Shares of Aravive soar on its ovarian cancer drug

Aravive reports data from ongoing Phase 1b portion of AVB-500 trial

Aravive (ARAV) announced new data from the ongoing Phase 1b portion of the Phase 1b/2 clinical trial of AVB-500 in platinum-resistant recurrent ovarian cancer patients.

Ovarian cancer data sends shares sharply higher, Stockwinners

The data from the first 31 patients treated at the 10 mg/kg dose are maturing and affirm earlier findings on the relationship between AVB-500 levels and anti-tumor response.

In this data analysis, high serum drug levels of AVB-500 were strongly predictive of anti-tumor activity with statistically significant correlation to progression-free survival.

PFS is the primary endpoint for platinum-resistant ovarian cancer clinical trials.

At the 10 mg/kg dose, patients that met or exceeded the minimal efficacious concentration of AVB-500 demonstrated a greater than four-fold increase in median PFS over those with low exposure and approximately two-fold improvement in overall response rate, including one complete response.

How AVB-500 works, Stockwinners

Patients who achieved sufficient AVB-500 exposure also showed improvements in duration of response and clinical benefit rate, with reduced chance of progressing by 3.2-fold.

The open-label, Phase 1b portion of the Phase 1b/2 clinical trial of AVB-500 enrolled patients with platinum-resistant recurrent ovarian cancer in two cohorts, one investigating a combination of AVB-500 with pegylated liposomal doxorubicin and the other a combination with paclitaxel.

All patients were treated with 10mg/kg AVB-500 every other week.

The company previously reported drug exposure-response relationship among the initial patients receiving 10 mg/kg.

The study identified a minimal efficacious concentration that is consistent with at least 95% target engagement based on independent pharmacokinetic modeling.

At the 10 mg/kg dose, 17 of 31 patients in the study achieved the minimal efficacious concentration after the first dose of AVB-500. The baseline characteristics, demographics and safety parameters were comparable between patients who achieved the minimal efficacious concentration and those who fell below that threshold.

The analysis shows that the clinical benefit at this dose level in the study can be primarily attributed to AVB-500 exposure.

Other notable findings: The patient with CR that is pending confirmation achieved the MEC of AVB-500 and was on paclitaxel. She had a baseline serum GAS6 level typical of the platinum-resistant ovarian cancer population and two-fold higher than that observed in healthy volunteers. She also exhibited poor prognostic factors, including two prior lines of therapy and platinum-free interval of less than three months.

Among the patients who responded to AVB-500, four of seven remain responders and continue on study, and two patients remain on AVB-500 as a single agent.

All four patients achieved the minimal efficacious AVB-500 concentration. Among the 13 patients whose best response was SD, four achieved the MEC of AVB-500 and remain on study. One SD patient, whose trough level was below the minimal efficacious concentration, did not progress but withdrew consent.

Because the study is still ongoing and includes only patients above the MEC, duration of response and PFS may continue to evolve.

These data confirm the company’s strategy to investigate higher doses in the current Phase 1b study, to determine if a greater proportion of patients can exceed the MEC.

According to our modeling, a dose of 20 mg/kg should allow greater than 90% of the patients to achieve the MEC.

It is anticipated 6 to 12 patients will be treated with 15mg/kg and an additional 12 patients will be treated with 20mg/kg.

An independent safety monitoring group will review data from the 15mg/kg group prior to escalation to the 20 mg/kg dose.

AVB-500 continues to be well-tolerated and there have been no serious and unexpected adverse reactions or dose-limiting toxicities to date.

ARAV closed at $6.51, last traded at $17.20.

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Watch shares of Mirati Therapeutics

Mirati presents data from sitravatinib in combination with nivolumab trials

Mirati Therapeutics (MRTX) announced the presentation of initial data from its ongoing Phase 2 clinical trial of sitravatinib in combination with nivolumab in metastatic urothelial cancer patients with documented progression on a platinum-chemotherapy and checkpoint inhibitor.

Mirati is in focus on cancer data, Stockwinners

The data were presented in an oral presentation at the Society of Immunotherapy of Cancer 34th Annual Meeting.

Preliminary results from the ongoing Phase 1 study of neoadjuvant sitravatinib combined with nivolumab in patients with resectable squamous cell carcinoma of the oral cavity, SNOW trial, were also presented in a poster session.

The preliminary data suggest that the combination of neoadjuvant sitravatinib and nivolumab is safe and active in patients with squamous cell carcinoma of the oral cavity who are candidates for resection.

Chart shows Sitravatinib in action, Stockwinners

Tumor reduction was observed in all eight patients who were eligible for evaluation, including one complete pathological response.

All patients received postoperative radiation therapy, and none required postoperative chemotherapy.

With a median follow-up of 31.4 weeks, all patients are alive with no disease recurrence to date.

In most patients, treatment with sitravatinib led to a decrease in myeloid-derived suppressor cells and a shift towards M1-type macrophages in the tumor microenvironment, supporting previous preclinical findings.

“Sitravatinib is a spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases, including TAM family receptors that has the potential to increase responsiveness in patients whose tumors are resistant to checkpoint inhibitors. The initial efficacy data from the Phase 2 clinical trial presented today in patients with checkpoint refractory mUC is promising and extends the clinical benefit data beyond what has already been demonstrated by sitravatinib combined with nivolumab in checkpoint refractory non-small cell lung cancer,” said Charles Baum, M.D., CEO of Mirati.

Sitravatinib offers hope for cancer patients, Stockwinners

“In addition, we are evaluating sitravatinib in patients who have progressed on checkpoint therapy, including those with NSCLC and renal cell cancer, and we continue to expand development efforts of sitravatinib through our collaboration with BeiGene in multiple indications including NSCLC, renal cell cancer, hepatocellular cancer, ovarian cancer, and gastric cancer.”

MRTX closed at $104.78.

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ImmunoGen higher on FDA decision

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine , Stockwinners
ImmunoGen announces FDA fast track designation for mirvetuximab soravtansine

ImmunoGen (IMGN) announced that the U.S. FDA has granted Fast Track designation for its lead program, mirvetuximab soravtansine.

The designation is for the treatment of patients with medium to high folate receptor alpha-positive platinum-resistant ovarian cancer who received at least one, but no more than three prior systemic treatment regimens, and for whom single-agent chemotherapy is appropriate as the next line of therapy.

Mirvetuximab soravtansine is being evaluated in the FORWARD I Phase 3 trial.

The trial is designed to randomize 333 patients 2:1 to receive either mirvetuximab soravtansine or the physician’s choice of single-agent chemotherapy.

Eligibility criteria include patients with platinum-resistant ovarian cancer that express medium or high levels of FRalpha who have been treated with up to three prior regimens.

The primary endpoint of this study is Progression Free Survival, which is being assessed in the entire study population and in the subset of patients with high FRalpha expression.

Enrollment of FORWARD I was completed ahead of schedule in April 2018 and ImmunoGen expects to report top-line results from the FORWARD I trial in the first half of 2019. ImmunoGen is partnering with the Gynecologic Oncology Group Foundation Inc., a leader in clinical research in gynecologic malignancies, on FORWARD I, which is being conducted in North America and Europe.

This trial is intended to support full marketing approval of mirvetuximab for patients with platinum-resistant ovarian cancer.

Mirvetuximab soravtansine is also being assessed in multiple combinations in the FORWARD II trial.

FORWARD II is a Phase 1b/2 study of mirvetuximab in combination with Avastin, or Keytruda in patients with FRalpha-positive platinum-resistant ovarian cancer, primary peritoneal, or fallopian tube tumors, as well as a triplet combination of mirvetuximab plus carboplatin and Avastin in patients with platinum-sensitive ovarian cancer.

IMGN closed at $10.01, it last traded at $10.65.


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Laboratory stocks tumble on CMS proposal!

Medical diagnostics stocks slide after CMS proposes cuts

Medical diagnostics stocks slide after CMS proposes cuts. See Stockwinners.com for details

Following the news of the proposed Protecting Access to Medicare Act changes, including a bigger than expected reduction in clinical lab fee schedule spending, Raymond James analyst Nicholas #Jansen downgraded Quest Diagnostics (DGX) to Market Perform.

Meanwhile, his peer at Craig-Hallum told investors that the preliminary PAMA impact is near “the worst-case outcome” for the clinical lab industry.

MOVING TO THE SIDELINES ON QUEST

Raymond James’ Jansen downgraded Quest Diagnostics to Market Perform from Outperform following the preliminary 2018 Clinical Laboratory Fee Schedule, or #CLFS , rates released Friday evening, which he believes were close to the worst-case reduction and create an overhang for the sector.

Based on the proposal, there is a 21.9% reduction expected over the coming years, with 58% of the total codes seeing the maximum 10% reduction in 2018, he explained.

The analyst argued that the CLFS came in steeper than anticipated and will likely make it more difficult for Quest to achieve previously communicated 2020 forecasts.

In a statement over the weekend, Quest Diagnostics said it was “deeply disappointed that CMS has issued draft 2018 Medicare payment rates that are not market-based and derived from flawed market data collection that excluded key components of the lab market,” adding that it plans to “explore all available options, including the courts if necessary.”

BUYING ON WEAKNESS

Commenting on the PAMA news, Craig-Hallum analyst Kevin #Ellich said that the preliminary impact is near the worst-case outcome for the clinical lab industry with a 9%-10% reduction in CLFS spending.

The analyst told investors that he thinks the labs stocks could come under pressure and that he would use the weakness as a buying opportunity for LabCorp of America (LH), NeoGenomics (NEO) and Exact Sciences (EXAS).

Additionally, Ellich pointed out that he expects Quest Diagnostics and LabCorp to manage cuts and gain market share. Meanwhile, SunTrust analyst David MacDonald argued in a research note of his own that the exposure of LabCorp and Quest Diagnostics is “manageable,” and that he recommends buying the shares on any “meaningful” weakness.

FEW WINNERS

Canaccord analyst Mark #Massaro also commented on the #PAMA announcement, saying the cuts were greater than he expected and that he believes the brunt of the cuts will impact “mom and pop” small labs that lack scale.

This environment will allow lab leaders LabCorp, Quest, and even Genomic Health to consolidate weaker players, he contended.

Nonetheless, the analyst noted that he views LabCorp, Quest Diagnostics and GenMark (GNMK) as the “losers” after the news, and Genomic Health (GHDX), VeraCyte (VCYT) and Vermillion (VRML) as among the “few winners.”

PRICE ACTION

In Monday’s trading, shares of Quest Diagnostics have dropped over 7% to below $95, while LabCorp’s stock has slipped nearly 4% to $149 per share.


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Clovis Reports Positive Cancer Data, Shares Rise

Phase 3 ARIEL3 study of rucaparib met primary, key secondary endpoints

CLVS to submit NDA to FDA

Clovis Oncology (CLVS) announced that comprehensive data from the Phase 3 ARIEL3 study of rucaparib for maintenance treatment of advanced ovarian cancer were published online in The Lancet.

The ARIEL3 study successfully achieved its primary and key secondary endpoints – improved progression-free survival by both investigator review and blinded independent central review, respectively – in each of the three populations studied, as well as its exploratory endpoints.

#ARIEL3 is a double-blind, placebo-controlled, phase 3 trial of rucaparib that enrolled 564 women with platinum-sensitive, high-grade ovarian, fallopian tube, or primary peritoneal cancer.

The primary efficacy analysis evaluated three prospectively defined molecular sub-groups in a step-down manner: 1) tumor BRCA mutant patients, inclusive of germline and somatic mutations of BRCA (n=196); 2) HRD patients, including BRCA-mutant patients and BRCA wild-type with high loss of heterozygosity, or LOH-high patients (n=354), and, finally, 3) the intent-to-treat population, or all patients treated in ARIEL3 (n=564).

The study achieved its primary endpoint of improved PFS by investigator review in each of three populations.

PFS was also improved in the rucaparib group compared with placebo by BICR, a key secondary endpoint, in all three populations.

In addition, rucaparib improved objective response rate vs placebo among evaluable trial participants in all three study populations.

According to the paper, treatment emergent adverse events in the ARIEL3 rucaparib group were generally managed with dose modifications and not associated with increased mortality or morbidity compared with the placebo group. Safety data from ARIEL3 demonstrate consistency with prior rucaparib studies.

Based on the ARIEL3 findings, Clovis Oncology plans to submit a supplemental New Drug Application to the U.S. FDA for a second line or later maintenance treatment indication in ovarian cancer by the end of October 2017.

In early 2018, the Company plans to file an MAA in Europe for the maintenance treatment indication upon receipt of a potential approval for the treatment indication.

PRICE  ACTION

CLVS has a 52-week trading range of $25.50 – $99.45. Shares closed at $70.61.


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AstraZeneca receives $8.5 Billion from Merck

AstraZeneca receives $1.6B upfront in oncology collaboration with Merck

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AstraZeneca (AZN) and Merck (MRK) announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza for multiple cancer types.

#Lynparza is an oral poly ADP ribose polymerase, or PARP, inhibitor currently approved for BRCA-mutated #ovarian cancer in multiple lines of treatment.

The companies will develop and commercialize Lynparza jointly, both as monotherapy and in combination with other potential medicines.

Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi and Keytruda.

The companies will also jointly develop and commercialize AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase pathway, currently being developed for multiple indications including thyroid cancer. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialization costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities.

Gross profits from Lynparza and selumetinib Product Sales generated through monotherapies or combination therapies will be shared equally.

Merck will fund all development and commercialization costs of Keytruda in combination with Lynparza or selumetinib. AstraZeneca will fund all development and commercialization costs of #Imfinzi in combination with Lynparza or selumetinib. AstraZeneca will continue to manufacture Lynparza and selumetinib.

As part of the agreement, Merck will pay AstraZeneca up to $8.5B in total consideration, including $1.6B upfront, $750M for certain license options and up to $6.15B contingent upon successful achievement of future regulatory and sales milestones.

Under the terms of the agreement, AstraZeneca anticipates approximately $1B to be recorded under Externalization Revenue in 2017.

OTHER EVENTS

AstraZeneca plunged in pre-market trading as Phase III MYSTIC trial endpoint not met. AstraZeneca announced progression-free survival results for the Phase III #MYSTIC trial, a randomized, open-label, multi-center, global trial of Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic 1st-line non-small cell lung cancer.

MYSTIC TRIAL:

AstraZeneca has announced progression-free survival, or PFS, results for the Phase III MYSTIC trial, which is testing Imfinzi monotherapy or Imfinzi in combination with tremelimumab versus platinum-based standard-of-care chemotherapy in previously-untreated patients with metastatic first line non-small cell lung cancer.

The combination did not meet the primary endpoint of improving PFS compared to standard-of-care in patients whose tumors express PD-L1 on 25% or more of their cancer cells.

PRICE ACTION

In Thursday’s trading, shares of AstraZeneca have dropped over 15% to $28.72, while Bristol’s (BMY) stock has slipped almost 5% to $53.23. MYSTIC trial failure is a negative read-through for Bristol-Myers’ combo of Opdivo + Yervoy in the ongoing CheckMate-227 trial.

Meanwhile, Merck is up over 3% to $63.75.

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Clovis Oncology reports positive ovarian cancer results, Shares Soars

Clovis Oncology  announced topline data from the confirmatory phase 3 #ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint for Ovarian Cancer.

Shares of competitor Tesaro (TSRO) tumble on the news

CLVS to submit NDA to FDAShares of Clovis Oncology (CLVS) are surging after the company this morning announced topline data from the confirmatory phase 3 ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival, or PFS, by investigator review in each of the three populations studied.

Clovis Oncology (CLVS) announced topline data from the confirmatory phase 3 #ARIEL3 trial of rucaparib, which successfully achieved the primary endpoint of improved progression-free survival, or #PFS, by investigator review in each of the three populations studied. PFS was also improved in the rucaparib group compared with placebo by blinded independent central review, or #BICR, a key secondary endpoint.

Based on these findings, the company plans to submit a supplemental New Drug Application, or sNDA, within the next four months for a second-line and later maintenance treatment indication for all women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. #NDA

“We are very pleased with these positive #ARIEL3 topline results that strongly demonstrate the potential of rucaparib to help women with platinum-sensitive, advanced ovarian cancer,” said Patrick Mahaffy, President and CEO of Clovis Oncology.

“These results reinforce the potentially foundational role of #rucaparib in the management of advanced ovarian cancer, as demonstrated by both investigator review and the blinded independent central review. Most importantly, we are grateful to the patients, caregivers and investigators who participated in this study. We look forward to sharing these data in greater detail at a medical meeting later this year and submitting our sNDA as rapidly as possible, with the ultimate goal of making rucaparib available to more women battling ovarian cancer.”

Possible $40 Gain

Janney Capital’s analyst Debjit #Chattopadhyay previewed some potential outcomes for the release of topline data from Clovis’ (CLVS) ARIEL3 trial, which is expected over the next two weeks. If Hazard Ratios in g+sBRCA patients are in below 0.3, he sees Clovis shares potentially trading up to $85-$100 per share, which, at the high end, would be about $40 above Clovis’ Friday closing price of $60.

In such a scenario, he thinks competitor Tesaro (TSRO) sliding to $80-$90. With HRs in the range of 0.3-0.35, which he gives a 70% probability of occurring, he sees Clovis trading at $75-$85 and Tesaro falling to $90-$100. Tesaro has a competing drug for ovarian cancer.

PRICE ACTION

In pre-market trading on Monday, CLVS is up $26 to $86.00 in heavy trading. TSRO is down $16 to $128.

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