafenib) in advanced renal cell carcinoma (RCC) patients following two or more prior systemic therapies, are being presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium being held in San Francisco on February 17th – 19th (Press release, AVEO, FEB 14, 2022, View Source [SID1234608074]).

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"The long-term PFS data we are presenting at the ASCO (Free ASCO Whitepaper) GU meeting this week further strengthen the body of data supporting FOTIVDA as a potential standard of care in third- and fourth-line RCC treatment. This marks the first presentation of five year follow-up data for patients being treated in the third- or fourth-line RCC setting and helps guide clinical treatment," said Michael Bailey, President and Chief Executive Officer of AVEO. "We are excited to report that the five year follow-up data announced today show that patients receiving FOTIVDA are up to five times more likely to experience long-term progression free survival as compared to sorafenib. Long-term follow-up of the TIVO-3 study suggests early and consistent PFS benefit with FOTIVDA ultimately may be associated with the trend toward improved overall survival."

ASCO GU 2022 TIVO-3 Phase 3 Five Year Follow-up Data include:

Investigator-assessment of PFS with long-term follow-up for TIVO-3 is consistent with the primary independent review committee.
Landmark five year follow-up data show PFS rates are consistently higher with FOTIVDA vs. sorafenib, with 12% vs. 2% and 8% vs. 0% at three and four years, respectively. Long-term PFS represents a clinically meaningful outcome for patients in the third- and fourth-line treatment setting.
Long term OS was also analyzed, and a non significant trend favoring FOTIVDA continued to emerge with accumulation of events (HR, 0.89).
ASCO GU 2022 Poster/Abstract Details:
Title: Long-term PFS from TIVO-3: Tivozanib (TIVO) vs. sorafenib (SOR) in relapsed/refractory (R/R) advanced RCC
First Author: Michael B. Atkins MD
Abstract: 362
Track: Renal Cell Cancer
Date and Time: February 19, 2022 at 10 a.m. Eastern Time

Details on the presentation are available on the 2022 ASCO (Free ASCO Whitepaper) GU website (click here). The poster scheduled to be presented at the 2022 ASCO (Free ASCO Whitepaper) GU Cancers Symposium will be available on the Publications page of the AVEO Oncology website (click here) subsequent to the presentation.

About FOTIVDA (tivozanib)

FOTIVDA (tivozanib) is an oral, next-generation vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). It is a potent, selective inhibitor of VEGFRs 1, 2, and 3 with a long half-life designed to improve efficacy and tolerability. AVEO received U.S. Food and Drug Administration (FDA) approval for FOTIVDA on March 10, 2021 for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. FOTIVDA was approved in August 2017 in the European Union and other countries in the territory of its partner EUSA Pharma (UK) Limited for the treatment of adult patients with advanced RCC. FOTIVDA has been shown to significantly reduce regulatory T-cell production in preclinical models.2 FOTIVDA was discovered by Kyowa Kirin.

INDICATIONS

FOTIVDA is indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension and Hypertensive Crisis: Control blood pressure prior to initiating FOTIVDA. Monitor for hypertension and treat as needed. For persistent hypertension despite use of anti-hypertensive medications, reduce the FOTIVDA dose.

Cardiac Failure: Monitor for signs or symptoms of cardiac failure throughout treatment with FOTIVDA.

Cardiac Ischemia and Arterial Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe arterial thromboembolic events, such as myocardial infarction and stroke.

Venous Thromboembolic Events: Closely monitor patients who are at increased risk for these events. Permanently discontinue FOTIVDA for severe venous thromboembolic events.

Hemorrhagic Events: Closely monitor patients who are at risk for or who have a history of bleeding.

Proteinuria: Monitor throughout treatment with FOTIVDA. For moderate to severe proteinuria, reduce the dose or temporarily interrupt treatment with FOTIVDA.

Thyroid Dysfunction: Monitor before initiation and throughout treatment with FOTIVDA.

Risk of Impaired Wound Healing: Withhold FOTIVDA for at least 24 days before elective surgery. Do not administer for at least 2 weeks following major surgery and adequate wound healing. The safety of resumption of FOTIVDA after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Discontinue FOTIVDA if signs or symptoms of RPLS occur.

Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

Allergic Reactions to Tartrazine: The 0.89 mg capsule of FOTIVDA contains FD&C Yellow No.5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions were fatigue, hypertension, diarrhea, decreased appetite, nausea, dysphonia, hypothyroidism, cough, and stomatitis, and the most common Grade 3 or 4 laboratory abnormalities (≥5%) were sodium decreased, lipase increased, and phosphate decreased.

DRUG INTERACTIONS

Strong CYP3A4 Inducers: Avoid coadministration of FOTIVDA with strong CYP3A4 inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise not to breastfeed.
Females and Males of Reproductive Potential: Can impair fertility.
Hepatic Impairment: Adjust dosage in patients with moderate hepatic impairment. Avoid use in patients with severe hepatic impairment.

To report SUSPECTED ADVERSE REACTIONS, contact AVEO Pharmaceuticals, Inc. at 1-833-FOTIVDA (1-833-368-4832) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FOTIVDA Full Prescribing Information which is available at www.FOTIVDA.com.

About Advanced Renal Cell Carcinoma

According to the American Cancer Society’s 2021 statistics, renal cell carcinoma (RCC) is the most common type of kidney cancer, which is among the ten most common cancers in both men and women. Approximately 73,750 new cases of kidney cancer will be diagnosed annually and about 14,830 people will die from this disease. In patients with late-stage disease, the five-year survival rate is 13%. Agents that target the vascular endothelial growth factor (VEGF) pathway have shown significant antitumor activity in RCC.3 According to a 2019 publication, 50% of the approximately 10,000 patients who progress following two or more lines of therapy choose not to receive further treatment,4 which may be attributable to tolerability concerns and a lack of data to support evidence-based treatment decisions in this highly relapsed or refractory patient population.