On May 5, 2021 Unum Group (NYSE: UNM) reported net income of $153.0 million ($0.75 per diluted common share) for the first quarter of 2021, compared to net income of $161.0 million ($0.79 per diluted common share) for the first quarter of 2020 (Press release, Unum Therapeutics, MAY 5, 2021, View Source [SID1234579232]).

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Unum Group Reports First Quarter 2021 Results
Included in net income for the first quarter of 2021 are the net after-tax loss from the second phase of the Closed Block individual disability reinsurance transaction of $56.7 million ($0.27 per diluted common share), the after-tax amortization of the cost of reinsurance of $15.8 million ($0.08 per diluted common share), and a net after-tax realized investment gain on the Company’s investment portfolio, excluding the net realized investment gain associated with the completion of the second phase of the Closed Block individual disability reinsurance transaction, of $13.5 million ($0.06 per diluted common share). Included in net income for the first quarter of 2020 is a net after-tax realized investment loss on the Company’s investment portfolio of $113.1 million ($0.56 per diluted common share). Excluding the items above, after-tax adjusted operating income was $212.0 million ($1.04 per diluted common share) in the first quarter of 2021, compared to $274.1 million ($1.35 per diluted common share) in the first quarter of 2020.

"Our first quarter results reflect the dynamics of the world around us with good growth results, pressured by high, yet improving, levels of mortality," said Richard P. McKenney, president and chief executive officer. "With vaccines rolling out and a better economy, the current trends show continued improvement. Looking forward, our market leadership and financial underpinnings position us well to drive growth as the recovery builds in the second half of the year."

RESULTS BY SEGMENT

We measure and analyze our segment performance on the basis of "adjusted operating income" or "adjusted operating loss", which differ from income before income tax as presented in our consolidated statements of income due to the exclusion of net realized investment gains and losses, amortization of cost of reinsurance, and certain other items. These performance measures are in accordance with GAAP guidance for segment reporting, but they should not be viewed as a substitute for income before income tax or net income.

Unum US Segment

Unum US reported adjusted operating income of $115.7 million in the first quarter of 2021, a decrease of 55.8 percent from $261.8 million in the first quarter of 2020. Premium income for the segment was $1,525.8 million in the first quarter of 2021, which was generally consistent with the $1,527.7 million in the first quarter of 2020. Net investment income for the segment was $179.7 million in the first quarter of 2021, which was consistent with the $179.6 million in the first quarter of 2020.

Within the Unum US operating segment, the group disability line of business reported a 16.0 percent decrease in adjusted operating income to $64.1 million in the first quarter of 2021, compared to $76.3 million in the first quarter of 2020. Premium income for the group disability line of business increased 1.0 percent to $672.9 million in the first quarter of 2021, compared to $666.2 million in the first quarter of 2020 due to higher sales in our short-term disability product line. Net investment income increased 4.3 percent to $97.4 million in the first quarter of 2021, compared to $93.4 million in the first quarter of 2020, driven by higher miscellaneous investment income, partially offset by a decline in the yield on invested assets and a lower level of invested assets. The benefit ratio for the first quarter of 2021 was 74.8 percent, compared to 73.2 percent in the first quarter of 2020, due to higher claims incidence in the short-term disability product line, resulting from the impacts of COVID-19, partially offset by favorable claim recoveries in our group long-term disability product line. Group long-term disability sales were $31.1 million in the first quarter of 2021, which was generally consistent with the $31.4 million in the first quarter of 2020. Group short-term disability sales were $24.1 million in the first quarter of 2021, an increase of 69.7 percent from $14.2 million in the first quarter of 2020. Persistency in the group long-term disability product line was 90.7 percent for the first quarter of 2021, compared to 90.6 percent for the first quarter of 2020. Persistency in the group short-term disability product line was 86.1 percent for the first quarter of 2021, compared to 86.1 percent for the first quarter of 2020.

The group life and accidental death and dismemberment line of business reported an adjusted operating loss of $58.3 million in the first quarter of 2021, compared to adjusted operating income of $70.4 million in the first quarter of 2020. Premium income for this line of business decreased 1.1 percent to $451.4 million in the first quarter of 2021, compared to $456.2 million in the first quarter of 2020, driven primarily by lower prior period sales, partially offset by higher persistency. Net investment income decreased 3.1 percent to $24.9 million in the first quarter of 2021, compared to $25.7 million in the first quarter of 2020, due to decline in the yield on invested assets. The benefit ratio in the first quarter of 2021 was 98.8 percent, compared to 70.6 percent in the first quarter of 2020, due primarily to higher claims incidence in the group life product line resulting from the impacts of COVID-19. Sales of group life and accidental death and dismemberment products increased 7.5 percent in the first quarter of 2021 to $30.2 million, compared to $28.1 million in the first quarter of 2020. Persistency in the group life product line was 90.1 percent for the first quarter of 2021, compared to 88.4 percent for the first quarter of 2020. Persistency in the accidental death and dismemberment product line was 89.7 percent for the first quarter of 2021, compared to 87.9 percent for the first quarter of 2020.

The supplemental and voluntary line of business reported a decrease of 4.5 percent in adjusted operating income to $109.9 million in the first quarter of 2021, compared to $115.1 million in the first quarter of 2020. Premium income for the supplemental and voluntary line of business decreased to $401.5 million in the first quarter of 2021, compared to $405.3 million in the first quarter of 2020, with a decline in the voluntary benefits product line, mostly offset by growth in the individual disability and dental and vision product lines. Net investment income decreased 5.1 percent to $57.4 million in the first quarter of 2021, compared to $60.5 million in the first quarter of 2020, due to a decline in the yield on invested assets, partially offset by an increase in the level of invested assets. The benefit ratio for the individual disability product line was 42.4 percent for the first quarter of 2021, compared to 52.1 percent for the first quarter of 2020, due to lower claims incidence and higher mortality. The benefit ratio for the voluntary benefits product line was 39.3 percent in the first quarter of 2021, compared to 32.7 percent for the first quarter of 2020, due to higher claims incidence in the life product line, resulting from the impacts of COVID-19. The benefit ratio for the dental and vision product line was 73.2 percent for the first quarter of 2021, compared to 65.1 percent for the first quarter of 2020, due primarily to higher claims incidence. Relative to the first quarter of 2020, sales in the individual disability product line declined 25.1 percent in the first quarter of 2021 to $17.0 million. Sales in the voluntary benefits product line declined 21.5 percent in the first quarter of 2021 to $101.0 million. Sales in the dental and vision product line totaled $8.0 million for the first quarter of 2021, a decrease of 25.9 percent compared to the first quarter of 2020. Persistency in the individual disability product line was 90.2 percent for the first quarter of 2021, compared to 88.9 percent for the first quarter of 2020. Persistency in the voluntary benefits product line was 74.3 percent for the first quarter of 2021, compared to 72.4 percent for the first quarter of 2020. Persistency in the dental and vision product line was 87.4 percent for the first quarter of 2021, compared to 81.9 percent for the first quarter of 2020.

Unum International

The Unum International segment reported adjusted operating income of $26.4 million in the first quarter of 2021, an increase of 36.1 percent from $19.4 million in the first quarter of 2020. Premium income increased 6.0 percent to $174.4 million in the first quarter of 2021, compared to $164.6 million in the first quarter of 2020. Net investment income was $26.0 million in the first quarter of 2021, compared to $26.5 million in the first quarter of 2020. Sales decreased 2.9 percent to $23.2 million in the first quarter of 2021, compared to $23.9 million in the first quarter of 2020.

The Unum UK line of business reported adjusted operating income, in local currency, of £18.6 million in the first quarter of 2021, an increase of 35.8 percent from £13.7 million in the first quarter of 2020. Premium income was £110.5 million in the first quarter of 2021, a decrease of 2.9 percent from £113.8 million in the first quarter of 2020, driven by an increase in ceded premiums in the group life product line, partially offset by both higher sales and persistency in the group life product line and rate increases in the group long-term disability product line. Net investment income was £17.4 million in the first quarter of 2021, a decrease of 9.8 percent from £19.3 million in the first quarter of 2020, due to lower miscellaneous investment income and a lower yield on fixed-rate bonds, partially offset by higher investment income from inflation index-linked bonds. The benefit ratio in the first quarter of 2021 was 75.3 percent, compared to 80.5 percent in the first quarter of 2020, due primarily to favorable mortality experience and lower claims incidence in both the group long-term disability and group critical illness product lines, partially offset by higher claims incidence in the group life product line, resulting from the impacts of COVID-19. Sales decreased 13.3 percent to £14.3 million in the first quarter of 2021, compared to £16.5 million in the first quarter of 2020. Persistency in the group long-term disability product line was 87.0 percent for the first quarter of 2021, compared to 90.1 percent for the first quarter of 2020, resulting from pricing discipline. Persistency in the group life product line was 87.2 percent for the first quarter of 2021, compared to 86.3 percent for the first quarter of 2020. Persistency in the supplemental product line was 88.2 percent for the first quarter of 2021, compared to 91.2 percent for the first quarter of 2020.

Colonial Life Segment

Colonial Life reported a 9.6 percent decrease in adjusted operating income to $73.3 million in the first quarter of 2021, compared to $81.1 million in the first quarter of 2020. Premium income decreased 1.9 percent to $426.4 million in the first quarter of 2021, compared to $434.7 million in the first quarter of 2020, due to a decline in sales, partially offset by higher persistency. Net investment income was $37.7 million in the first quarter of 2021, which was consistent with the first quarter of 2020. The benefit ratio was 55.4 percent in the first quarter of 2021, compared to 52.4 percent in the first quarter of 2020, with unfavorable experience in the life product line, resulting from the impacts of COVID-19, partially offset by favorable experience in the accident, sickness, and disability line of business.

Sales decreased 9.2 percent to $90.2 million in the first quarter of 2021, compared to $99.3 million in the first quarter of 2020. Persistency in Colonial Life was 78.4 percent for the first quarter of 2021, compared to 76.8 percent for the first quarter of 2020.

Closed Block Segment

The Closed Block segment reported adjusted operating income of $97.0 million in the first quarter of 2021, which excludes the impacts from the second phase of the Closed Block individual disability reinsurance transaction of $139.3 million and the amortization of cost of reinsurance related to the Closed Block individual disability reinsurance transaction of $20.0 million, compared to $29.7 million in the first quarter of 2020. Premium income for this segment increased 3.0 percent to $251.7 million in the first quarter of 2021, compared to $244.4 million in the first quarter of 2020, due to premium rate increases on certain in-force business in the long-term care line of business, partially offset by continued policy terminations and maturities in the individual disability line of business. Net investment income decreased 11.6 percent to $297.2 million in the first quarter of 2021, compared to $336.1 million in the first quarter of 2020, due to a decrease in the level of invested assets supporting individual disability resulting from the reinsurance transaction, partially offset by higher miscellaneous investment income, primarily related to increases in the net asset values on our private equity partnerships, and an increase in the level of invested assets supporting long-term care. In connection with the completion of the second phase of the Closed Block individual disability reinsurance transaction, we recognized a net realized investment gain of $67.6 million.

The interest adjusted loss ratio for the long-term care line of business was 77.7 percent in the first quarter of 2021, compared to an interest adjusted loss ratio of 81.0 percent in the first quarter of 2020, driven primarily by higher claimant mortality, partially offset by higher submitted claims. The interest adjusted loss ratio for long-term care for the rolling twelve months ended March 31, 2021, excluding the update of assumptions during the fourth quarter of 2020, was 68.1 percent which is significantly below our long-term expected range. The interest adjusted loss ratio for the individual disability line of business, excluding the impacts from the reinsurance transaction, was 68.9 percent in the first quarter of 2021, compared to 84.5 percent in the first quarter of 2020, driven primarily by lower submitted claims.

Corporate Segment

The Corporate segment reported an adjusted operating loss of $38.9 million in the first quarter of 2021 compared to an adjusted operating loss of $45.9 million in the first quarter of 2020, resulting primarily from an increase in the level of invested assets and lower operating expenses.

OTHER INFORMATION

Shares Outstanding

The Company’s weighted average number of shares outstanding, assuming dilution, was 204.7 million for the first quarter of 2021, compared to 203.4 million for the first quarter of 2020. Shares outstanding totaled 204.2 million at March 31, 2021. The Company did not repurchase shares during the first quarter of 2021.

Capital Management

At March 31, 2021, the weighted average risk-based capital ratio for the Company’s traditional U.S. insurance companies was approximately 370 percent, and cash and marketable securities in the holding companies equaled $1,664 million.

Book Value

Book value per common share as of March 31, 2021 was $51.77, compared to $48.21 at March 31, 2020.

Outlook

As previously announced, the Company expects a modest decline in after-tax adjusted operating income per share for full-year 2021 compared to full-year 2020. The Company also anticipates a strong recovery in after-tax adjusted operating income per share in the second half of 2021 as the expected impacts of the COVID-19 pandemic subside.

NON-GAAP FINANCIAL MEASURES

We analyze our performance using non-GAAP financial measures. A non-GAAP financial measure is a numerical measure of a company’s performance, financial position, or cash flows that excludes or includes amounts that are not normally excluded or included in the most directly comparable measure calculated and presented in accordance with GAAP. The non-GAAP financial measure of "after-tax adjusted operating income" differs from net income as presented in our consolidated operating results and income statements prepared in accordance with GAAP due to the exclusion of net realized investment gains and losses and amortization of cost of reinsurance as well as certain other items as specified in the reconciliations in the Financial Highlights section below. We believe after-tax adjusted operating income is a better performance measure and better indicator of the profitability and underlying trends in our business.

Realized investment gains or losses depend on market conditions and do not necessarily relate to decisions regarding the underlying business of our segments. Our investment focus is on investment income to support our insurance liabilities as opposed to the generation of realized investment gains or losses. Although we may experience realized investment gains or losses which will affect future earnings levels, a long-term focus is necessary to maintain profitability over the life of the business since our underlying business is long-term in nature, and we need to earn the interest rates assumed in calculating our liabilities.

As previously discussed, we have exited a substantial portion of our Closed Block individual disability product line through the two phases of the reinsurance transaction that were executed in December 2020 and March 2021, respectively. As a result, we exclude the amortization of the cost of reinsurance that was recognized upon the exit of the business related to the ceded reserves for the cohort of policies on claim status. We believe that the exclusion of the amortization of the cost of reinsurance provides a better view of our results from our ongoing businesses.

We may at other times exclude certain other items from our discussion of financial ratios and metrics in order to enhance the understanding and comparability of our operational performance and the underlying fundamentals, but this exclusion is not an indication that similar items may not recur and does not replace net income or net loss as a measure of our overall profitability.

CONFERENCE CALL INFORMATION

Members of Unum Group senior management will host a conference call on Thursday, May 6, at 8:00 a.m. (Eastern Time) to discuss the results of operations for the first quarter. Topics may include forward-looking information, such as the Company’s outlook on future results, trends in operations, and other material information.

The dial-in number for the conference call is (866) 652-5200 for U.S. and Canada (Please ask to be joined to the Unum Group call). For international, the dial-in number is (412) 317-6060 (Please ask to be joined to the Unum Group call). A live webcast of the call will also be available at www.investors.unum.com in a listen-only mode. It is recommended that webcast viewers access the "Investors" section of the Company’s website and opt-in to the webcast approximately 5-10 minutes prior to the start of the call. A replay of the webcast will be available on the Company’s website. A replay of the call will also be available through Thursday, May 13 by dialing (877) 344-7529 (U.S.), (855) 669-9658 (Canada), or (412) 317-0088 (International) – pass code 10154518.

In conjunction with today’s earnings announcement, the Company’s Statistical Supplement for the first quarter of 2021 is available on the "Investors" section of the Company’s website.

On May 5, 2021 Everest Medicines (HKEX 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products in Greater China and other parts of Asia, reported that the Ministry of Food and Drug Safety (MFDS) in South Korea has granted Orphan Drug Designation (ODD) for sacituzumab govitecan-hziy (SG), an investigational treatment for adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease (Press release, Everest Medicines, MAY 5, 2021, View Source [SID1234579231]).

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"We are very pleased that the Ministry of Food and Drug Safety in South Korea has granted Orphan Drug Designation for SG, which we believe has the potential to become a transformative treatment for patients around the world living with metastatic triple-negative breast cancer – a highly aggressive disease with limited treatment options," said Kerry Blanchard, MD, PhD, CEO of Everest Medicines. "Breast cancer is the leading cause of cancer death in women in South Korea, and the incidence for this disease continues to climb rapidly in the region. As we work closely with local regulatory bodies to bring this innovative treatment to patients in South Korea as quickly as possible, we look forward to continuing to expand our international footprint outside of China and adding to our recent New Drug Application submission for SG in Singapore earlier this year."

Orphan Drug Designation is granted by the MFDS to pharmaceuticals used to treat diseases with a prevalence of 20,000 patients or less in the Korean population, pharmaceuticals used to treat diseases for which appropriate therapy and pharmaceuticals have not been developed, or pharmaceuticals that have been significantly improved in terms of safety and/or efficacy, compared to existing alternative therapies.

About Triple-Negative Breast Cancer

Triple-Negative Breast Cancer (TNBC) is a highly aggressive disease and accounts for approximately 15% of all breast cancer types worldwide. The median age of breast cancer diagnoses tends to be younger in Asian than western countries, and the percentage of the TNBC molecular subtype has been increasing in the past 10 years. TNBC cells lack sufficient estrogen, progesterone or HER2 receptor expression to benefit from the use of hormonal or HER2-directed therapy. Overall survival among patients with this form of breast cancer has not changed in the past 20 years, which highlights the need for advances in therapeutic options for these patients.

In South Korea, the growth in breast cancer incidence in recent decades has been one of the fastest in the world.[1] It is the leading cause of cancer death in South Korean women. Statistics from the International Agency for Cancer Research indicate that breast cancer was the leading cause of cancer diagnoses in South Korea in 2020, accounting for 23.7% of total cases.[2]

About Sacituzumab Govitecan-Hziy

Sacituzumab govitecan-hziy (SG) is a first-in-class, antibody-drug conjugate (ADC) directed at TROP-2, a membrane antigen that is over-expressed in many common epithelial cancers. SG is approved in the United States under the trade name Trodelvy.

Under a licensing agreement with Gilead Sciences, Inc., Everest Medicines has exclusive rights to develop, register, and commercialize SG for all cancer indications in Greater China, South Korea, and certain Southeast Asian countries. In October 2020, SG was included in the updated 2020 China Guidelines for the Standardized Diagnosis and Treatment of Advanced Breast Cancer, compiled by the Breast Cancer Expert Committee of the National Cancer Control Center, the Breast Cancer Professional Committee of the Chinese Anti-Cancer Association, and the Cancer Drug Clinical Research Professional Committee of the Chinese Anti-Cancer Association.

On May 5, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that the Chinese Society of Clinical Oncology (CSCO), the most prominent organization in oncology in China, added multiple selinexor regimens to its 2021 Diagnosis and Treatment Guidelines (CSCO Guidelines) for treatment of multiple myeloma and lymphoma (Press release, Antengene, MAY 5, 2021, View Source [SID1234579230]). Three selinexor regimens recommended by the Guideline for the Diagnosis and Treatment of myeloma include: (i) selinexor plus dexamethasone; and (ii) selinexor plus dexamethasone plus bortezomib; and (iii) selinexor plus dexamethasone plus pomalidomide for the treatment of relapsed myeloma. Meanwhile, the guideline has also recommended selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). As the gold standard guiding Chinese oncologists in their clinical practice, the CSCO Guidelines is the one of the most recognized guidelines in China.

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Multiple myeloma (MM) is a malignancy caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. MM is hard to treat and prone to relapse. Despite availability of a number of treatments for relapsed patients, most still succumb to their disease and new treatment options are needed. As a growing number of novel therapies enter into clinical treatment, it has become a challenge to choose the most effective treatment option. Diffuse large B-cell lymphoma (DLBCL) is an aggressive hematologic malignancy that about half of patients with DLBCL will not reach complete remission after receiving first-line treatments, and approximately 60% of patients with rrDLBCL lack effective treatment options.

Selinexor is the world’s first approved oral selective inhibitor of nuclear export (SINE), representing a novel mechanism of action (MoA) in cancer therapy. Selinexor induces the apoptosis of cancer cells through the targeted inhibition of the nuclear export protein XPO1 that leads to the nuclear storage and activation of tumor-suppressor proteins and other growth-regulating (GR) proteins, and by down-regulating the levels of various oncogenic proteins.

Myeloma

For the treatment of relapsed myeloma

Level 1 recommendation for selinexor plus dexamethasone (based on Class 1 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus bortezomib (based on Class 2 evidence)
Level 2 recommendation for selinexor plus dexamethasone plus pomalidomide (based on Class 2 evidence)

The STORM trial is a multicenter, single-arm, open-label trial designed to evaluate the efficacy of selinexor plus dexamethasone (Xd) in patients with relapsed or refractory multiple myeloma (rrMM) that had previous exposure to multiple lines of therapy. Results from this trial showed an objective response rate (ORR) of 26% in rrMM with the Xd combination regimen in patients with rrMM who have received a median of seven previous regimens.

The STOMP trial is a multicenter, open-label, randomized Phase I/II trial designed to evaluate the safety and efficacy of various Xd combination regimens in patients with rrMM. Results from this trial showed a median progression-free survival (mPFS) of 12.2 months in patients that received the combination of selinexor, pomalidomide, and dexamethasone, and an ORR of 60% in patients that received selinexor at recommended Phase II dose (RP2D). In proteasome inhibitor (PI) nonrefractory patients, the combination of selinexor, bortezomib, and dexamethasone has demonstrated an ORR of 84%.

Lymphoma

The guideline has also recommended selinexor for the treatment of lymphoma. In the comments on the treatment of patients with rrDLBCL, the guideline recommended second-line therapies or personalized treatments that have no cross-resistance with the combination of cyclophosphamide, hydroxydaunorubicin, vincristine, and prednisolone (CHOP). In addition, the guideline also noted that multiple novel therapies including chidamide, ibrutinib, zanubrutinib, orelabrutinib, brentuximab vedotin, anti-PD-1 monoclonal antibodies, XPO inhibitor (selinexor), BCL-2 inhibitors have all demonstrated preliminary efficacy either as monotherapy or in combinations.

The SADAL trial is a registrational trial of selinexor in patients with rrDLBCL. Results of this trial demonstrated an ORR of 28.3% and a complete response (CR) of 12% in all patients, and an ORR of 34% in patients with the germinal center B-cell (GCB) subtype.

Depei Wu, MD, chairman of the Chinese Society of Hematology of the Chinese Medical Association, and director of the hematology department at the First Affiliated Hospital of Soochow University, said: "DLBCL is a highly heterogeneous hematologic malignancy, and a type of heterogeneous and invasive lymphoma with a large transformed B-cell phenotype that leads to the diffuse damage to normal lymph nodes. Patients with DLBCL commonly have high XPO1 expression that indicates a poor prognosis. The world’s first approved oral XPO1 inhibitor, selinexor, has been recommend by the National Comprehensive Cancer Network (NCCN) Guidelines for the treatment of patients with DLBCL that have received least two prior lines of therapy (including those with disease progression after transplant or CAR-T therapy). The recommendation of selinexor by the 2021 CSCO Guidelines for Diagnosis and Treatment of Lymphoma offers a new treatment option to patients. We are confident that selinexor will soon benefit more patients in need."

Wenming Chen, MD, Chairman of the Chinese Medical Education Association Committee on Hematology, and director of the hematology department at Beijing Chao-Yang Hospital of the Capital Medical University, commented: "MM is a common type of hematologic malignancy. The survival of patients with MM has been steadily prolonged, thanks to the development and introduction of some new therapies in the recent years. But these patients still lack curative treatment and would eventually relapse after developing acquired drug-resistance. Enabled by its unique mechanism of action, selinexor can effectively address drug-resistance in MM and deliver deep response in lymphoma patients in various states of the disease. This recommendation by the CSCO Guidelines brings a new treatment option into the clinical setting. We look forward to seeing more patients benefit from selinexor."

About Selinexor (XPOVIO)

Selinexor, a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including Greater China, South Korea, Australia, New Zealand and the ASEAN countries.

In July 2019, the US Food and Drug Administration (FDA) approved selinexor in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma (rrMM) and in June 2020 approved selinexor as a single-agent for the treatment of relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL). In December 2020, selinexor also received FDA approval as a combination treatment for multiple myeloma (MM) after at least one prior therapy. In February 2021, selinexor was approved by the Israeli Ministry of Health for the treatment of patients with rrMM or rrDLBCL and in March 2021, the European Commission (EC) has granted conditional marketing authorization for selinexor (NEXPOVIO) for the treatment of MM.

Selinexor is so far the first and only oral SINE compound approved by the FDA and is the first drug approved for the treatment of both MM and DLBCL. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene’s partner, Karyopharm, presented positive results from the Phase III randomized, double blind, placebo controlled, cross-over SEAL trial evaluating single agent, oral selinexor versus matching placebo in patients with liposarcoma. Karyopharm also announced that the ongoing Phase III SIENDO trial of selinexor in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the trial should proceed as planned without any modifications. Top-line SIENDO trial results are expected in the second half of 2021.

Antengene is currently conducting five mid- or late-stage clinical trials of selinexor for the treatment of MM, DLBCL, non-small cell lung cancer, and peripheral T and NK/T-cell lymphoma. Furthermore, Antengene has submitted New Drug Applications (NDAs) for selinexor in five Asia Pacific markets including mainland China, Australia, South Korea, Singapore and Hong Kong, and was granted the Priority Review status by China’s NMPA and an Orphan Drug Designation by the Ministry of Food and Drug Safety of South Korea (MFDS).

On May 5, 2021 US Medical Innovations, LLC (USMI) reported that it is developing the first robotic delivery system used for cancer surgery (Press release, US Medical Innovations, MAY 5, 2021, View Source [SID1234579229]).

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The new Canady Surgical System (CSS) is a space-efficient, cost-effective, stand-alone solution for Robotic Assisted Surgery during open, laparoscopic/mini-invasive, endoscopic, thoracoscopic and trans-oral surgical procedures.

Features of the new Canady Surgical System include Voice Command technology which frees up the surgeon and assistant to focus on the surgical procedure and perform other tasks. The system includes both Canady Hybrid Plasma (CHP) and Canady Helios Cold Atmospheric Plasma (CHCAP) as well as a flexible disposable scope and camera system.

Preloaded in the CSS are treatment-dosage protocols for over 30 different cancer types and a robotic assisted image-guided navigational mapping system that delivers personalized and targeted CHCAP cancer treatments directly to the surgical site and ablating any remaining cancer cells after the tumor is removed with the CHP.

According to Jerome Canady, MD, and CEO of USMI, "Our CHCAP technology actually ablates cancer cells without damaging surrounding healthy tissue. We recently completed a Phase 1 FDA Clinical Trail using Canady Helios Cold Atmospheric Plasma (CHCAP) for the treatment of recurrent and stage 4 solid tumors. We see this novel technology, delivered with the precision of robotic assisted technology, as the most exciting new form of personalized and targeted medicine being explored today."

CHCAP has many advantages. It is performed during the surgical procedure. It is highly selective because it only targets cancer cells. And thirdly, the CHCAP treatment is personalized for specific cancer types (i.e., breast, ovarian, sarcoma, lung, colon, cervical, pancreas and other solid cancerous tumors).

The organization expects to have the new Canady Surgical System in clinical trials later this year. Protocols and site locations are being explored at this time.

On May 5, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported data on its 15-gene expression profile (15-GEP) test, DecisionDx-UM, at the Association for Research in Vision and Ophthalmology (ARVO) 2021: Revolutionary Eye and Vision Research Meeting (Press release, Castle Biosciences, MAY 5, 2021, View Source [SID1234579228]).

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The virtual poster is entitled "Uveal Melanoma Patient Attitudes Towards Prognostic Testing Using Gene Expression Profiling."

DecisionDx-UM, the test highlighted in the poster, is Castle’s prognostic 15-GEP test for patients with uveal melanoma, a rare cancer of the eye that carries a high risk of spreading (metastasizing). The DecisionDx-UM test is designed to accurately identify patients who are at low risk (Class 1) or high risk (Class 2) of metastasis based on the unique biology of their primary tumor and is the current standard of care in the management of uveal melanoma at the majority of U.S. ocular oncology practices.

"Up to half of patients diagnosed with uveal melanoma will experience metastatic disease, and prior studies show that newly diagnosed patients have overwhelmingly been in favor of learning their prognoses," said first author Basil K. Williams, M.D., assistant professor and director of Ocular Oncology at the University of Cincinnati College of Medicine. "This study demonstrated that uveal melanoma patients were satisfied with their decisions to pursue prognostic information through GEP testing, and they found particular value in DecisionDx-UM’s ability to help them understand their individual metastatic risk."

Study methods and findings:

The objective of the patient-based study was to understand uveal melanoma patients’ experiences following testing with DecisionDx-UM compared to patients with alternative or no prognostic testing.
An online questionnaire was distributed by the Melanoma Research Foundation’s CURE OM (Ocular Melanoma) initiative that captured de-identified information regarding patient-reported experiences. Patients were asked questions regarding the decision to undergo prognostic testing and the extent to which they felt regret about their decisions.
Of the 177 survey participants, 159 (90%) reported wanting prognostic information at diagnosis.
Of patients tested with DecisionDx-UM, the vast majority (80/81 respondents, 99%) reported gaining value from their test result, including:
Increased knowledge and understanding
More personalized treatment options
Information relevant to life planning
A sense of relief from uncertainty about the future
Of the patients who received prognostic testing with DecisionDx-UM, decision regret levels did not differ depending on whether they received a low or high-risk test result (Kruskal-Wallis; n=28, 23, 30 for 1A, 1B, 2; p=0.13).
Patients who received prognostic testing experienced lower levels of decision regret than those who opted out of testing, independent of which prognostic tests were used (Wilcoxon Rank-Sum tests: DecisionDx-UM vs. alternative tests: p=0.89, DecisionDx-UM vs. opt-out: p=0.0002, alternative tests vs. opt-out: p=0.003).